Diagnosis and Treatment of Cervical Radiculopathy from Degenerative

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NASS Clinical Guidelines – Diagnosis and Treatment of Cervical Radiculopathy from Degenerative Disorders 1 North American Spine Society Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care

Diagnosis and Treatment of Cervical Radiculopathy from Degenerative Disorders

NASS Evidence-Based Guideline Development Committee Christopher M. Bono, MD, Committee Chair Robert Fernand, MD Gary Ghiselli, MD, Outcome Measures Chair Tim Lamer, MD Thomas J. Gilbert, MD, Diagnosis/Imaging Chair Paul Matz, MD D. Scott Kreiner, MD, Medical/Interventional Chair Dan Mazanec, MD Charles Reitman, MD, Surgical Treatment Chair Daniel K. Resnick, MD Jeffrey Summers, MD, Natural History Chair William O. Shaffer, MD Jamie Baisden, MD Anil Sharma, MD John Easa, MD Reuben Timmons, MD John Toton, MD

Financial Statement This clinical guideline was developed and funded in its entirety by the North American Spine Society (NASS). All participating authors have submitted a disclosure form relative to potential conflicts of interest which is kept on file at NASS.

Comments Comments regarding the guideline may be submitted to the North American Spine Society and will be considered in development of future revisions of the work.

North American Spine Society Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care Diagnosis and Treatment of Cervical Radiculopathy from Degenerative Disorders

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ISBN: 1-929988-25-7

Table of Contents

I. Introduction ...... 4

II. Guideline Development Methodology ...... 5

III. Natural History of Cervical Radiculopathy from Degenerative Disorders...... 9

IV. Recommendations for Diagnosis and Treatment of Cervical Radiculopathy from Degenerative Disorders A. Diagnosis/Imaging...... 12 B. Outcome Measures for Treatment...... 31 C. Medical and Interventional Treatment...... 41 D. Surgical Treatment...... 50

V. Appendices A. Acronyms...... 72 B. Levels of Evidence for Primary Research Questions...... 73 C. Grades of Recommendations for Summaries or Reviews of Studies...... 74 D. Protocol for NASS Literature Searches...... 75 E. Literature Search Parameters...... 77 F. Evidentiary Tables...... 86

VI. References...... 168

Through objective evaluation of the evidence and and exercises, or interactivities, to prepare guideline transparency in the process of making recommen- developers for systematically evaluating literature dations, it is NASS’ goal to develop evidence-based and developing evidence-based guidelines. The on- clinical practice guidelines for the diagnosis and line course takes approximately 15-30 hours to com- treatment of adult patients with various spinal con- plete, and participants have been awarded CME ditions. These guidelines are developed for educa- credit upon completion of the course. tional purposes to assist practitioners in their clinical decision-making processes. It is anticipated that Disclosure of Potential Conflicts of where evidence is very strong in support of recom- Interest mendations, these recommendations will be opera- All participants involved in guideline development tionalized into performance measures. have disclosed their relationships with other entities and potential conflicts of interest to their colleagues Multidisciplinary Collaboration and their potential conflicts have been documented With the goal of ensuring the best possible care for for future reference. They will not be published in adult patients suffering with spinal disorders, NASS any guideline, but kept on file for reference, if need- is committed to multidisciplinary involvement in ed. Participants have been asked to update their dis- the process of guideline and performance measure closures regularly throughout the guideline devel- development. To this end, NASS has ensured that opment process. representatives from medical, interventional and surgical spine specialties have participated in the Levels of Evidence and Grades of development and review of all NASS guidelines. It is also important that primary care providers and Recommendation musculoskeletal specialists who care for patients NASS has adopted standardized levels of evidence with spinal complaints are represented in the de- (Appendix B) and grades of recommendation (Ap- velopment and review of guidelines that address pendix C) to assist practitioners in easily under- treatment by first contact physicians, and NASS has standing the strength of the evidence and recom- involved these providers in the development pro- mendations within the guidelines. The levels of cess as well. To ensure broad-based representation, evidence range from Level I (high quality random- NASS has invited and welcomes input from other ized controlled trial) to Level V (expert consensus). societies and specialties. Grades of recommendation indicate the strength of the recommendations made in the guideline based Evidence Analysis Training of All on the quality of the literature. NASS Guideline Developers Grades of Recommendation: NASS has initiated, in conjunction with the Universi- A: Good evidence (Level I studies with consistent ty of Alberta’s Centre for Health Evidence, an online findings) for or against recommending interven- training program geared toward educating guideline tion. developers about evidence analysis and guideline development. All participants in guideline develop- B: Fair evidence (Level II or III studies with consis- ment for NASS have completed the training prior to tent findings) for or against recommending in- participating in the guideline development program tervention. at NASS. This training includes a series of readings

C: Poor quality evidence (Level IV or V studies) for In addition, a number of studies were reviewed sev- or against recommending intervention. eral times in answering different questions within I: Insufficient or conflicting evidence not allowing this guideline. How a given question was asked a recommendation for or against intervention. might influence how a study was evaluated and interpreted as to its level of evidence in answering Guideline recommendations are written utilizing that particular question. For example, a random- a standard language that indicates the strength of ized control trial reviewed to evaluate the differenc- the recommendation. “A” recommendations indi- es between the outcomes of surgically treated ver- cate a test or intervention is “recommended”; “B” sus untreated patients with lumbar spinal stenosis recommendations “suggest” a test or intervention might be a well designed and implemented Level I and “C” recommendations indicate a test or inter- therapeutic study. This same study, however, might vention “may be considered” or “is an option.” “I” or be classified as giving Level II prognostic evidence “Insufficient Evidence” statements clearly indicate if the data for the untreated controls were extracted that “there is insufficient evidence to make a - rec and evaluated prognostically. ommendation for or against” a test or intervention. Work group consensus statements clearly state that Guideline Development Process “in the absence of reliable evidence, it is the work group’s opinion that” a test or intervention may be  Step 1: Identification of Clinical Questions appropriate. Trained guideline participants were asked to submit The levels of evidence and grades of recommenda- a list of clinical questions that the guideline should tion implemented in this guideline have also been address. The lists were compiled into a master list, adopted by the Journal of Bone and Joint Surgery, which was then circulated to each member with the American Academy of Orthopaedic Surgeons, a request that they independently rank the ques- Clinical Orthopaedics and Related Research, the tions in order of importance for consideration in journal Spine and the Pediatric Orthopaedic Society the guideline. The most highly ranked questions, as of North America. determined by the participants, served to focus the guideline. In evaluating studies as to levels of evidence for this guideline, the study design was interpreted as es-  Step 2: Identification of Work Groups tablishing only a potential level of evidence. As an Multidisciplinary teams were assigned to work example, a therapeutic study designed as a random- groups and assigned specific clinical questions to ad- ized controlled trial would be considered a poten- dress. Because NASS is comprised of surgical, medi- tial Level I study. The study would then be further cal and interventional specialists, it is imperative analyzed as to how well the study design was imple- to the guideline development process that a cross- mented and significant short comings in the execu- section of NASS membership is represented on each tion of the study would be used to downgrade the group. This also helps to ensure that the potential for levels of evidence for the study’s conclusions. In the inadvertent biases in evaluating the literature and example cited previously, reasons to downgrade the formulating recommendations is minimized. results of a potential Level I randomized controlled trial to a Level II study would include, among other  Step 3: Identification of Search Terms and possibilities: an underpowered study (patient sam- Parameters ple too small, variance too high), inadequate ran- One of the most crucial elements of evidence analy- domization or masking of the group assignments sis to support development of recommendations for and lack of validated outcome measures. appropriate clinical care is the comprehensive litera-

ture search. Thorough assessment of the literature is radiculopathy alone or include a subgroup analysis the basis for the review of existing evidence and the of patients with radiculopathy. Many of the studies formulation of evidence-based recommendations. considered for potential inclusion in this guideline In order to ensure a thorough literature search, NASS included groups of patients with myelopathy, with- has instituted a Literature Search Protocol (Appen- out appropriate subgroup analyses of those patients dix D) which has been followed to identify literature with cervical radiculopathy alone. For this reason, for evaluation in guideline development. In keep- in the absence of subgroup analyses, a large number ing with the Literature Search Protocol, work group of studies were excluded from consideration in ad- members have identified appropriate search terms dressing the questions and formulating recommen- and parameters to direct the literature search. dations. These studies, having been reviewed, are included in the reference sections. Specific search strategies, including search terms, parameters and databases searched, are document-  Step 6: Evidence Analysis ed in the appendices (Appendix E). Members have independently developed evidentiary tables summarizing study conclusions, identify-  Step 4: Completion of the Literature ing strengths and weaknesses and assigning levels Search of evidence. In order to systematically control for Once each work group identified search terms/pa- potential biases, at least two work group members rameters, the literature search was implemented by have reviewed each article selected and indepen- a medical/research librarian, consistent with the dently assigned levels of evidence to the literature Literature Search Protocol. using the NASS levels of evidence. Any discrepan- Following these protocols ensures that NASS recom- cies in scoring have been addressed by two or more mendations (1) are based on a thorough review of reviewers. The consensus level (the level upon which relevant literature; (2) are truly based on a uniform, two-thirds of reviewers were in agreement) was then comprehensive search strategy; and (3) represent assigned to the article. the current best research evidence available. NASS As a final step in the evidence analysis process, maintains a search history in Endnote, for future use members have identified and documented gaps in or reference. the evidence to educate guideline readers about where evidence is lacking and help guide further  Step 5: Review of Search Results/ needed research by NASS and other societies. Identification of Literature to Review Work group members reviewed all abstracts yielded  Step 7: Formulation of Evidence-Based from the literature search and identified the litera- Recommendations and Incorporation of ture they will review in order to address the clini- Expert Consensus cal questions, in accordance with the Literature Work groups held webcasts to discuss the evidence- Search Protocol. Members have identified the best based answers to the clinical questions, the grades of research evidence available to answer the targeted recommendations and the incorporation of expert clinical questions. That is, if Level I, II and or III lit- consensus. Expert consensus has been incorporat- erature is available to answer specific questions, the ed only where Level I-IV evidence is insufficient and work group was not required to review Level IV or the work group has deemed that a recommendation V studies. Work group members reviewed the evi- is warranted. Transparency in the incorporation of dence on the topic of cervical radiculopathy, and consensus is crucial, and all consensus-based rec- studies eligible for review were required to address

ommendations made in this guideline very clearly Following NASS Board approval, the guidelines have indicate that Level I-IV evidence is insufficient to been slated for publication, submitted for endorse- support a recommendation and that the recom- ment to all appropriate societies and submitted for mendation is based only on expert consensus. inclusion in the National Guidelines Clearinghouse (NGC). No revisions were made at this point in the Consensus Development Process process, but comments have been and will be saved Voting on guideline recommendations was conduct- for the next iteration. ed using a modification of the nominal group technique in which each work group member indepen-  Step 11: Identification and Development of dently and anonymously ranked a recommendation Performance Measures on a scale ranging from 1 (“extremely inappropri- The recommendations will be reviewed by a group ate”) to 9 (“extremely appropriate”). Consensus was experienced in performance measure development obtained when at least 80% of work group members (eg, the AMA Physician’s Consortium for Perfor- ranked the recommendation as 7, 8 or 9. When the mance Improvement) to identify those recommen- 80% threshold was not attained, up to three rounds dations rigorous enough for measure develop- of discussion and voting were held to resolve dis- ment. All relevant medical specialties involved in agreements. If disagreements were not resolved af- the guideline development and at the Consortium ter these rounds, no recommendation was adopted. will be invited to collaborate in the development of evidence-based performance measures related to After the recommendations were established, work spine care. group members developed the guideline content, addressing the literature which supports the recom-  Step 12: Review and Revision Process mendations. The guideline recommendations will be reviewed every three years by an EBM-trained multidisci-  Step 8: Submission of the Draft Guidelines plinary team and revised as appropriate based on a for Review/Comment thorough review and assessment of relevant litera- Guidelines were submitted to the full Evidence- ture published since the development of this version Based Guideline Development Committee and the of the guideline. Research Council Director for review and comment. Revisions to recommendations were considered for Use of Acronyms incorporation only when substantiated by a prepon- Throughout the guideline, readers will see many ac- derance of appropriate level evidence. ronyms with which they may not be familiar. A glos- sary of acronyms is available in Appendix A.  Step 9: Submission for Board Approval Once any evidence-based revisions were incor- Nomenclature for Medical/Interventional porated, the drafts were prepared for NASS Board Treatment review and approval. Edits and revisions to recom- Throughout the guideline, readers will see that what mendations and any other content were considered has traditionally been referred to as “nonoperative,” for incorporation only when substantiated by a pre- “nonsurgical” or “conservative” care is now referred ponderance of appropriate level evidence. to as “medical/interventional care.” The term medical/interventional is meant to encompass pharma-  Step 10: Submission for Endorsement, cological treatment, physical therapy, exercise ther- Publication and National Guideline apy, manipulative therapy, modalities, various types Clearinghouse (NGC) Inclusion of external stimulators and injections.

What is the best working definition measures.5,12,18,22,28 In other investigations, data were reported for untreated and conservatively-treated of cervical radiculopathy from patients together without an analysis specific to the degenerative disorders? untreated group. Other commonly cited studies did not report subgroup analyses of patients with cervical radiculopathy alone and thereby presented gen- eralized natural history data regarding a heteroge- Cervical radiculopathy from degenerative neous cohort of patients with isolated neck pain, disorders can be defined as pain in a radicular cervical radiculopathy or cervical myelopathy. pattern in one or both upper extremities related to compression and/or irritation of Because of the limitations of available literature, the one or more cervical nerve roots. Frequent work group was unable to definitively answer the signs and symptoms include varying degrees question posed related to the natural history of cer- of sensory, motor and reflex changes as well vical radiculopathy from degenerative disorders. In as dysesthesias and paresthesias related to lieu of an evidence-based answer, the work group nerve root(s) without evidence of spinal cord did reach consensus on the following statement ad- dysfunction (myelopathy). dressing natural history. Work Group Consensus Statement It is likely that for most patients with cervical radiculopathy from degenerative disorders What is the natural history of cer- signs and symptoms will be self-limited and will resolve spontaneously over a variable length of vical radiculopathy from degener- time without specific treatment. ative disorders? Work Group Consensus Statement To address the natural history of cervical radiculopathy from degenerative disorders, the work group Future Directions for Research performed a comprehensive literature search and The work group identified the following potential analysis. The group reviewed 31 articles that were studies, which could generate meaningful evidence selected from a search of MEDLINE (PubMed), Co- to assist in further defining the natural history of chrane Register of Controlled Trials, Web of Science cervical radiculopathy from degenerative disorders. and EMBASE Drugs & Pharmacology. However, all identified studies failed to meet the guideline’s in- Recommendation #1: clusion criteria because they did not ade-quately A prospective study of patients with cervical radicu- present data about the natural history of cervical lopathy from degenerative disorders without treat- radiculopathy. The plurality of studies did not re- ment, notwithstanding nonprescription analgesics, port results of untreated patients, thus limiting con- would provide Level I evidence regarding the natu- clusions about natural history. This includes works ral history of this disorder. that have been frequently cited as so-called natural history studies but are in fact reports of the results Recommendation #2: of one or more medical/interventional treatment A systematic study of patients with untreated cer-

This clinical guideline should not be construed as including all proper methods of care or excluding other acceptable methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding any specific procedure or treatment is to be made by the physician and patient in light of all circumstances presented by the patient and the needs and resources particular to the locality or institution. NASS Clinical Guidelines – Diagnosis and Treatment of Cervical Radiculopathy from Degenerative Disorders 10 vical radiculopathy from degenerative disorders cal approach to the management of patients with cervical would provide evidence regarding the natural his- radiculopathy: A prospective observational cohort study. J tory of the disease in this patient population. Manipulative Physiol Ther. May 2006;29(4):279-287. 15. Peng B, Hao J, Hou S, et al. Possible pathogenesis of painful intervertebral disc degeneration. Spine. Mar 1 Natural History References 2006;31(5):560-566. 1. Anderberg L, Annertz M, Persson L, Brandt L, Saveland H. 16. Petren-Mallmin M, Linder J. Cervical spine degeneration Transforaminal steroid injections for the treatment of cer- in fighter pilots and controls: a 5-yr follow-up study.Aviat vical radiculopathy: a prospective and randomised study. Space Environ Med. May 2001;72(5):443-446. Eur Spine J. Mar 2007;16(3):321-328. 17. Petren-Mallmin M, Linder J. MRI cervical spine findings 2. Carette S, Fehlings MG. Clinical practice. Cervical radicu- in asymptomatic fighter pilots. Aviat Space Environ Med. lopathy. N Engl J Med. Jul 28 2005;353(4):392-399. Dec 1999;70(12):1183-1188. 3. Garvey TA, Eismont FJ. Diagnosis and treatment of cer- 18. Radhakrishnan K, Litchy WJ, O’Fallon WM, Kurland LT. vical radiculopathy and myelopathy. Orthop Rev. Jul Epidemiology of cervical radiculopathy. A population- 1991;20(7):595-603. based study from Rochester, Minnesota, 1976 through 4. Gore DR, Carrera GF, Glaeser ST. Smoking and degen- 1990. Brain. Apr 1994;117 ( Pt 2):325-335. erative changes of the cervical spine: a roentgenographic 19. Rao R. Neck pain, cervical radiculopathy, and cervical my- study. Spine J. Sep-Oct 2006;6(5):557-560. elopathy: pathophysiology, natural history, and clinical 5. Gore DR, Sepic SB, Gardner GM, Murray MP. Neck pain: evaluation. J Bone Joint Surg Am. Oct 2002;84-A(10):1872- a long-term follow-up of 205 patients. Spine. Jan-Feb 1881. 1987;12(1):1-5. 20. Ross JS, Modic MT, Masaryk TJ, Carter J, Marcus RE, Bohl- 6. Hamalainen O, Toivakka-Hamalainen SK, Kuronen P. +Gz man H. Assessment of extradural degenerative disease associated stenosis of the cervical spinal canal in fighter with Gd-DTPA-enhanced MR imaging: correlation with pilots. Aviat Space Environ Med. Apr 1999;70(4):330-334. surgical and pathologic findings.AJR Am J Roentgenol. Jan 7. Harrop JS, Hanna A, Silva MT, Sharan A. Neurological 1990;154(1):151-157. manifestations of cervical spondylosis: an overview of 21. Rubin D. Cervical radiculitis: diagnosis and treatment. signs, symptoms, and pathophysiology. Neurosurgery. Jan Arch Phys Med Rehabil. Dec 1960;41:580-586. 2007;60(1 Supp1 1):S14-20. 22. Saal JS, Saal JA, Yurth EF. Nonoperative management of 8. Healy JF, Healy BB, Wong WH, Olson EM. Cervical and herniated cervical intervertebral disc with radiculopathy. lumbar MRI in asymptomatic older male lifelong athletes: Spine. Aug 1996;21(16):1877-1883. frequency of degenerative findings. J Comput Assist To- 23. Sambrook PN, MacGregor AJ, Spector TD. Genetic influ- mogr. Jan-Feb 1996;20(1):107-112. ences on cervical and lumbar disc degeneration: a mag- 9. Hendriksen IJ, Holewijn M. Degenerative changes of the netic resonance imaging study in twins. Arthritis Rheum. spine of fighter pilots of the Royal Netherlands Air Force Feb 1999;42(2):366-372. (RNLAF). Aviat Space Environ Med. Nov 1999;70(11):1057- 24. Sampath P, Bendebba M, Davis JD, Ducker T. Outcome in 1063. patients with cervical radiculopathy. Prospective, multi- 10. Humphreys SC, Hodges SD, Patwardhan A, Eck JC, Coving- center study with independent clinical review. Spine. Mar ton LA, Sartori M. The natural history of the cervical fora- 15 1999;24(6):591-597. men in symptomatic and asymptomatic individuals aged 25. Swezey RL. Conservative treatment of cervical radiculop- 20-60 years as measured by magnetic resonance imaging. athy. J Clin Rheumatol. Apr 1999;5(2):65-73. A descriptive approach. Spine. Oct 15 1998;23(20):2180- 26. Teresi LM, Lufkin RB, Reicher MA, et al. Asymptomatic 2184. degenerative disk disease and spondylosis of the cervical 11. Kang JD, Stefanovic-Racic M, McIntyre LA, Georgescu spine: MR imaging. Radiology. Jul 1987;164(1):83-88. HI, Evans CH. Toward a biochemical understanding of 27. Van Zundert J, Harney D, Joosten EA, et al. The role of the human intervertebral disc degeneration and herniation. dorsal root ganglion in cervical radicular pain: diagnosis, Contributions of nitric oxide, interleukins, prostaglan- pathophysiology, and rationale for treatment. Reg Anesth din E2, and matrix metalloproteinases. Spine. May 15 Pain Med. Mar-Apr 2006;31(2):152-167. 1997;22(10):1065-1073. 28. Wainner RS, Gill H. Diagnosis and nonoperative manage- 12. Lees F, Turner JW. Natural history and prognosis of cervi- ment of cervical radiculopathy. J Orthop Sports Phys Ther. cal spondylosis. Br Med J. Dec 28 1963;2(5373):1607-1610. Dec 2000;30(12):728-744. 13. Murphey F, Simmons JC, Brunson B. Chapter 2. Ruptured 29. Yoo K, Origitano TC. Familial cervical spondylosis. Case cervical discs, 1939 to 1972. Clin Neurosurg. 1973;20:9-17. report. J Neurosurg. Jul 1998;89(1):139-141. 14. Murphy DR, Hurwitz EL, Gregory A, Clary R. A nonsurgi- 30. Yoshida M, Tamaki T, Kawakami M, Hayashi N, Ando M.

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A. Diagnosis and Imaging What history and physical exami- was 73.8%, 84.8% and 83.5%, respectively. There was a 71.5% incidence of correlation between preopera- nation findings best support a di- tive clinical findings and operative findings. Good or agnosis of cervical radiculopathy excellent results were reported by 91.5% of patients. Good or excellent relief of arm pain was found in from degenerative disorders? 95.5% of patients, neck pain in 88.8%, scapular pain in 95.9%, chest pain in 95.4% and headache RECOMMENDATION: It is suggested that the in 89.8%. Resolution of DTR abnormalities was re- diagnosis of cervical radiculopathy be considered ported in 96.9%. Residual sensory deficit was found in patients with arm pain, neck pain, scapular or in 20.9% of patients and motor deficit in 2.3%. In a periscapular pain, and paresthesias, numbness large group of patients with cervical radiculopathy, and sensory changes, weakness, or abnormal this study elucidates the common clinical findings deep tendon reflexes in the arm. These are the of pain, paresthesia, motor deficit and decreased most common clinical findings seen in patients DTRs, along with their respective frequencies. These with cervical radiculopathy. data present evidence that the surgical site can be accurately predicted on the basis of clinical findings Grade of Recommendation: B 71.5% of the time.

30 Henderson et al presented findings of a retrospec- In critique, no validated outcome measures were tive observational study reporting results of PLF in used in the study. Thus, it provides Level II evidence the treatment of 736 patients with cervical radicul- that 71.5% of the time, the surgical site can be accu- opathy. Patients included in the study reported the rately predicted on the basis of clinical findings. following symptoms: arm pain (99.4%), neck pain (79.7%), scapular pain (52.5%), anterior chest pain Jenis et al31 described a retrospective case series re- (17.8%) and headache (9.7%). Eleven patients pre- porting the results of surgical intervention in 11 cer- sented with only left chest and arm pain (“cervical vical radiculopathy patients with neck pain from C4 angina”). Pain or paresthesia in a dermatomal pat- radiculopathy. Pain was localized to the posterior tern was reported by 53.9% of patients, while 45.5% aspect of the neck and lateralized to the side with C4 experienced pain or paresthesia in a diffuse or non- root involvement. Pain was also reported in trape- dermatomal pattern. No pain or paresthesia was re- zial areas and upper extremities depending on the ported by 0.6% of patients. Of patients included in presence of more caudal radiculopathies. Neck pain the study, 85.2% reported a sensory change to pin- was exacerbated by flexion and extension in all pa- prick, 68% had a specific motor deficit and 71.2% tients. Decreased sensation in the C4 dermatome had a specific decrease in a DTR. One nerve root was present in all patients. MRI was obtained in all level was thought to be primarily responsible for patients and CT scan in three patients prior to sur- symptoms in 87.3% of patients and two levels were gery. Excluding a single myelopathic patient, four felt to be equally involved for the remaining 12.7%. patients were treated with anterior cervical discec- The correlation between pain/paresthesia, motor tomy and fusion (ACDF) and seven with posterior deficit, DTR change and the primary operative level

foraminotomy (PLF). Evaluating fusion status, pain identifying the level involved. Patients underwent relief and level of activity based on Odom’s criteria, single level nerve root decompression using a pos- good or excellent results were obtained in 10 of the terior open foraminotomy. The surgical level was 11 patients. The authors concluded that patients with determined by correlation of symptoms and imag- neck pain should be evaluated for C4 radiculopathy, ing, with selective nerve root block (SNRB) in five the examination should include C4 sensory testing, patients. Cervical disc herniation (CDH) was found and neck pain from C4 radiculopathy can respond in 20 patients and stenosis in 30. Neck or scapu- to surgical decompression unlike neck pain arising lar pain preceeded the arm/finger symptoms in 35 from degenerative disc disease. patients (70%) and was relieved early in 46 (92%). When the pain was suprascapular, C5 or C6 radicu- In critique, no validated outcome measures were lopathy was frequent; when interscapular, C7 or C8 used and the sample size was small. This study pro- radiculopathy was frequent; and when scapular, C8 vides Level IV evidence that neck pain with or with- was frequent. Arm and finger symptoms improved out upper extremity clinical findings should prompt significantly in all groups after decompression. Six- evaluation for a C4 radiculopathy and that this eval- ty-one painful sites were noted before surgery: one uation should include C4 sensory testing. in 39 patients and two in 11 patients. One month after surgery, 27 patients reported complete pain re- Post et al38 reported a retrospective case series relief, 23 complained of pain in 24 subregions, seven viewing experience with the surgical management of which were the same as before surgery. Seven- of a series of 10 patients with C7-T1 herniations. teen pain sites were new since surgery. All but one Symptoms included shoulder pain radiating into new site were nuchal and suprascapular. At one year the lateral aspect of the hand, hand weakness and follow-up, 45 patients reported no pain, five patients weakness in finger flexion, finger extension and in- had pain in six sites, three of which were the same as trinsic hand muscles. Sensation and DTRs were un- before surgery. The authors concluded that pain in remarkable. MRI on each patient revealed a soft disc the suprascapular, interscapular or scapular regions compressing the C8 nerve root. Recovery of hand can orginate from a compressed cervical nerve root strength was noted in each patient; however, recov- and is valuable for determing the nerve root in- ery was incomplete in two patients with symptoms volved. greater than four months. In critique, no validated outcome measures were used and the sample size This study provides Level I evidence that cervical ra- was small. This study provides Level IV evidence diculopathy at C5, C6, C7 and C8 frequently causes that C8 radiculopathy usually presents as weakness pain in suprascapular, interscapular and scapular of the hand and pain radiating to shoulder, scapu- areas and is useful in determining the level of nerve lar area, and to the fourth and fifth fingers. Physi- root involvement. Pain in the suprascapular region cal exam may reveal normal sensation and DTRs. suggests C5 or C6 radiculopathy, pain in the inter- Motor examination may show weakness of finger scapular region suggests C7 or C8 radiculopathy, flexion and extension and weakness of the intrinsic and pain in the scapular region suggests C8 radicu- muscles of the hand. lopathy.

Tanaka et al48 described a prospective observational Yoss et al55 conducted a retrospective observational study examining whether or not pain in the neck or study of 100 patients to correlate clinical findings scapular regions in 50 consecutive patients with cer- with surgical findings when a single cervical nerve vical radiculopathy originated from a compressed root (C5, C6, C7, C8) is compressed by a disc hernia- nerve root, and whether the site of pain is useful for tion. Symptoms included pain in the neck, shoulder,

scapular or interscapular regions, arm, forearm or and signs are often present in patients with hand; paresthesias in forearm, and hand; and weak- cervical radiculopathy, and can improve with ness of upper extremity. Signs included diminution treatment. of triceps, biceps and brachioradialis reflexes, mus- Grade of Recommendation: B cle weakness and sensory loss. Pain or paresthesia in the neck, shoulder, scapular or interscapular Henderson et al30 presented findings of a retrospec- region were present in cases of C5, C6, C7 or C8 tive observational study reporting results of PLF in compression. The presence of pain in the arm cor- the treatment of 736 patients with cervical radicul- responded to the site compression in 23% of cases. opathy. Patients included in the study reported the The presence of pain or paresthesia in the forearm following symptoms: arm pain (99.4%), neck pain corresponded to a single root or one of two roots in (79.7%), scapular pain (52.5%), anterior chest pain 32% and 66%, respectively. Hand pain and paresthe- (17.8%) and headache (9.7%). Eleven patients pre- sia corresponded to a single root or one of two roots sented with only left chest and arm pain (“cervical in 70% and 27%, respectively. Subjective weakness angina”). Pain or paresthesia in a dermatomal pat- corresponded to a single level in 22/34 (79%) cases. tern was reported by 53.9% of patients, while 45.5% experienced pain or paresthesia in a diffuse or non- When a diminution of DTR was present, the lesion dermatomal pattern. No pain or paresthesia was re- could be correctly localized to a single level or one ported by 0.6% of patients. Of patients included in of two levels in 11% and 82%, respectively. Objective the study, 85.2% reported a sensory change to pin- muscle weakness corresponded to a single root or prick, 68% had a specific motor deficit and 71.2% one of two roots in 77% and 12%, respectively. In all had a specific decrease in a DTR. One nerve root cases in which the C5 and C8 nerve root was involved level was thought to be primarily responsible for and objective weakness was present, the level was symptoms in 87.3% of patients and two levels were correctly localized. Sensory loss corresponded to a felt to be equally involved for the remaining 12.7%. single root or one of two roots in 65% and 35%, re- The correlation between pain/paresthesia, motor spectively. The authors concluded that clinical find- deficit, DTR change and the primary surgical level ings related to the fingers are the most accurate for was 73.8%, 84.8% and 83.5%, respectively. There was localizing a CDH to a single level. A single level CDH a 71.5% incidence of correlation between presurgi- may produce signs and symptoms that correspond cal clinical findings and surgical findings. Good or to overlapping dermatomal levels. excellent results were reported by 91.5% of patients. Good or excellent relief of arm pain was found in This study provides Level II evidence that clinical 95.5% of patients, neck pain in 88.8%, scapular findings related to the fingers are the most accurate pain in 95.9%, chest pain in 95.4% and headache for localizing a CDH to a single level. Single level in 89.8%. Resolution of DTR abnormalities was re- CDH may produce signs and symptoms that corre- ported in 96.9%. Residual sensory deficit was found spond to overlapping dermatomal levels. in 20.9% of patients and motor deficit in 2.3%. In a large group of patients with cervical radiculopathy, RECOMMENDATION: It is suggested that the this study elucidates the common clinical findings diagnosis of cervical radiculopathy be considered of pain, paresthesia, motor deficit, and decreased in patients with atypical findings such as deltoid DTRs, along with their respective frequencies. These weakness, scapular winging, weakness of the data present evidence that the operative site can be intrinsic muscles of the hand, chest or deep accurately predicted on the basis of clinical findings breast pain, and headaches. Atypical symptoms 71.5% of the time.

In critique, no validated outcome measures were small study provides Level IV evidence that scapular used in the study. Thus, it provides Level II evidence winging can be a feature of C7 radiculopathy. that 71.5% of the time, the operative site can be accurately predicted on the basis of clinical findings. Ozgur et al35 described a retrospective case series of the presenting symptomatology of 241 consecutive Chang et al13 described a retrospective case series patients following C6-7 discectomy . Of the patients, identifying the characteristics of cervical radicul- 83% had typical C7 radicular signs while 17% had opathy causing deltoid paralysis, and reporting on atypical symptoms, 12% reporting isolated subscap- the surgical outcomes of ACDF for the treatment ular pain and 5% deep breast or chest pain. The au- of deltoid paralysis. All 14 patients had pain radiat- thors reported that patients presenting with atypical ing to the scapula, shoulder or arm, with weakness symptoms had correlative pathology confirmed by of shoulder abduction due to paralysis of deltoid surgical findings, 93% of whom experienced symp- (graded 0-5). Severity of radicular pain was graded tom relief. This study provides Level IV evidence on a visual analog scale (VAS) from zero to 10. Plain that a substantial percentage of patients may present radiographs and MRI were correlated with clinical with atypical symptoms associated with C7 nerve findings. Surgery was performed on patients with root compression single level CDH or cervical spondylotic radiculopathy (CSR). Patients with multilevel disease were Persson et al37 conducted a prospective observation- excluded. The following lists the single levels im- al study to describe the frequency of headaches in plicated in deltoid paralysis and their respective patients with lower level cervical radiculopathy and frequencies: 1-C3-4 CDH (central), 4-C4-5 CDH, its response to a selective nerve root block (SNRB). 1-C5-6 CDH, 3-C4-5 CSR, 5-C5-6 CSR. Both radicu- Of 275 patients, 161 suffered from daily or recurrent lopathy and deltoid paralysis improved significantly headaches, most often ipsilateral to the patients’ ra- with surgery. The authors found that a painful cervi- diculopathy. All patients underwent clinical exam cal radiculopathy with deltoid paralysis arose from and MRI. Patients with significantly compressed the C4-5, C5-6 and C3-4 levels in 50%, 43% and 7% nerve roots underwent SNRB. All patients with of the cases, respectively. This small study provides headaches had tender points in the neck/shoulder Level IV evidence that a painful cervical radiculopa- region ipsilateral to the radiculopathy. Patients with thy with deltoid paralysis can arise from compres- headache had significantly more limitations in daily sive disease at the C4-5, C5-6 or C3-4 levels. activities and higher pain in the neck/shoulder. Im- mediately before the injections, 161 (59%) of pa- Makin et al34 reported a retrospective case series of tients experienced a headache exceeding 15 on the six patients with scapular winging as a finding with VAS. Of these 161 patients, 101 (63%) experienced C7 radiculopathy. Scapular winging from serratus >25% headache reduction following SNRB, 93 (58%) anterior weakness was detected by pushing for- reported greater than 50% headache reduction, and ward against a wall with the hands at shoulder level 66 experienced 100% relief (C4 3%, C5 11%, C6 52%, or with the hands at waist level. The latter method C7 29%, C8 5%). A significant correlation was found places the serratus anterior muscle at a mechanical between reduced headache and decreased pain in disadvantage and reveals partial paralysis. Each case the neck and shoulder region. The authors conclud- of C7 compression was confirmed by surgical find- ed that cervical nerve root compression from degen- ings or by CT myelography. The authors concluded erative disease in the lower cervical spine produc- that scapular winging may be a component of C7 ing radiculopathy can also result in headache. Thus, radiculopathy and when present serves to exclude headache assessment together with muscle palpa- lesions of the brachial plexus or radial nerve. This tion should be part of the clinical exam for patients with cervical radiculopathy.

In critique, the study had a low (50%) threshold and gery and all achieved good results. Two of the 15 had lack of specificity for the injection. Because of these pain relief with conservative therapy. Of the seven limitations, this potential Level II study provides patients with negative shoulder abduction signs, five Level III evidence that complaint of a headache can required surgery and two were successfully treated be a symptom with C4-C8 nerve root compression. with traction. Of the five surgical patients, three had SNRB can reduce headache in a substantial percent- surgery for a central lesion and improved after sur- age of patients and may be a useful diagnostic tool. gery, two had surgery for a lateral disc fragment and only one had good results. The authors concluded Post et al38 reported a retrospective case series re- that the shoulder abduction test is a reliable indi- viewing experience with the surgical management cator of significant cervical extradural compressive of a series of 10 patients with C7-T1 herniations. radicular disease. Symptoms included shoulder pain radiating into the lateral aspect of the hand, hand weakness and In critique, no validated outcome measures were weakness in finger flexion, finger extension and used and the sample size was small. This study pro- intrinsic hand muscles. Sensation and DTRs were vides Level III evidence that relief from arm pain unremarkable. MRI on each patient revealed a soft with shoulder abduction is an indicator of cervical disc compressing the C8 nerve. Recovery of hand extradural compressive radiculopathy. strength was noted in each patient; however, recovery was incomplete in two patients with symptoms Shah et al45 conducted a prospective observational greater than four months. In critique, no validated study to determine the sensitivity and specificity of outcome measures were used and the sample size the Spurling’s test in predicting the diagnosis of a was small. This study provides Level IV evidence soft lateral CDH in 50 patients with neck and arm that C8 radiculopathy can present with weakness of pain. Spurling’s test with cervical extension, lateral the hand, and pain radiating to the shoulder, scapu- flexion to the side of pain, and downward pressure lar area, and fourth and fifth fingers. on the head was performed on all patients. Twenty- five patients underwent surgery (Group 1) and 25 RECOMMENDATION: Provocative tests includ- were managed conservatively (Group 2). Spurling’s ing the shoulder abduction and Spurling’s tests test was correlated with surgical findings in Group may be considered in evaluating patients with 1 and with MRI findings in Group 2. Patients with clinical signs and symptoms consistent with the their first episode of radicular pain and minimal or diagnosis of cervical radiculopathy. no neurologic deficits, and those who refused sur- Grade of Recommendation: C gery were managed conservatively. In Group 1, of the 18 patients with a positive Spurling’s test, all had Davidson et al16 described observations from a ret- surgically confirmed soft disc herniations. Of seven rospective case series of 22 patients with cervical patients with a negative Spurling’s test, two had a soft monoradiculopathy caused by compressive disease disc herniation and five had a hard disc. In Group 2, in whom clinical signs included relief of pain with of the 10 patients with a positive Spurling’s test, nine abduction of the shoulder. Twenty-two patients with had a soft disc herniation, one had a hard disc. Of arm pain had cervical extradural myelographic de- the 15 patients with a negative Spurling’s test, a hard fects. Of the 22 patients, 15 experienced relief from disc was seen in eight, and MRI was normal in seven. their pain with shoulder abduction. Motor weak- The Spurling’s test had a sensitivity of 92%, a specific- ness was present in 15, paresthesias in 11 and reflex ity of 95%, a positive predictive value (PPV) of 96.4% changes in nine patients. Of the 15 patients with a and a negative predictive power (NPP) of 90.9% for positive shoulder abduction sign, 13 required sur- a soft disc herniation. The authors concluded that

the high PPV of the test can be used to improve the Wainner et al51 described a prospective yield of postivie MRI examinations in patients with comparative study assessing the reliability and cervical radiculopathy . This study provides Level II accuracy of individual clinical exam items and evidence that a positive Spurling’s test improves the self reported instruments for the diagnosis of clinician’s ability to diagnose compressive disease cervical radiculopathy in 82 patients with a goal in patients with cervical radiculopathy. of identifying and assessing the accuracy of an optimal cluster of test items. Consecutive patients Tong et al49 performed a prospective comparative were referred for EMG for the evaluation of cervical study to determine the sensitivity and specificity of radiculopathy or carpal tunnel syndrome. Only the Spurling test for 255 patients referred for elec- patients judged by one of seven laboratory providers trodiagnosis of upper extremity nerve disorders. The to have signs and symptoms compatible with CR or Spurling test was performed on all patients before CTS were eligible to participate. Patients with Class electromyography (EMG). The test was scored as 5 or 6 cervical radiculopathy findings were further positive if it resulted in pain or tingling starting in the classified according to the severity of their EMG shoulder and radiating distally to the elbow. A dif- findings. Self-reported items included the VAS and ferential diagnosis based on the history and physical NDI. A standardized clinical exam was performed exam was made prior to EMG. EMG was performed by two of nine physical therapists and contained 34 and each diagnosis in the differential was scored rel- items. History contained six questions asked by two ative to the likelihood of its occurrence. Of the 255 physical therapists. Neurological exam included patients presented, 31 had missing data, leaving 224 strength, DTRs and sensation. Provocative tests patients for inclusion. Of 20 patients with a positive included Spurling’s test, shoulder abduction test, EMG for cervical radiculopathy, the Spurling’s test Valsalva maneuver, neck distraction test and the was positive in seven, for a sensitivity of 7/20 or 30%. upper limb tension test (ULTT). Cervical range Of 172 patients with no EMG evidence for radicul- of motion was also measured. Fifteen patients opathy, the Spurling’s test was negative in 160, for a had an EMG diagnosis of cervical radiculopathy, specificity of 160/172 or 93%. The Spurling’s test was and five patients were diagnosed with cervical positive in 16.6% of patients with a normal EMG, in radiculopathy and carpal tunnel sydrome, one with 3.4% of patients with an EMG diagnosis of a nerve concomitant ulnar neuropathy. One patient with problem other than radiculopathy, and in 15% of combined findings dropped out of the study. Of the patients with nonspecific EMG findings. The odds 19 patients reported, 13 had mild symptoms and ratio of a positive Spurling’s test in a patient with a six had moderate symptoms. Reliability of different positive EMG for cervical radiculopathy is 5.71. The clinical items was reported including the Spurling’s authors concluded that the Spurling’s test is not sen- A/B 0.6/0.62, shoulder abduction 0.2, valsalva 0.69, sitive but is specific for cervical radiculopathy as di- distraction 0.88, ULTT A/B 0.76/0.83. Sensitivity/ agnosed by EMG. Although not useful as a screening specificity: Spurling’s A/B 0.6/0.62, shoulder test, it may be useful to confirm the diagnosis. abduction 0.2, valsalva 0.69, distraction 0.88, ULTT A/B 0.76/0.83. Sensitivity/Specificity of different In critique, the study uses a poor reference standard clinical items was reported including the Spurling’s (EMG). This study provides Level IV evidence that A/B - 0.5/0.86 - 0.74; shoulder abduction - 0.17/0.92; the Spurling’s test is not sensitive but is specific for valsalva - .22/.94; distraction - 0.44/0.9; ULTT A/B cervical radiculopathy as diagnosed by EMG. Thus, - 0.72-0.97/0.22-0.33; Cluster of ULTT A, cervical a positive Spurling’s test is clinically useful in help- rotation <60degrees, distraction, and Spurling’s A - ing confirm the presence of cervical radiculopathy. 0.24/0.99. The authors concluded that many items were found to have at least a fair level of reliability

and to have acceptable diagnostic properties. The test item cluster identified was found to be the most Henderson et al30 presented findings of a retrospec- useful. tive observational study reporting results of PLF in the treatment of 736 patients with cervical radicul- In critique, the small study utilized EMG as a gold opathy. Patients included in the study reported the standard with an apparent test selection bias. Be- following symptoms: arm pain (99.4%), neck pain cause of these limitations, this potential Level III (79.7%), scapular pain (52.5%), anterior chest pain study provides Level IV evidence that provocative (17.8%) and headache (9.7%). Eleven patients pre- tests, including the Spurling’s test, shoulder abduc- sented with only left chest and arm pain (“cervical tion test, Valsalva and distraction test had a low sen- angina”). Pain or paresthesia in a dermatomal pat- sitivity but high specificity for cervical radiculopathy tern was reported by 53.9% of patients, while 45.5% as diagnosed by EMG. experienced pain or paresthesia in a diffuse or nondermatomal pattern. No pain or paresthesia was re- Bertilson et al11 reported a prospective case series ported by 0.6% of patients. Of patients included in analyzing the reliability of clinical tests, including the study, 85.2% reported a sensory change to pin- provocative maneuvers, in the assessment of neck prick, 68% had a specific motor deficit and 71.2% and arm pain in 100 primary care patients. Reli- had a specific decrease in a DTR. One nerve root ability of clinical tests was poor to fair in several test level was thought to be primarily responsible for categories. Only a bimanual sensitivity test reached symptoms in 87.3% of patients and two levels were good values. However, when the examiner knows felt to be equally involved for the remaining 12.7%. the clinical history, the prevalence of positive find- The correlation between pain/paresthesia, motor ings increased in 80% of test categories. Bias was ap- deficit, DTR change and the primary operative level parent in all test categories except for sensitivity. The was 73.8%, 84.8% and 83.5%, respectively. There was authors concluded that sensitivity testing was the a 71.5% incidence of correlation between preopera- most reliable and was exempt from bias. Knowledge tive clinical findings and operative findings. Good or of the patient’s history had no impact on reliability, excellent results were reported by 91.5% of patients. however it increased the incidence of positive find- Good or excellent relief of arm pain was found in ings. 95.5% of patients, neck pain in 88.8%, scapular pain in 95.9%, chest pain in 95.4% and headache In critique, patients were not enrolled at the same in 89.8%. Resolution of DTR abnormalities was re- point in their disease and there were only two reported in 96.9%. Residual sensory deficit was found viewers. Because of these limitations, this potential in 20.9% of patients and motor deficit in 2.3%. In a Level I study provides Level II evidence that history large group of patients with cervical radiculopathy, and physical findings are not definitive, that the inci- this study elucidates the common clinical findings dence of positive findings can increase with known of pain, paresthesia, motor deficit, and decreased history, and that several categories may be suscept- DTRs, along with their respective frequencies. These able to bias with a suggestive clinical history. data present evidence that the surgical site can be accurately predicted on the basis of clinical findings RECOMMENDATION: Because dermatomal 71.5% of the time. arm pain alone is not specific in identifying the pathologic level in patients with cervical In critique, no validated outcome measures were radiculopathy, further evaluation including CT, used in the study. Thus, it provides Level II evidence CT myelography, or MRI is suggested prior to that 71.5% of the time, the operative site can be ac- surgical decompression. curately predicted on the basis of clinical findings. Grade of Recommendation: B

Slipman et al46 described a prospective observation- could be correctly localized to a single level or one al study evaluating the distribution of pain and par- of two levels in 11% and 82%, respectively. Objective esthesias that result from the stimulation of specific muscle weakness corresponded to a single root or cervical nerve roots in 87 patients with 134 selective one of two roots in 77% and 12%, respectively. In all nerve root stimulations. Mechanical stimulation of cases in which C5 or C8 radiculopathy was accompa- nerve roots was carried out: four at C4, 14 at C5; 43 nied by weakness, the level was correctly localized. at C6; 52 at C7; and 21 at C8. An independent ob- Sensory loss corresponded to a single root or one of server recorded the location of provoked symptoms two roots in 65% and 35%, respectively. The authors on a pain diagram. Visual data was compiled using a concluded that clinical findings related to the fin- 793 body sector bit map with 43 body regions identi- gers are the most accurate for localizing a CDH to a fied. Although the distribution of symptom provoca- single level. A single level CDH may produce signs tion resembled the classic dermatomal maps, symp- and symptoms that correspond to overlapping der- toms were frequently provoked outside the classic matomal levels. descriptions. The authors concluded that there was a distinct difference between the dynatomal and This study provides Level II evidence that clinical dermatomal maps. This study provides Level I evi- findings related to the fingers are the most accurate dence that distribution of pain and paresthesias in for localizing a CDH to a single level. Single level the arm from nerve root stimulation can be different CDH may produce signs and symptoms that corre- from traditional dermatomal maps in a substantial spond to overlapping dermatomal levels. percentage of patients making it difficult to identify the level based on pain distribution. Future Directions for Research Further studies are needed to demonstrate the PPV Yoss et al55 conducted a retrospective observational of specific symptoms and physical exam findings in study of 100 patients to correlate clinical findings patients with confirmed cervical radiculopathy to with surgical findings when a single cervical nerve demonstrate their usefulness in predicting a good root (C5, C6, C7, C8) is compressed by a disc hernia- outcome with conservative or surgical treatment. tion. Symptoms included pain in the neck, shoulder, scapular or interscapular region, arm, forearm or History and Physical Exam Findings References hand; paresthesias in forearm, and hand; and weak- 1. Abbed KM, Coumans JV. Cervical radiculopathy: ness of upper extremity. Signs included diminution pathophysiology, presentation, and clinical evaluation. Neurosurgery. Jan 2007;60(1 Supp1 1):S28-34. of triceps, biceps and brachioradialis reflexes, mus- 2. Al-Hami S. Cervical monosegmental interbody fusion us- cle weakness and sensory loss. Pain or paresthe- ing titanium implants in degenerative, intervertebral disc sia in the neck, shoulder, scapular or interscapular disease. Minim Invasive Neurosurg. Mar 1999;42(1):10- region were present in cases of C5, C6, C7, or C8 17. compression. The presence of pain in the arm cor- 3. An HS. Cervical root entrapment. Hand Clin. Nov 1996;12(4):719-730. responded to the site compression in 23% of cases. 4. Anderberg L, Annertz M, Brandt L, Saveland H. Selec- The presence of pain or paresthesia in the forearm tive diagnostic cervical nerve root block--correlation with corresponded to a single root or one of two roots in clinical symptoms and MRI-pathology. Acta Neurochir 32% and 66%, respectively. Hand pain and paresthe- (Wien). Jun 2004;146(6):559-565; discussion 565. sia corresponded to a single root or one of two roots 5. Anderberg L, Annertz M, Rydholm U, Brandt L, Saveland H. Selective diagnostic nerve root block for the evaluation in 70% and 27%, respectively. Subjective weakness of radicular pain in the multilevel degenerated cervical corresponded to a single level in 22/34 (79%) cases. spine. Eur Spine J. Jun 2006;15(6):794-801. 6. Anderson PA, Subach BR, Riew KD. Predictors of outcome When a diminution of DTR was present, the lesion after anterior cervical discectomy and fusion: a multivariate analysis. Spine. Jan 15 2009;34(2):161-166.

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Acute low cervical nerve root conditions: symp- agement, and outcome after anterior decompressive op- tom presentations and pathobiological reasoning. Man eration in 10 patients. Neurosurgery. Mar 2006;58(3):497- Ther. May 2001;6(2):106-115. 501. 24. Goldstein B. Anatomic issues related to cervical and lum- 39. Rao R. Neck pain, cervical radiculopathy, and cervical my- bosacral radiculopathy. Phys Med Rehabil Clin N Am. Aug elopathy: Pathophysiology, natural history, and clinical 2002;13(3):423-437. evaluation. J Bone Joint Surg - Series A. 01 2002;84(10):1872-

1881. symptoms and signs in localization of involved root in cer- 40. Rao R. Neck pain, cervical radiculopathy, and cervical vical disk protrusion. Neurology. Oct 1957;7(10):673-683. myelopathy: pathophysiology, natural history, and clinical evaluation. Instr Course Lect. 2003;52:479-488. 41. Rao RD, Currier BL, Albert TJ, et al. Degenerative cervical What are the most appropriate spondylosis: clinical syndromes, pathogenesis, and management. J Bone Joint Surg Am. Jun 2007;89(6):1360-1378. diagnostic tests (including imag- 42. Rechtine GR, Bolesta MJ. Cervical radiculopathy. Semin Spine Surgery. 1999;11(4):363-372. ing and electrodiagnostics), and 43. Rubinstein SM, Pool JJM, van Tulder MW, Riphagen I, de when are these tests indicated in Vet HCW. A systematic review of the diagnostic accuracy of provocative tests of the neck for diagnosing cervical ra- the evaluation and treatment of diculopathy. Euro Spine J. Mar 2007;16(3):307-319. 44. Ruggieri PM. Cervical radiculopathy. Neuroimaging Clin cervical radiculopathy from de- N Am. 1995;5(3):349-366. 45. Shah KC, Rajshekhar V. Reliability of diagnosis of soft cer- generative disorders? vical disc prolapse using Spurling’s test. Br J Neurosurg. Oct 2004;18(5):480-483. RECOMMENDATION: MRI is suggested for the 46. Slipman CW, Plastaras CT, Palmitier RA, Huston CW, confirmation of correlative compressive lesions Sterenfeld EB. Symptom provocation of fluoroscopically guided cervical nerve root stimulation. Are dynatomal (disc herniation and spondylosis) in cervical maps identical to dermatomal maps? Spine (Phila Pa spine patients who have failed a course of 1976). Oct 15 1998;23(20):2235-2242. conservative therapy and who may be candidates 47. Tanaka Y, Kokubun S, Sato T. Mini-symposium: Cervical for interventional or surgical treatment. spine: (i) Cervical radiculopathy and its unsolved problems. Curr Orthop. Jan 1998;12(1):1-6. Grade of Recommendation: B 48. Tanaka Y, Kokubun S, Sato T, Ozawa H. Cervical roots as origin of pain in the neck or scapular regions. Spine. Aug 1 Bartlett et al9 conducted a prospective study com- 2006;31(17):E568-573. paring the accuracy of gadolinium (Gd) enhanced 49. Tong HC, Haig AJ, Yamakawa K. The Spurling test and cervical radiculopathy. Spine (Phila Pa 1976). Jan 15 MRI with 3D gradient recalled echo (3D GRE) im- 2002;27(2):156-159. ages in the evaluation of cervical radiculopathy in 50. Viikari-Juntura E, Porras M, Laasonen EM. Validity of clin- 30 consecutive patients. The 3D GRE images had an ical tests in the diagnosis of root compression in cervical accuracy of 87% for the diagnosis of foraminal en- disc disease. Spine (Phila Pa 1976). Mar 1989;14(3):253- croachment. CTM had an accuracy of 90%. MRI with 257. 51. Wainner RS, Fritz JM, Irrgang JJ, Boninger ML, Delitto A, Gd conferred no additional benefit. Oblique recon- Allison S. Reliability and diagnostic accuracy of the clinical structions were less accurate than axial images. The examination and patient self-report measures for cervical authors concluded that MRI with 3D GRE images is radiculopathy. Spine (Phila Pa 1976). Jan 1 2003;28(1):52- an acceptable technique for the primary evaluation 62. of cervical radiculopathy. CTM remains indicated 52. Wainner RS, Gill H. Diagnosis and nonoperative management of cervical radiculopathy. J Orthop Sports Phys Ther. for patients with symptoms that are incongruent Dec 2000;30(12):728-744. with MRI findings. This study provides Level II diag- 53. Waldrop MA. Diagnosis and treatment of cervical radicu- nostic evidence that MRI with 3D T2 technique has lopathy using a clinical prediction rule and a multimodal an accuracy approaching that of CT myelography intervention approach: a case series. J Orthop Sports Phys for the diagnosis of a compressive lesion in patients Ther. Mar 2006;36(3):152-159. 54. Witzmann A, Hejazi N, Krasznai L. Posterior cervical with cervical radiculopathy. foraminotomy. A follow-up study of 67 surgically treated patients with compressive radiculopathy. Neurosurg Rev. Hedberg et al22 described a retrospective compara- Dec 2000;23(4):213-217. tive study assessing the accuracy of MRI with lim- 55. Yoss RE, Corbin KB, Maccarty CS, Love JG. Significance of ited flip angle (LFA) GRE technique in patients with

cervical radiculopathy. MRI was performed in 130 that MRI is a viable alternative to myelography, and patients, myelography in 30, CTM in 16 and CT in together with CT if needed, provides a thorough five. Pathologic confirmation was obtained in 13 exam for cervical nerve root compression. surgically treated patients. MRI was normal in 31 cases and neither myelography nor surgery were Van de Kelft et al54 performed a prospective com- performed. Extradural defects were detected on parative study describing the value of MRI on a 0.5 MRI in 99/130 patients (52 central, 26 dorsolateral T system plus plain radiography in the evaluation osteophyte, 4 dorsolateral disc, 17 dorsolateral disc/ of patients with cervical radiculopathy. One hun- osteophyte). Myelography/CTM and nonenhanced dred patients with cervical radiculopathy and failed CT confirmed the abnormalities in 20 and five pa- conservative therapy were scheduled for surgery. Of tients, respectively. Surgical findings from 13 pa- these patients, 18 with myelopathy, history of sur- tients and 30 sites showed correlation with MRI on gery and history of trauma were referred for CTM 3/3 herniations and 26/27 degenerative abnormali- instead of MRI; 23 with spondylosis, major spurs, or ties. The authors concluded that MRI is sufficient for instability on plain radiography were also referred the evaluation of cervical radiculopathy and may for CTM. This excluded 41 from the potential study. obviate the need for more invasive tests such as my- In the 59 patients that underwent MRI, CDH was elography or CTM. found in 55, the location corresponding to the patients’ symptoms. Four patients without CDH were In critique, since surgical confirmation of cervical referred for CTM; a foraminal herniation was found radiculopathy was obtained for only 13 patients, the in one. Of the 55 patients with CDH, 50 underwent relevant sample size was small. Also, the study uti- surgery. In two patients, foraminal spurs were found, lized an older technique. This study provides Level not seen on MRI. MRI correlated with surgery at a III diagnostic evidence that MRI is accurate in the rate of 94%. The authors concluded that MRI com- diagnosis of disc herniation and degenerative ab- bined with plain radiography is an accurate nonin- normalities in the spine. vasive technique in the evaluation of patients with cervical radiculopathy. Modic et al34 conducted a prospective study comparing the accuracy of MRI, CTM and myelography In critique, the patients included in this study were in the evaluation of cervical radiculopathy. Of the 63 not consecutively assigned. This study provides Lev- patients enrolled in the study, 52 underwent MRI, el III diagnostic evidence that early MRI techniques myelography and CTM, and 28 underwent surgery. are reasonably accurate in diagnosing CDH in pa- Findings confirmed in surgery identified diagnostic tients with radiculopathy. This emphasizes that non- accuracy rates of 74% for MRI, 85% for CTM, and 67% invasive MRI with plain radiography can diagnose for myelography. Diagnostic agreement with surgi- specific CDH, stenosis and nerve root compression cal findings was obtained in 90% of patients when with a high degree of useful accuracy. MR and CTM were used jointly, 92% when CTM and myelography were used jointly. The authors Wilson et al61 described a retrospective comparative concluded that MRI is a viable alternative to myel- study evaluating the accuracy of MRI in the detec- ography, and together with CT if needed, provides tion of compressive lesions in patients with cervical a thorough exam of the c-spine. MRI is as sensitive, radiculopathy. Surgical diagnoses were disc hernia- but less specific, for type of disease. CTM is better at tion in 32, spondylosis in two, and a combination of distinguishing bone from disc. In critique, patients the two in six patients. MRI identified the surgical were not consecutively assigned in this small study. lesion in 37/40 patients (92%). Two independent This study provides Level III diagnostic evidence ‘reading radiologists’ knew surgery was performed,

but were blinded to the diagnosis and the level. MRI opathy and myelopathy without sufficient subgroup diagnosed an HNP at the correct location in 32/38 analysis. patients and spondylosis in two. In the six cases, in which HNP was missed, the MRI was interpreted RECOMMENDATION: CT myelography is sug- as spondylosis. In three patients MRI did not diag- gested for the evaluation of patients with clini- nose the surgical lesion. CTM was performed in 13 cal symptoms or signs that are discordant with patients, and in five of these patients CTM was felt MRI findings (eg, foraminal compression that to add additional information. There was complete may not be identified on MRI). CT myelography recovery in 31/40 patients, and incomplete recovery is also suggested in patients who have a con- in 8/40. One patient was lost to follow-up. The au- traindication to MRI. thors concluded that MRI is the only preoperative test necessary in most cases of cervical radiculop- Grade of Recommendation: B athy. The authors added that CTM might be useful in patients with a negative MRI, positive EMG and Bartlett et al9 conducted a prospective study com- neurologic deficits. In critique, the patients includ- paring the accuracy of Gd-enhanced MRI with 3D ed in this study were not consecutively assigned and GRE images in the evaluation of cervical radiculop- there was a significant dropout rate. Due to these athy in 30 consecutive patients. 3D GRE images had limitations, this potential Level II study provides an accuracy of 87% for the diagnosis of foraminal Level III diagnostic evidence that MRI is an accurate encroachment. CTM had an accuracy of 90%. MRI tool in the initial preoperative evaluation of patients with Gd conferred no additional benefit. Oblique with cervical radiculopathy. reconstructions were less accurate than axial images. The authors concluded that MRI with 3D GRE RECOMMENDATION: In the absence of reliable images is an acceptable technique for the primary evidence, it is the work group’s opinion that CT evaluation of cervical radiculopathy. CTM remains may be considered as the initial study to confirm indicated for patients with incongruent symptoms a correlative compressive lesion (disc herniation and MRI results. This study provides Level II diag- or spondylosis) in cervical spine patients who nostic evidence that MRI with 3D T2 technique has have failed a course of conservative therapy, who an accuracy approaching that of CT myelography may be candidates for interventional or surgical for the diagnosis of a compressive lesion in patients treatment and who have a contraindication to with cervical radiculopathy. MRI. Work Group Consensus Statement Houser et al24 reported a retrospective case series correlating the findings on CTM with surgical and An article by Ilkko et al26 examined the accuracy of path proven cervical herniations. Over three years, CT, myelography and MR imaging in 120 patients. 734 patients underwent CTM for cervical disc dis- Gold standard was surgery in 37 patients. The sen- ease. At surgery, CDH was noted in 297 patients. Of sitivities of CT, myelography, and MRI were 66%, the 297 patients, 280 had a diagnosis of radiculopa- 84%, and 86% however MRI was only available in 8 thy and 17 of myelopathy. Surgical reports noted patients. The accuracy of CT was degraded by beam one or more prolapsed discs in 258, a prolapsed disc hardening artifact from the shoulders in the lower and spur in 38 and a prolapsed disc with a fracture in cervical spine. The authors concluded that CT was one. CTM corresponded to surgical findings in 260 a usable alternative to MRI in selected patients. This of the 280 patients with radiculopathy and in all 17 article was excluded from the formal analysis, how- patients with myelopathy. Surgery was performed in ever, because it included patients with both radicul- 22 patients on the basis of clinical symptoms alone.

Of these 22 patients, 19 had herniations not seen Findings confirmed in surgery identified diagnostic on CTM and three had no herniations based upon accuracy rates of 74% for MRI, 85% for CTM and 67% surgical findings and CTM. A soft tissue extradural for myelography. Diagnostic agreement with surgi- deformity appeared to be present on CTM in seven cal findings was obtained in 90% of patients when patients who had no cervical abnormalities on sur- MR and CTM were used jointly, 92% when CTM gical exploration. The authors concluded that imag- and myelography were used jointly. The authors ing of CDHs continues to be difficult and the results concluded that MRI is a viable alternative to myel- are not always specific. CTM is the most sensitive ography, and together with CT if needed, provides imaging examination. In critique, patients were not a thorough exam of the c-spine. MRI is as sensitive, consecutively assigned. This study provides Level III but less specific, for type of disease. CTM is better at diagnostic evidence that CT myelography can iden- distinguishing bone from disc. In critique, patients tify 90% of cervical extruded disc herniations con- were not consecutively assigned in this small study. firmed by surgery. This study provides Level III diagnostic evidence that MRI is a viable alternative to myelography, and Houser et al25 presented a retrospective case series together with CT if needed, provides a thorough reviewing the surgical and CTM findings in 95 pa- exam of the cervical spine. tients with foraminal stenosis. CTM showed stenosis at the entrance in 70 (52%), within the canal itself Russell et al45 reported on a retrospective compara- in 37 (28%) and site not definitively identified in 27 tive study assessing the value of CT with IV contrast (20%). At the entrance to the foramen, stenosis sec- in the evaluation of patients with cervical radicu- ondary to a cartilaginous cap was identified in 10 lopathy. Ventral epidural and intervertebral veins patients (8%), osteophyte in 17 (13%), synovial cyst were consistently well visualized with CT enhanced in one and a combination of bone and cartilaginous with IV contrast. Disc protrusions were diagnosed in cap in 42 (31%). Within the canal, small bone spurs nine of 30 patients. A clear and definitive marginal arising from the uncovertebral process contributed ring blush between the disc protrusion and the en- to stenosis in 29 instances and from the facet joint hanced venous system was seen in eight of these in eight. Diagnosis on the basis of CTM was diffi- patients. Surgical confirmation was obtained in only cult because stenosis was evident as a bone spur in five of these eight patients since only five of the eight only 13% of cases, could not be distinguished from came to surgery. Visualization of posterior displace- a disc herniation in 39%, had to be distinguished ment of the enhance epidural veins and epidural from a congenitally narrowed foramen in 27% and enhancement surrounding extruded disc fragments was missed in 20%. The authors concluded that the provided excellent delineation of disc extrusion and diagnosis of foraminal stenosis on CTM is difficult. in some cases allowed demarcation of multiple dis- In critique, patients included in this study were not crete disc fragments. The authors concluded that consecutively assigned. This study provides Level III although routine CT is usually diagnostic, the addi- diagnostic evidence that there is limited correlation tion of IV contrast improves anatomic information between CT myelography and foraminal stenosis as and diagnostic certainty and may obviate the need confirmed by surgical exploration. for myelography in some patients.

Modic et al34 conducted a prospective study com- In critique, patients included in this small study paring the accuracy of MRI, CTM and myelography were not consecutively assigned. Of the nine cases in the evaluation of cervical radiculopathy. Of the 63 that reported abnormal findings, only five went on patients enrolled in the study, 52 underwent MRI, to surgery and obtained surgical confirmation. This myelography and CTM, and 28 underwent surgery. study provides Level III diagnostic evidence that the

technique of high dose contrast infusion with CT tion in 32, spondylosis in two and a combination of provides useful venous enhancement with improved the two in six patients. MRI identified the surgical visualization of the disc/epidural vein interface and lesion in 37/40 patients (92%). Two independent improved visualization of disc herniations. Myelog- ‘reading radiologists’ knew surgery was performed, raphy for cervical discs may be unnecessary unless but were blinded to the diagnosis and the level. MRI further spinal column delineation is required. diagnosed an HNP at the correct location in 32/38 patients and spondylosis in two. In the six cases in Van de Kelft et al54 performed a prospective com- which HNP was missed, the MRI was interpreted parative study describing the value of MRI on a 0.5 as spondylosis. In three patients MRI did not diag- T system plus plain radiography in the evaluation of nose the surgical lesion. CTM was performed in 13 patients with cervical radiculopathy. The study in- patients, and in five of these patients, CTM was felt cluded 100 patients with cervical radiculopathy and to add additional information. There was complete failed conservative therapy scheduled for surgery. recovery in 31/40 patients and incomplete recov- All patients underwent plain radiography. Patients ery in 8/40. One patient was lost to follow-up. The with myelopathy, history of previous surgery and authors concluded that MRI is the only preopera- history of trauma (18), and patients with spondy- tive test necessary in most cases of cervical radicu- losis, major spurs or instability on plain radiogra- lopathy. The author added that CTM may be useful phy (23) were referred for CTM. The remaining 59 in patients with a negative MRI, positive EMG and patients underwent MRI. On MRI, a soft disc her- neurologic deficits. In critique, the patients includ- niation (CDH) was found in 55 patients, the location ed in this study were not consecutively assigned and corresponding to the patients’ symptoms. The four there was a significant dropout rate. Due to these patients without CDH were referred for CTM, and limitations, this potential Level II study provides a foraminal herniation was found in one. Of the 55 Level III diagnostic evidence that MRI is an accurate patients with CDH, 50 underwent surgery. Findings tool in the initial preoperative evaluation of patients on MRI correlated with surgical findings in 94%. In with cervical radiculopathy. two patients, foraminal spurs were found, not seen on MRI. The authors concluded that MRI combined RECOMMENDATION: The evidence is insuffi- with plain radiography is an accurate noninvasive cient to make a recommendation for or against technique in the evaluation of patients with cervical the use of EMG for patients in whom the diag- radiculopathy. nosis of cervical radiculopathy is unclear after clinical exam and MRI. In critique, the patients included in this study were not consecutively assigned. This study provides Grade of Recommendation: I (Insufficient Level III diagnostic evidence that early MRI tech- Evidence) niques are reasonably accurate in diagnosing CDH in patients with radiculopathy. This emphasizes that Alrawi et al2 reported a prospective case series inves- noninvasive MRI with plain radiography can diag- tigating whether preoperative EMG can help identi- nose CDHs and nerve root compression with a high fy those most likely to benefit from intervention. The degree of useful accuracy. study included 20 patients with clinical manifestations of cervical radiculopathy and an MRI showing Wilson et al61 described a retrospective comparative disc bulges associated with narrowing of the exiting study evaluating the accuracy of MRI in the detec- foramina. Preoperatively, patients were divided into tion of compressive lesions in patients with cervical two groups on the basis of EMG findings. Group A radiculopathy. Surgical diagnoses were disc hernia- consisted of eight patients with denervation changes

in the distribution of a least one cervical nerve root. patients included in the study were not consecutive. Group B had 12 patients with no EMG evidence of This study provides Level III diagnostic evidence cervical radiculopathy. Patients in Group A had bet- that MRI is more accurate and more sensitive than ter clinical outcomes and patient satisfaction from NPS in the preoperative evaluation of patients with their ACDF at least 12 months postoperatively than cervical radiculopathy. patients in Group B. The authors concluded that preoperative neurophysiologic studies (NPS) can RECOMMENDATION: Selective nerve root help identify which patients are more likely to ben- block with specific dosing and technique efit from surgery for cervical radiculopathy. protocols may be considered in the evaluation of patients with cervical radiculopathy and In critique, patients were not consecutively assigned compressive lesions identified at multiple to the study. This study provides Level III diagnostic levels on MRI or CT myelography to discern evidence that patients with cervical radiculopathy the symptomatic level(s). Selective nerve root and an MRI showing a disc bulge with narrowing of block may also be considered to confirm a the exiting foramina have better clinical outcomes symptomatic level in patients with discordant and patient satisfaction from ACDF if a preoperative clinical symptoms and MRI or CT myelography EMG shows denervation changes. findings.

Ashkan et al6 reported on a retrospective case se- Grade of Recommendation: C ries assessing whether NPS added significant information to high resolution MRI in the evaluation of Anderberg et al4 described a prospective case series cervical radiculopathy. Of the 45 patients included assessing the use of transforaminal SNRB in pain the study, three experienced bilateral symp- tients with cervical radiculopathy and MRI findings toms. Radicular arm pain was present in all cases, at two levels ipsilateral to the patient’s symptoms. parasthesias in 28, numbness in 22 and subjective The study included 30 consecutive patients with weakness in 14. Following surgery, 36 patients had cervicobrachialgia, 22 with neurologic deficits. De- complete resolution of symptoms and seven expe- generative changes on MRI were found in close rela- rienced significant improvement in symptoms. Of tion to nerve roots. Neuroforaminal narrowing was patients who improved following surgery, 16 (37%) graded as slight, moderate or severe, without further had a positive MRI and NPS; 24 (56%) had a posi- analysis. Clinical findings were correlated with MRI tive MRI and negative NPS; two (5%) had a negative findings and root block levels were determined. No MRI and positive NPS; and one (2%) had negative analgesics were administered within 12 hours prior MRI and NPS studies. In the three cases with a nega- to the procedure, and there was no mention if seda- tive MRI, surgical plans were based on the NPS in tion was given prior to the procedure. Contrast was one case and on CTM in two. In five patients with administered to confirm perineural needle position foraminal stenosis on MRI the patients did not im- within the foramen prior to SNRB. SNRB with 0.5 ml prove. Of these five patients, four were operated on solution of 5 mg of Mepivacaine was administered. at the level indicated by MRI. Sensitivity for diag- VAS outcomes were assessed 30 minutes and four nosing cervical radiculopathy was 93% for MRI and hours after SNRB. VAS reduction of at least 50% was 42% for NPS; with PPVs at 91% for MRI and 86% for required to determine that the SNRB was positive; NPS. NPPs were 25% for MRI and 7% for NPS. The however, the authors did not indicate if this measure authors concluded that in patients with clinical and referred to the VAS score at 30 minutes or four hours MRI evidence of cervical radiculopathy, NPS has after the SNRB, or both. In 18 patients with positive limited additional diagnostic value. In critique, the SNRB at a single level, the SNRB correlated with the

level of more marked pathology in 12, to the level jectate volume. The authors concluded that only 0.6 determined by the neurologic deficits in eight and to ml injections should be used for SNRBs. This small the level corresponding to the sensory dermatome case series provides Level II diagnostic evidence in seven. Eleven patients had a positive SNRB at two that transforaminal injectate volumes of 0.6 ml con- levels. Of 13 patients treated at one level, nine (67%) sistently meet the criteria for a SNRB. had good or excellent results. Of nine patients treated at two levels, 100% had good or excellent results. Future Directions for Research The authors concluded that clinical symptoms and The work group identified the following recommen- signs in isolation or in combination with MRI find- dations that would assist in generating meaningful ings are not always reliable indicators of the pain- evidence to assist in further defining the appropri- generating nerve root. SNRB may be useful in treat- ate diagnostic tests for cervical radiculopathy from ment planning in patients with radiculopathy and degenerative disorders. Studies should assess a set degenerative changes at two levels ipsilateral to the of diagnostic criteria established a priori. patient’s symptoms. Recommendation #1: In critique, this small study did not utilize a consis- Studies evaluating the accuracy of MRI, CT and CT tently applied gold standard and surgical treatment myelography in detecting and characterizing com- or epidural steroid injection was performed in only pressive lesions in the cervical spine in patients with 22 or the 30 patients. This study provides Level III cervical radiculopathy should be repeated using diagnostic evidence that SNRB may be useful in the state of the art equipment and imaging techniques preoperative evaluation of patients with radiculopa- and should implement surgical findings and -out thy and findings of compressive lesion at multiple comes as gold standards. levels on MRI. Recommendation #2: Anderberg et al5 reviewed a prospective case series Further studies should be done to evaluate the con- of nine patients studying the selectivity of cervical tribution of EMG to the evaluation of cervical ra- transforaminal injections and the distributions of diculopathy patients with discordant MRI findings a range of injection volumes in patients with cer- and clinical findings using surgical findings and vical radiculopathy. Three groups of three patients outcomes as gold standards. received one of the following: 0.6, 1.1 or 1.7 ml of injectate via the transforaminal root technique used Recommendation #3: by Kikuchi. The groups injected with 0.6 and 1.1 ml Further studies should be done evaluating the con- received local anesthetic and contrast. The group in- tribution of SNRB to the evaluation of cervical ra- jected with 1.7 ml received local anesthetic, corticos- diculopathy patients with discordant MRI findings teroid and contrast. Contrast distribution was deter- and clinical findings, and to the evaluation of cervi- mined by a post injection CT scan. An injection was cal radiculopathy patients with findings on MRI at considered a successful SNRB if the contrast media multiple levels ipsilateral to the patient’s symptoms surrounded an adjacent nerve root by less than half using surgical findings and outcomes as gold stan- of its circumference. In all three patients receiving dards. 0.6 ml of injectate the injections were considered selective. In 2 of 3 of patients given 1.1 ml of injectate, Recommendation #4: the injections were considered selective. None of Studies should be done evaluating the contribution the three patients receiving 1.7 ml of injectate were of dynamic upright cervical spine MRI to the evalua- considered selective. The perineural distribution tion of and long term outcome of patients undergo- length averaged 36 mm, with no correlation to in- ing surgical decompression for cervical radiculopa-

This clinical guideline should not be construed as including all proper methods of care or excluding other acceptable methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding any specific procedure or treatment is to be made by the physician and patient in light of all circumstances presented by the patient and the needs and resources particular to the locality or institution. NASS Clinical Guidelines – Diagnosis and Treatment of Cervical Radiculopathy from Degenerative Disorders 28 thy with attention to the following question: Does of cervical spondylotic radiculopathy. Br J Radiol. Aug the presence of dynamic central canal stenosis at an 2003;76(908):525-531. adjacent level affect the long term outcome of pa- 14. Boden SD, McCowin PR, Davis DO, Dina TS, Mark AS, Wi- esel S. Abnormal magnetic-resonance scans of the cervi- tients undergoing surgical decompression using an cal spine in asymptomatic subjects. 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B. Outcome Measures for Medical/Interventional and Surgical Treatment

What are the most appropriate in the study, all received SNRB with mepivicaine and their arm and neck pain were assessed 30 min- outcome measures to evaluate utes following the procedure using VAS. The authors the treatment of cervical radicu- reported an 86% mean reduction in VAS arm pain scores and 65% mean reduction in VAS neck pain lopathy from degenerative disor- scores, and concluded that the VAS can be used to ders? document response to the anesthetic phase of SNRB for arm and neck pain. In critique, this study had a Asking this question about the treatment of cervi- very small sample size and the patients included cal radiculopathy from degenerative disorders is in- were not enrolled at the same point in their disease, trinsically valuable. Our review of the literature on with duration of symptoms ranging from one to 60 cervical radiculopathy from degenerative disorders months. This study provides Level II prognostic evi- confirmed that outcome studies are valuable in de- dence that the VAS pain scale can be used to docu- termining the course of treatment. ment the immediate anesthetic response to SNRB for radicular arm pain. When evaluating studies in terms of the use of out- 19 come measures, the work group evaluated this liter- Fernandez-Fairen et al reported a prospective, ran- ature as prognostic in nature. Prognostic studies in- domized controlled trial assessing the effectiveness vestigate the effect of a patient characteristic on the and safety of a tantalum implant in achieving ante- outcome of a disease. Studies investigating outcome rior cervical fusion following single level discectomy measures, by their design, are prognostic studies. as treatment for degenerative cervical disc disease with radiculopathy. Of the 61 patients included in An appropriate clinical outcome measure must be the study, 28 were treated with ACDF with interbody validated. Further, the validated outcome measure implant of tantalum and 33 received ACDF with au- must be used in a high quality, prospective outcome tologous iliac bone graft and plating. At 24 months, trial in order to be useful. The literature review yield- clinical outcomes, as assessed by the NDI, VAS pain ed no validated outcome measures utilized for the scale (arm), Odom’s criteria and Zung Depression subset of patients with cervical radiculopathy from Scale were similar for both treatment groups with- degenerative disorders. out significant difference. The authors concluded that clinical outcome as assessed by the VAS, NDI RECOMMENDATION: The Neck Disability and ZDS demonstrated that tantalum implant was Index (NDI), SF-36, SF-12 and VAS are rec- equivalent to autogenous graft and anterior plate. ommended outcome measures for assessing This study provides Level I prognostic evidence that treatment of cervical radiculopathy from de- the NDI and VAS pain scale (arm) are instruments generative disorders. that can be used to assess the outcome of surgical intervention for cervical radiculopathy from degen- Grade of Recommendation: A erative disorders. Additionally, patient satisfaction as measured by Odom’s criteria and depression as Anderberg et al2 described a prospective observa- assessed by the ZDS appear useful. tional study examining the correlation between 22 SNRB and MRI findings and clinical symptoms. Of Foley et al conducted a prospective randomized the twenty consecutively assigned patients included controlled trial to determine the efficacy and safety

of pulsed electromagnetic field stimulation as an II evidence that NDI, VAS and SF-36 can be used to adjunct to arthrodesis after ACDF in patients with assess outcome of interventional treatment of cervi- potential risk factors for nonunion. Of the 323 con- cal radiculopathy from degenerative disorders. secutively assigned patients, 163 received PEMF in addition to the ACDF. Clinical outcomes as assessed Lofgren et al41 conducted a prospective observational by the NDI, VAS (arm) and SF-12 demonstrated that study to compare the clinical outcome after surgery there were no significant differences between the for cervical radiculopathy from degenerative disor- two treatments. Because less than 80% of patients ders to conservative treatment. Forty-three surgical were available at 12 month follow-up, this study pro- patients were studied prospectively and received vides Level II evidence NDI, VAS (arm) and SF-12 ACDF (Cloward, single level). Their outcomes were can be used to assess outcome after surgical inter- compared with a control group of 39 patients (two vention for cervical radiculopathy from degenera- did have surgery) who were treated conservatively. tive disorders. The conservative treatment protocol was not described. Outcomes were assessed at three months, Hacker et al25 described a randomized controlled tri- six months, nine months and two years. Pain reduc- al to report clinical results with maximum 24 month tion measured with the VAS (arm) was more pro- follow-up of fusions performed with the BAK/C fu- nounced among the surgically treated patients at sion cage. Of the 344 patients available at 12 month the final follow-up for maximal neck pain (p=0.03) follow-up, 245 had been assigned to the BAK/C fu- and at three months and nine months, respectively, sion cage groups and 105 were assigned to the con- for average neck pain (p=0.02, both). Initially there trol group. Clinical outcome as assessed with the VAS was no statistically significant difference in pain in- and SF-36 showed that there were similar outcomes tensity between the surgically and conservatively between the ACDF group and the BAK/C group at treated groups. Sickness Impact Profile showed that 12 months and 24 months. The authors concluded patients scheduled for surgery had higher sickness that clinical outcomes after a cervical fusion with impact in the overall index. The authors concluded a threaded cage are the same as those of a conven- that surgically treated patinets demonstrated an im- tional uninstrumented bone-only ACDF. This study provement in VAS (arm) pain and SIP scores, as well provides Level I evidence that the VAS and SF-36 as at the clinical examination, all indicating a true can be used to assess outcome following surgery for improvement, although only partially maintained. cervical radiculopathy from degenerative disorders. This study provides Level I evidence that VAS (arm) may be a useful surgical outcome measure for pa- Kumar et al38 reported on a retrospective observa- tients with cervical radiculopathy from degenerative tional study designed to highlight the effectiveness disorders. and safety of cervical selective nerve root block (SNRB) using a two needle technique for treatment Mummaneni et al43 reported findings of a prospec- of radiculopathy. Although the 33 patients included tive randomized controlled trial comparing the re- in the study were followed for two years, clinical out- sults of cervical disc arthroplasty to ACDF. Of the 541 comes were reported only for the first year. Statisti- patients included in the study, 276 received a Pres- cal improvements in VAS and NDI scores were seen tige disc and 265 were treated with ACDF and plat- at six weeks and 12 months following the procedure. ing. Outcomes were assessed at 1.5 months, three The authors concluded that the VAS and NDI can be months, six months, 12 months and 24 months. used to show that the two needle technique of cervi- Neck pain, arm pain and NDI scores were improved cal foraminal SNRB produces improved outcomes at in the Prestige disc group, with statistically superior six weeks and 12 months. This study provides Level success rates at 12 and 24 months compared with

the control group. Neck pain improved in both treat- Nunley et al46 conducted a prospective random- ment groups, but statistically significant improve- ized controlled trial comparing the clinical and ra- ments were noted in the Prestige group at six weeks, diographic outcomes of patients treated with one- three months and 12 months. No significant inter- level or multiple level ACDF using cervical plates group differences in arm pain or return to work were of dynamic/slotted vs. static/fixed hole design. Of noted at 24 months. The NDI score was statistically the 66 patients included in the study and treated significantly higher only at three months, but tend- with ACDF, 33 received static plates and 33 received ed to have higher scores than the control group. The dynamic plates. VAS and NDI score were lower in authors concluded that the Prestige ST-cervical disc patients with dynamic plates than static plates. At system maintained physiological segmental motion mean follow-up of 16 months, 49 patients (73.7%) at 24 months after implanation and was associated had clinical success and 56 (85%) showed radio- with improved neurologic success, improved clini- graphic fusion. In single-level fusion, no statistical cal outcomes (SF-36) and reduced rate of secondary difference of outcome was observed between the surgeries compared to ACDF. In critique, this study two groups, but multilevel fusions with dynamic had a 75% follow-up in the control group and pro- plate showed significantly lower VAS and NDI scores vides Level II evidence that NDI and SF-36 can be than those with static plates (ρ=0.050). The authors used to assess the outcomes of cervical radiculpa- concluded that SF-36 and NDI scores were better in thy treated by discectomy and articifial disc replace- patients with dynamic plates as compared to those ment or fusion. with static plates. They stated that clinical improvement is a good predictor of successful ACDF and that Murrey et al45 described a prospective randomized radiologic evidence of fusion alone is not reliable as controlled trial comparing the safety and efficacy of a parameter of success. Plate design for single-level C-TDR with ProDisc-C to ACDF for the treatment of fusion does not affect outcomes, but outcome stud- a symptomatic cervical disc at one level between C3 ies indicate that multilevel fusions may have better and C7. Of the 209 patients included in the study, 103 clinical outcomes when dynamic/slotted plates are received ProDisc-C TDR and 106 were treated with used. This study provides Level I evidence that NDI single level ACDF. Outcomes were assessed at three and VAS are outcome measures that can be used to months, six months, 12 months, 18 months and 24 assess cervical radiculopathy from degenerative dis- months. NDI and SF-36 improved in both groups orders. as compared to preoperative scores (ρ<0.0001). VAS neck and arm pain intensity and frequency Park et al49 described a retrospective case control were statistically lower at all follow-up time points study comparing the clinical and radiographic out- compared with preoperatively (ρ<0.0001) but were comes of CDR-Mobi-C to ADV-Solis cage. Of the 53 no different between treatment groups. Authors patients included in the study, 21 were treated with concluded that neurologic success (improvement CDR-Mobi-C and 32 received ADF-Solis-cage. Out- or maintenance) as determined by NDI, SF-36 and comes were assessed at six weeks, three months, six VAS neck and arm pain scores was seen in 90.9% of months and 12 months. Mean hospital stay and in- ProDisc-C and 88% of fusion patients (ρ=0.638) at terval between surgery and return to work were sig- 24 months. Fusion patients had a higher secondary nificantly shorter in the arthroplasty group than the surgery rate and higher medication usage postop- fusion group. Mean NDI and extremity VAS score eratively. This study provides Level I evidence that improved after 12 months in both groups. Although NDI, SF-36 and VAS are outcome tools that can be it was not significant, segmental range of motion used to assess cervical disc disease, including cervi- (ROM) at adjacent levels was higher in the fusion cal radiculopathy, following surgery. group than the arthroplasty group. Segmental mo-

tion at the operative level in the arthroplasty group outcome than were baseline values. NDI was not maintained more motion than preoperative values only overall the most important factor in explain- at final follow-up. The authors concluded that clini- ing short- and long-term outcomes, but also was cal outcomes were similar in both groups. Mean NDI the factor with the highest impact explaining the and extremity VAS scores improved after 12 months total prediction model. NDI may be regarded as an in both groups. In critique, this study had a small important outcome measurement in evaluation of sample size and the authors did not adequately ex- ACDF. This study provides Level I evidence that NDI plain how assignments to the two treatment groups and VAS are good outcome measures to assess cer- were made. The two groups were not appropriately vical radiculopathy from degenerative disorders. matched; the fusion group had more males, iliac crest graft was only performed in the fusion group Xie et al65 performed a prospective randomized and the fusion group had cervical orthosis for two controlled trial to determine the clinical outcome months. Due to these limitations, this potential of ACD, ACDF and anterior cervical discectomy Level II study provides Level III evidence that NDI and fusion with instrumentation (ACDFI). Of the and VAS may be appropriate outcome measures to 45 patients included in the study, 15 were assigned assess cervical radiculopathy from degenerative dis- to each treatment group. Outcomes were asessed at orders. three weeks, six weeks, three months, six months, one year and two years. SF-36 scores demonstrated Peolsson et al51 conducted a prospective random- a dynamic postoperative improvement followed by ized controlled trial to determine the predictive fac- further gradual improvement in both physical and tors for short-term and long-term outcome of ACDF mental components as well as other subscale scores using VAS and NDI multivariate analysis. Of the in all groups during the follow-up period (ρ<0.05). 103 consecutively assigned patients included in the The amount of pain demonstrated by the McGill study, 95 proceeded with surgical treatment. Of the pain rating index scores significantly decreased for 95 surgically treated patients, 52 received a cervical all three groups immediately after surgery and con- intervertebral fusion cage and 51 received a Cloward tinued to decline, plateauing at about one year. The procedure. Outcomes were assessed at 12 months authors concluded that SF-36 scores improved in and 24 months and compared with preoperative all three groups during the follow-up period, and data. Using multivariate analysis, the variables’ in- McGill pain scores markedly improved immediately fluence on projection showed that the most impor- after surgery and continued to improve until the one tant preoperative variables for predicting short-term year follow-up evaluation before plateauing. In cri- NDI and pain intensity were: NDI, horizontal active tique, neither patients nor reviewers were masked range of motion (AROM), pain intensity, smoking, to treatment group and the sample size was small. right hand strength, gender and kyphosis. Radio- Three of the 45 patients were lost to follow-up. Pa- logical finding and surgical technique except pre- tients included in the study were enrolled at differ- operative kyphosis were insignificant as predictors ent points in their disease and received surgery at of both short- and long-term outcome. The authors single and multiple levels. Due to these limitations, concluded that a preoperative low neck specific dis- this potential Level I study provides Level II evidence ability, low pain intensity, nonsmoking status, male that SF-36 may be an appropriate outcome tool for gender, good preoperative hand strength and neck cervical radiculopathy from degenerative disorders AROM were significant predictors for a good long- treated with surgery. term outcome of pain intensity and NDI after ACDF. Short-term outcome measures of NDI and pain Zoega et al65 described a prospective observation- intensity were better predictors of the long-term al study of patients undergoing ACDF or ACDFI at

single or multiple levels to determine the usefulness EMG evidence of nerve root involvement, while 12 of outcome scores in the treatment of degenerative did not. Patient outcomes at minimum of 12 months disc disease. Of the 46 patients included in the study, as measured with a modified Prolo scale were bet- 12 received single-level ACDF, 10 received two-level ter predicted by EMG. The authors concluded that ACDF, 15 received single-level ACDFI and 9 received EMG can better predict outcomes as measured by two-level ACDFI. At two years, 81% of patients were a modified Prolo scale. In critique, this study had a satisfied with the outcome of surgery. All scores im- very small sample size of nonrandomized patients proved in the group operated on at two-levels. VAS who were enrolled at different points of their - dis arm and neck pain decreased in both groups. The ease. Patients still received an operation even if they improvement in arm pain was significantly more had a negative EMG. Due to these limitations, this pronounced in patients operated with a plate at two- study provides Level III evidence that the modified levels compared to those who were operated with- Prolo scale can be used to assess patient outcome out a plate. At two year follow-up, patients with an after ACDF. excellent or good result according to Odom’s criteria had a lower Million Index (ρ<0.0005), Oswestry In- Cleland et al15 described a prospective observational dex (ρ<0.0005) and Zung Depression Scale (ρ=0.024) study examining the test-retest reliability, construct score than the group classified as fair or poor. There validity and minimum levels of detectable and clini- was a significant correlation ρ( <0.0001) for all scores cally important change for the NDI and PSFS in a between the test and retest. The authors concluded cohort of patients with cervical radiculopathy. All that Modified Million Index and Oswestry Index are 38 patients included in the study received physical clinically useful tools in the evaluation of outcome therapy and were assessed at a mean of 21.5 days. after degenerative cervical disc disease surgery. The Test-retest reliability was moderate for the NDI and outcome after surgery measured with the Oswestry high for the PSFS. The PSFS was more responsive to Index, Modified Million Index, and VAS neck and change than the NDI. The minimal detectable change arm pain seem to correlate well with the classifica- for the NDI was 10.2 and for the PSFS was 2.1. The tion of outcome by Odom. This study provides Level authors concluded that the PSFS exhibits superior II evidence that VAS may be an appropriate outcome reliability, construct validity, and responsiveness in measure for cervical radiculopathy from degenera- this cohort of patients with cervical radiculopathy tive disorders treated with surgery. compared with the NDI. This study provides Level I evidence that the PSFS may be better than the NDI RECOMMENDATION: The Modified Prolo, Pa- for the assessment of outcomes in patients with cer- tient Specific Functional Scale (PSFS), Health vical radiculopathy. Status Questionnaire, Sickness Impact Profile, Modified Million Index, McGill Pain Scores and Davis et al17 conducted a retrospective observa- Modified Oswestry Disability Index are suggest- tional study assessing the outcome of posterior de- ed outcome measures for assessing treatment compression for cervical radiculopathy. Of the 170 of cervical radiculopathy from degenerative dis- patients included in the study, patients who had orders. sedentary occupations and housewives had signifi- GRADE OF RECOMMENDATION: B cantly higher Prolo scores (p<0.001) than those who did strenuous work. In 86% of patients, outcome was Alrawi et al1 reported the findings of a prospective good (defined as a Prolo score of 8 in 5%, 9 in 38% observational study examining the utility of neuro- and 10 in 43%). The authors concluded that although physiological EMG to predict outcome after ACDF. outcome studies must have subjective criteria, the Of the 20 patients included in the study, eight showed Prolo scale is more objective and quantitative than

currently used methods. This study provides Level impact in the overall index. The authors concluded II evidence that the author’s modified Prolo scale that surgically treated patients demonstrated an im- may be reasonable to assess outcomes for cervical provement in VAS (arm) pain and SIP scores, as well radiculopathy from degenerative disorders. as at the clinical examination, all indicating a true improvement, although only partially maintained. Klein et al34 reported results from a prospective ob- This study provides Level I evidence that SIP may be servational study assessing patient outcomes using a useful surgical outcome measure for patients with the Health Status Questionnaire after one- or two- cervical radiculopathy from degenerative disorders. level ACDF. In the 28 patients included in the study, statistically significant improvements were found Witzmann et al64 described a retrospective observa- in postoperative scores for bodily pain (p<0.001), tional study designed to determine the clinical and vitality (p=0.003), physical function (p=0.01), role economic outcome of patients undergoing posteri- function/physical (p=0.0003) and social function or cervical foraminotomy for the treatment of com- (p=0.0004). No significant differences were found pressive radiculopathy. At mean follow-up of 3.1 for three health scales: general health, mental years, VAS scores indicated 93% of the 67 patients health and role function associated with emotional included in the study were improved. Prolo scores limitations. Authors concluded that the HSQ may be indicated 90% of patients had an excellent economic a good disease specific outcome tool for one- and outcome and 79% of patients returned to their prior two-level ACDF. This small study provides Level II employment. In critique, patients were enrolled at evidence that the HSQ may be a good outcome mea- different points in their disease with 57 single-level sure for assessing treatment of cervical radiculopa- surgeries and 10 multiple level surgeries. Less than thy from degenerative disorders. 80% of patients were available for follow-up. Due to these limitations, this potential Level II study pro- Lofgren et al41 conducted a prospective observa- vides Level III evidence that the Prolo scale may be tional study to follow the clinical outcome after an appropriate outcome measure to assess surgical surgery for cervical radiculopathy from degenera- treatment results for cervical radiculopathy from tive disorders and to compare it with the outcome degenerative disorders. after conservative treatment. Forty-three surgical patients were studied prospectively and received Xie et al65 performed a prospective randomized ACDF (Cloward-single level). Their outcomes were controlled trial to determine the clinical outcome of compared with a control group of 39 patients (two ACD, ACDF and ACDFI. Of the 45 patients includ- did have surgery) who were treated conservatively. ed in the study, 15 were assigned to each treatment The conservative treatment protocol was not de- group. Outcomes were asessed at three weeks, six scribed. Outcomes were assessed at three months, weeks, three months, six months, one year and two six months, nine months and two years. Pain reduc- years. SF-36 scores demonstrated a dynamic post- tion measured with the VAS (arm) was more pro- operative improvement followed by further gradual nounced among the surgically treated patients at improvement in both physical and mental compo- the final follow-up for maximal neck pain (p=0.03) nents as well as other subscale scores in all groups and at three months and nine months, respectively, during the follow-up period (ρ<0.05). The amount of for average neck pain (p=0.02, both). Initially there pain demonstrated by the McGill pain scores signif- was no statistically significant difference in pain in- icantly decreased for all three groups immediately tensity between the surgically and conservatively after surgery and continued to decline, plateauing treated groups. Sickness Impact Profile showed that at about one year. The authors concluded that SF- patients scheduled for surgery had higher sickness 36 scores improved in all three groups during the

follow-up period. McGill pain scores markedly im- Modified Oswestry Disability Index may be appro- proved immediately after surgery and continued priate outcome measures for cervical radiculopathy to improve until the one year follow-up evaluation from degenerative disorders treated with surgery. before plateauing. In critique, neither patients nor reviewers were masked to treatment group and the Future Directions for Research sample size was small. Three of the 45 patients were Disease specific outcome measures like the PSFS lost to follow-up. Patients included in the study were and the HSQ have been developed and seem to be enrolled at different points in their disease and re- useful in assessing outcome for the treatment of ceived surgery at single and multiple levels. Due to cervical radiculopathy from degenerative disorders. these limitations, this potential Level I study pro- These measures are limited in that they have not vides Level II evidence that the McGill pain scores been widely used or accepted. Outcome measures may be an appropriate outcome tool for cervical such as these need to be incorporated into Level I radiculopathy from degenerative disorders treated studies to confirm their validity and to establish with surgery. themselves as acceptable research tools to quanti- tate outcome after cervical radiculopathy from de- Zoega et al65 described a prospective observation- generative disorders. al study of patients undergoing ACDF or ACDFI at single or multiple levels to determine the usefulness References of outcome scores in the treatment of degenerative 1. Alrawi MF, Khalil NM, Mitchell P, Hughes SP. The value of disc disease. Of the 46 patients included in the study, neurophysiological and imaging studies in predicting outcome in the surgical treatment of cervical radiculopathy. 12 received single-level ACDF, 10 received two-level Eur Spine J. Apr 2007;16(4):495-500. ACDF, 15 received single-level ACDFI and 9 received 2. Anderberg L, Annertz M, Brandt L, Saveland H. Selec- two-level ACDFI. At two years, 81% of patients were tive diagnostic cervical nerve root block--correlation with satisfied with the outcome of surgery. All scores im- clinical symptoms and MRI-pathology. Acta Neurochir proved in the group operated on at two-levels. VAS (Wien). Jun 2004;146(6):559-565; discussion 565. 3. Anderson PA, Subach BR, Riew KD. Predictors of outcome arm and neck pain decreased in both groups. The after anterior cervical discectomy and fusion: a multivari- improvement in arm pain was significantly more ate analysis. Spine. Jan 15 2009;34(2):161-166. pronounced in patients operated with a plate at two- 4. Andrews NB, Lawson HL, Odjidja TL. Elective non-instru- levels compared to those who were operated with- mented anterior cervical diskectomy and fusion in Ghana: out a plate. At two year follow-up, patients with an a preliminary report. West Afr J Med. Jun 2003;22(2):128- 132. excellent or good result according to Odom’s criteria 5. Arnold P, Boswell S, McMahon J. Threaded interbody fu- had a lower Million Index (ρ<0.0005), Oswestry In- sion cage for adjacent segment degenerative disease af- dex (ρ<0.0005) and Zung Depression Scale (ρ=0.024) ter previous anterior cervical fusion. Surg Neurol. Oct score than the group classified as fair or poor. There 2008;70(4):390-397. was a significant correlation ρ( <0.0001) for all scores 6. Balasubramanian C, Price R, Brydon H. Anterior cervical microforaminotomy for cervical radiculopathy--results between the test and retest. The authors concluded and review. Minim Invasive Neurosurg. Oct 2008;51(5):258- that Modified Million Index and Oswestry Index are 262. clinically useful tools in the evaluation of outcome 7. Boehm H, Greiner-Perth R, El-Saghir H, Allam Y. A new after degenerative cervical disc disease surgery. The minimally invasive posterior approach for the treat- outcome after surgery measured with the Oswestry ment of cervical radiculopathy and myelopathy: surgical technique and preliminary results. Eur Spine J. Jun Index, Modified Million Index, and VAS neck and 2003;12(3):268-273. arm pain seem to correlate well with the classifica- 8. Bolton JE, Humphreys BK. The Bournemouth Question- tion of outcome by Odom. This study provides Lev- naire: a short-form comprehensive outcome measure. II. el II evidence that the Modified Million Index and Psychometric properties in neck pain patients. J Manipu- lative Physiol Ther. Mar-Apr 2002;25(3):141-148.

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C. Medical and Interventional Treatment What is the role of pharmacologi- What is the role of physical ther- cal treatment in the management apy/exercise in the treatment of of cervical radiculopathy from de- cervical radiculopathy from degenerative disorders? generative disorders?

A systematic review of the literature yielded no stud- A systematic review of the literature yielded no studies to adequately address the role of pharmacologi- ies to adequately address the role of physical thera- cal treatment in the management of cervical radicu- py/exercise in the management of cervical radicul- lopathy from degenerative disorders. opathy from degenerative disorders.

Future Directions for Research RECOMMENDATION: Emotional and cognitive The work group identified the following suggestions factors (eg, job dissatisfaction) should be consid- for future studies which would generate meaning- ered when addressing surgical or medical/inter- ful evidence to assist in further defining the role of ventional treatment for patients with cervical pharmacological treatment in the management of radiculopathy from degenerative disorders. cervical radiculopathy from degenerative disorders. GRADE OF RECOMMENDATION: Recommendation #1: I (Insufficient Evidence) Future studies of the effects of pharmacological treatment in the management of cervical radiculop- Persson et al6 conducted a prospective randomized athy from degenerative disorders should include an controlled trial comparing coping strategies, pain untreated control group when ethically possible. and emotional relationships of patients with cervical radiculopathy of at least three months duration Recommendation #2: randomly assigned to one of three treatment groups. Future outcome studies including patients with cervi- Of the 81 patients included in the study, 27 were as- cal radiculopathy from degenerative disorders treated signed to cervical bracing, 27 to physical therapy and only with pharmacological treatment should include 27 to ACDF (Cloward technique). Three patients as- subgroup analysis for this patient population. signed to the surgical group refused the procedure and were handled in intent to treat analysis. In the surgical group, eight patients had a second opera- Pharmacological Treatment References tion: six on adjacent level, one infection and one 1. Peloso Paul Michael J, Gross A, Haines T, et al. Medicinal plexus exploration. Eleven patients in the surgery and injection therapies for mechanical neck disorders. group also received physical therapy. One patient Cochrane Database of Systematic Reviews. 2007. 2. Saal JS, Saal JA, Yurth EF. Nonoperative management of in the physical therapy group and five in the collar herniated cervical intervertebral disc with radiculopathy. group had surgery with Cloward technique. Spine. Aug 15 1996;21(16):1877-1883. 3. Verbiest H. Chapter 23. The management of cervical spon- Chronic symptoms influenced both function and dylosis. Clin Neurosurg. 1973;20:262-294. mental well being such as emotional state, level of

anxiety, depression, sleep and coping behavior. Pain was the most important primary stressor. Surgery reduced the pain faster, but no difference was seen

after 12 months. Reoperation rate was 29%, mostly of behavioral and emotional dysfunction in cervical for adjacent segment disease. The low positive mood radiculopathy patients. Medical/interventional and state (MACL score) did not improve over time. Pa- surgical treatment must include a cognitive, behav- tients who still had pain after treatment were more ioral component for either method to be successful. socially withdrawn and ceased to express their emotions. The Hospital Anxiety and Depression (HAD) Future Directions for Research anxiety score was especially high in patients before The work group identified the following suggestions and after treatment. In patients with high pain inten- for future studies which would generate meaning- sity, low function, high depression and anxiety were ful evidence to assist in further defining the role of seen. The group treated with surgery showed more physical therapy/exercise in the management of anxiety and depression if pain continued, implying cervical radiculopathy from degenerative disorders. higher expectations and more disappointment if it failed. The strongest correlation between depression Recommendation #1: and pain was seen in the collar group, possibly be- Future studies of the effects of physical therapy/ex- cause they received less attention overall. In gener- ercise in the management of cervical radiculopathy al, coping strategies changed. Active coping (cogni- from degenerative disorders should include an un- tive reappraisal and problem solving) was common treated control group when ethically possible. before treatment, but disappeared after treatment, especially in the surgical group. Coping with pain Recommendation #2: was changed in general into a more passive/escape Future outcome studies including patients with focused strategy. It appeared that with intervention, cervical radiculopathy from degenerative disorders especially surgery, healthy active coping strategies treated only with physical therapy/exercise should tended to be replaced by passive coping strategies include subgroup analysis for this patient popula- as patients allowed themselves to become more de- tion. pendent on the intervention. This also implied that the ability for active coping was present before in- Recommendation #3: tervention, and thus cognitive behavioral treatment Future studies evaluating the effects of emotional, started concurrently with other interventions may cognitive and work-related issues would add to our be particularly successful for maintaining better understanding of how these factors affect outcomes coping patterns. Function was significantly related in patients with cervical radiculopathy from degen- to pain intensity. About 40% had anxiety only par- erative disorders. tially connected to pain. Prior to treatment, 30% of patients were depressed. After 12 months, 20% suf- Physical Therapy/Exercise References fered from depression. The authors concluded that 1. Lipetz JS, Misra N, Silber JS. Resolution of pronounced cognitive and behavioral therapy is important to painless weakness arising from radiculopathy and disk extrusion. Am J Phys Med Rehabil. Jul 2005;84(7):528-537. include in multidisciplinary rehabilitation. Patients 2. McClure P. The degenerative cervical spine: pathogen- need to improve coping strategies, self image and esis and rehabilitation concepts. J Hand Ther. Apr-Jun mood. 2000;13(2):163-174. 3. McCormack BM, Weinstein PR. Cervical spondylosis. An In critique, neither patients nor reviewers were update. West J Med. Jul-Aug 1996;165(1-2):43-51. 4. Murphy DR, Beres JL. Is treatment in extension contrain- masked to treatment group, the sample size was dicated in the presence of cervical spinal cord compres- small and duration of follow-up was short. Due to sion without myelopathy? A case report. Man Ther. Oct these limitations, this potential Level I study pro- 2008;13(5):468-472. vides Level II evidence that there is a high incidence 5. Murphy DR, Hurwitz EL, Gregory A, Clary R. A nonsurgical approach to the management of patients with cervical

radiculopathy: A prospective observational cohort study. known, careful consideration should be given J Manipulative Physiol Ther. May 2006;29(4):279-287. to evidence suggesting that manipulation may 6. Persson LC, Lilja A. Pain, coping, emotional state and lead to worsened symptoms or significant com- physical function in patients with chronic radicular neck pain. A comparison between patients treated with surgery, plications when considering this therapy. Pre- physiotherapy or neck collar--a blinded, prospective ran- manipulation imaging may reduce the risk of domized study. Disabil Rehabil. May 20 2001;23(8):325- complications. 335. Work Group Consensus Statement 7. Rosomoff HL, Fishbain D, Rosomoff RS. Chronic cervical pain: radiculopathy or brachialgia. Noninterventional treatment. Spine. Oct 1992;17(10 Suppl):S362-366. Future Directions for Research 8. Saal JS, Saal JA, Yurth EF. Nonoperative management of The work group identified the following suggestions herniated cervical intervertebral disc with radiculopathy. for future studies which would generate meaning- Spine. Aug 15 1996;21(16):1877-1883. ful evidence to assist in further defining the role of 9. Waldrop MA. Diagnosis and treatment of cervical radicu- manipulation/chiropractics in the management of lopathy using a clinical prediction rule and a multimodal intervention approach: a case series. J Orthop Sports Phys cervical radiculopathy from degenerative disorders. Ther. Mar 2006;36(3):152-159. Recommendation #1: Future studies of the effects of manipulation/chiro- What is the role of manipulation/ practics in the management of cervical radiculopa- chiropractics in the treatment of thy from degenerative disorders should include an cervical radiculopathy from de- untreated control group when ethically possible. generative disorders? Recommendation #2: Future outcome studies including patients with A systematic review of the literature yielded no stud- cervical radiculopathy from degenerative disor- ies to adequately address the role of manipulation/ ders treated only with manipulation/chiropractics chiropractics in the management of cervical radicu- should include subgroup analysis for this patient lopathy from degenerative disorders. The review did population. identify several case reports and series describing serious vascular and nonvascular complications Recommendation #3: and adverse outcomes associated with manipula- Future studies of the effects of manipulation/chiro- tion including radiculopathy, myelopathy, disc her- practics in the management of cervical radiculopa- niation and vertebral artery compression.9,13,14,17 The thy from degenerative disorders should include data true incidence of such complications is unknown and discussion about any complications associated and estimates vary widely. Some complications with treatment. have occurred in patients with previously unrecog- nized spinal metastatic disease who did not have Manipulation/Chiropractics References premanipulation imaging. Most patients with seri- 1. Brouillette DL, Gurske DT. Chiropractic treatment of cer- ous complications of manipulation require emer- vical radiculopathy caused by a herniated cervical disc. J Manipulative Physiol Ther. Feb 1994;17(2):119-123. gent surgical treatment. 2. Eriksen K. Management of cervical disc herniation with upper cervical chiropractic care. J Manipulative Physiol Ther. Jan 1998;21(1):51-56. RECOMMENDATION: As the efficacy of ma- 3. Gudavalli S, Kruse RA. Foraminal stenosis with radiculop- nipulation in the treatment of cervical radicu- athy from a cervical disc herniation in a 33-year-old man treated with flexion distraction decompression manipula- lopathy from degenerative disorders is un- tion. J Manipulative Physiol Ther.Jun 2008;31(5):376-380.

4. Haneline MT, Lewkovich G. Malone D G, Baldwin N G, intervention approach: a case series. J Orthop Sports Phys Tomecek F J, et al: Complications of cervical spine ma- Ther. Mar 2006;36(3):152-159. nipulation therapy: 5-year retrospective study in a single-group practice. Neurosurg Focus. 13(6):Clinical Pearl, 2002. Neurosurg Focus. Mar 15 2003;14(3):e10; author re- What is the role of epidural ste- ply e10. 5. Heckmann JG, Lang CJ, Zobelein I, Laumer R, Druschky roid injections for the treatment A, Neundorfer B. Herniated cervical intervertebral discs with radiculopathy: an outcome study of conserva- of cervical radiculopathy from tively or surgically treated patients. J Spinal Disord. Oct degenerative disorders? 1999;12(5):396-401. 6. Herzog J. Use of cervical spine manipulation under anesthesia for management of cervical disk herniation, cer- A systematic review of the literature revealed limited vical radiculopathy, and associated cervicogenic head- high quality studies to address this question. There ache syndrome. J Manipulative Physiol Ther. Mar-Apr is Level IV data indicating that transforaminal epi- 1999;22(3):166-170. dural steroid injections may provide relief for 60% 7. Hubka MJ, Phelan SP, Delaney PM, Robertson VL. Rotary manipulation for cervical radiculopathy: observations on of patients, and about 25% of patients referred with the importance of the direction of the thrust. J Manipula- clear surgical indications may obtain at least short- tive Physiol Ther. Nov-Dec 1997;20(9):622-627. term pain relief negating the need for surgery. Inter- 8. Kruse RA, Imbarlina F, De Bono VF. Treatment of cervi- estingly, there is limited Level II evidence that sug- cal radiculopathy with flexion distraction. J Manipulative gests that the addition of steroid to local anesthetic Physiol Ther. Mar-Apr 2001;24(3):206-209. 9. Malone DG, Baldwin NG, Tomecek FJ, et al. Complications does not improve pain relief in these patients at three of cervical spine manipulation therapy: 5-year retrospec- weeks post-injection. All of the studies that qualified tive study in a single-group practice. Neurosurg Focus. Dec as at least Level IV data used transforaminal epidu- 15 2002;13(6):ecp1. ral injections under fluoroscopic or CT guidance as 10. Murphy DR. Herniated disc with radiculopathy following the method of treatment. For this reason, the work cervical manipulation: nonsurgical management. Spine J. Jul-Aug 2006;6(4):459-463. group was unable to make recommendations re- 11. Murphy DR, Beres JL. Cervical myelopathy: a case report garding the safety or efficacy of interlaminar epi- of a “near-miss” complication to cervical manipulation. J dural steroid injections for the treatment of cervical Manipulative Physiol Ther. Sep 2008;31(7):553-557. radiculopathy. 12. Murphy DR, Beres JL. Is treatment in extension contrain- dicated in the presence of cervical spinal cord compression without myelopathy? A case report. Man Ther. Oct The literature search yielded a number of publica- 2008;13(5):468-472. tions demonstrating that transforaminal epidural 13. Oppenheim JS, Spitzer DE, Segal DH. Nonvascular com- steroid injections are not without risk and the po- plications following spinal manipulation. Spine J. Nov tential complications, including spinal cord injury 2005;5(6):660-666. and death, need to be considered before performing 14. Padua L, Padua R, LoMonaco M, Tonali PA. Radiculom- 20,25 edullary complications of cervical spinal manipulation. this procedure. Spinal Cord. Aug 1996;34(8):488-492. 15. Pollard H, Tuchin P. Cervical radiculopathy: a case for RECOMMENDATION: Transforaminal epidu- ancillary therapies? J Manipulative Physiol Ther. May ral steroid injections using fluoroscopic or CT 1995;18(4):244-249. guidance may be considered when developing 16. Saal JS, Saal JA, Yurth EF. Nonoperative management of herniated cervical intervertebral disc with radiculopathy. a medical/interventional treatment plan for pa- Spine. Aug 15 1996;21(16):1877-1883. tients with cervical radiculopathy from degen- 17. Tseng SH, Lin SM, Chen Y, Wang CH. Ruptured cervical erative disorders. Due consideration should be disc after spinal manipulation therapy: report of two cas- given to the potential complications. es. Spine. Feb 1 2002;27(3):E80-82. 18. Waldrop MA. Diagnosis and treatment of cervical radiculopathy using a clinical prediction rule and a multimodal GRADE OF RECOMMENDATION: C

Cyteval et al10 described a prospective case series transforaminal epidural steroid injections and were of 30 patients treated with transforaminal epidural followed until they obtained satisfactory relief or steroid injections under CT guidance. At six month underwent surgical management. Of these patients, follow-up 60% of patients obtained good or excel- 65% (45/70) reported good or excellent results with lent pain relief. In critique of this study, this is a regard to pain relief and 63% (44/70) opted not to nonrandomized, nonconsecutive case series with have surgery. In critique of this study, no validated a small sample size and fairly short term follow-up. outcome measures were used, though avoiding sur- This study provides Level IV evidence that 60% of gery could be considered a valid endpoint. This study patients can obtain good or excellent pain relief at provides Level IV evidence that 65% of patients with up to six months following transforaminal epidural cervical radiculopathy can obtain pain relief to the steroid injections. level necessary to avoid surgery.

Kim et al14 retrospectively reviewed 19 patients who Anderberg et al3 described a prospective random- underwent cervical transforaminal epidural steroid ized controlled trial of 40 patients with cervical ra- injections under CT guidance. At 16 week follow-up diculopathy. They were randomized into one group patients noted an average 50% reduction in pain. In that received transforaminal epidural steroid in- critique of this study, it is retrospective and excluded jections and a control group that received transfo- any patients with neurologic deficits. Further limit- raminal injections of local anesthetic. At three week ing the relevance of this study is the small sample follow-up, 40% (8/20) of the patients in the steroid size and relatively short term follow-up. This study injection group, and 35% (7/20) of the patients in the provides Level IV evidence that, on average, patients control group noted improvement in their pain on a will experience a 50% reduction in pain 16 weeks fol- VAS. This difference was not statistically significant. lowing transforaminal epidural steroid injections. In critique of this study, no validated outcome measures were used and the sample size was very small. Kolstad et al15 described a prospective case series of This potential Level I study was downgraded to a 21 patients with cervical radiculopathy awaiting cer- Level II study because of these shortcomings. This vical disc surgery. Two cervical transforaminal epi- study provides Level II evidence that the addition dural steroid injections under fluoroscopic guidance of steroid to local anesthetic in transforaminal epi- were performed two weeks apart. Patients were fol- dural injections provides no additional therapeutic lowed for four months with approximately 25% opt- benefit at three weeks post-injection. ing to cancel surgery because of clinical improvement. In critique of this study, the sample size is Future Directions for Research small. It is difficult to make any outcome statements The work group identified the following suggestions regarding these patients other than they opted out for future studies which would generate meaningful of surgery at four months following this treatment. evidence to assist in further defining the role of epi- This study provides Level IV evidence that 25% of dural steroid injections in the management of cervi- patients awaiting cervical disc surgery can obtain cal radiculopathy from degenerative disorders. enough pain relief at four months following two cervical transforaminal epidural steroid injections to Recommendation #1: cancel surgery. Future studies of the effects of epidural steroid injections in the management of cervical radiculopa- Lin et al17 described a retrospective case series of 70 thy from degenerative disorders should include an patients considered potential surgical candidates for untreated control group when ethically possible. cervical radiculopathy. Patients underwent cervical

Recommendation #2: thy: open study on percutaneous periradicular foraminal Future outcome studies including patients with steroid infiltration performed under CT control in 30 pa- cervical radiculopathy from degenerative disorders tients. AJNR Am J Neuroradiol. Mar 2004;25(3):441-445. 11. Ellenberg MR, Honet JC, Treanor WJ. Cervical radiculopa- treated only with epidural steroid injections should thy. Arch Phys Med Rehabil. Mar 1994;75(3):342-352. include subgroup analysis for this patient popula- 12. Fish DE, Kobayashi HW, Chang TL, Pham Q. MRI prediction. tion of therapeutic response to epidural steroid injection in patients with cervical radiculopathy. Am J Phys Med Re- Recommendation #3: habil. March 2009;88(3):239-246. 13. Heckmann JG, Lang CJ, Zobelein I, Laumer R, Druschky Future studies of the effects of epidural steroid in- A, Neundorfer B. Herniated cervical intervertebral discs jections in the management of cervical radiculopa- with radiculopathy: an outcome study of conserva- thy from degenerative disorders should include data tively or surgically treated patients. J Spinal Disord. Oct and discussion about any complications associated 1999;12(5):396-401. with treatment. 14. Kim H, Lee SH, Kim MH. Multislice CT fluoroscopy-assisted cervical transforaminal injection of steroids: technical note. J Spinal Disord Tech. Aug 2007;20(6):456-461. Epidural Steroid Injection References 15. Kolstad F, Leivseth G, Nygaard OP. Transforaminal steroid 1. Alexandre A, Coro L, Azuelos A, et al. Intradiscal injection injections in the treatment of cervical radiculopathy. A of oxygen-ozone gas mixture for the treatment of cervical prospective outcome study. Acta Neurochir (Wien). Oct disc herniations. Acta Neurochir Suppl. 2005;92:79-82. 2005;147(10):1065-1070; discussion 1070. 2. Anderberg L, Annertz M, Brandt L, Saveland H. Selec- 16. Kwon JW, Lee JW, Kim SH, et al. Cervical interlaminar epi- tive diagnostic cervical nerve root block--correlation with dural steroid injection for neck pain and cervical radicu- clinical symptoms and MRI-pathology. Acta Neurochir lopathy: Effect and prognostic factors. Skeletal Radiology. (Wien). Jun 2004;146(6):559-565; discussion 565. May 2007;36(5):431-436. 3. Anderberg L, Annertz M, Persson L, Brandt L, Saveland H. 17. Lin EL, Lieu V, Halevi L, Shamie AN, Wang JC. Cervical Transforaminal steroid injections for the treatment of cer- epidural steroid injections for symptomatic disc hernia- vical radiculopathy: a prospective and randomised study. tions. J Spinal Disord Tech. May 2006;19(3):183-186. Eur Spine J. Mar 2007;16(3):321-328. 18. Pawl RP, Matz M, Wissinger JP, Vacca DF, Goldfarb RP. Epi- 4. Anderberg L, Saveland H, Annertz M. Distribution pat- dural steroids for cervical and lumbar radiculopathy. Surg terns of transforaminal injections in the cervical spine Neurol. Nov 1996;46(5):455-457. evaluated by multi-slice computed tomography. Eur Spine 19. Peloso Paul Michael J, Gross A, Haines T, et al. Medicinal J. Oct 2006;15(10):1465-1471. and injection therapies for mechanical neck disorders. 5. Benyamin R, Singh V, Parr AT, Conn A, Diwan S, Abdi S. Cochrane Database of Systematic Reviews. 2007. Systematic Review of the Effectiveness of Cervical Epidur- 20. Rosenkranz M, Grzyska U, Niesen W, et al. Anterior spinal als in the Management of Chronic Neck Pain. Pain Physi- artery syndrome following periradicular cervical nerve cian. Jan-Feb 2009;12(1):137-157. root therapy. J Neurol. Feb 2004;251(2):229-231. 6. Boswell MV, Hansen HC, Trescot AM, Hirsch JA. Epidural 21. Saal JS, Saal JA, Yurth EF. Nonoperative management of steroids in the management of chronic spinal pain and ra- herniated cervical intervertebral disc with radiculopathy. diculopathy. Pain Physician. Jul 2003;6(3):319-334. Spine. Aug 15 1996;21(16):1877-1883. 7. Bush K, Hillier S. Outcome of cervical radiculopathy treat- 22. Slipman CW, Chow DW. Therapeutic spinal corticosteroid ed with periradicular/epidural corticosteroid injections: injections for the management of radiculopathies. Phys a prospective study with independent clinical review. Eur Med Rehabil Clin N Am. Aug 2002;13(3):697-711. Spine J. 1996;5(5):319-325. 23. Strobel K, Pfirrmann CW, Schmid M, Hodler J, Boos N, Za- 8. Carragee EJ, Hurwitz EL, Cheng I, et al. Treatment of neck netti M. Cervical nerve root blocks: indications and role of pain - Injections and surgical interventions: Results of the MR imaging. Radiology. Oct 2004;233(1):87-92. bone and joint decade 2000-2010 task force on neck pain 24. Strub WM, Brown TA, Ying J, Hoffmann M, Ernst RJ, Bu- and its associated disorders. Spine. Feb 2008;33(4):S153- las RV. Translaminar cervical epidural steroid injection: S169. short-term results and factors influencing outcome.J Vasc 9. Castagnera L, Maurette P, Pointillart V, Vital JM, Erny P, Interv Radiol. Sep 2007;18(9):1151-1155. Senegas J. Long-term results of cervical epidural steroid 25. Tiso RL, Cutler T, Catania JA, Whalen K. Adverse cen- injection with and without morphine in chronic cervical tral nervous system sequelae after selective transforam- radicular pain. Pain. Aug 1994;58(2):239-243. inal block: the role of corticosteroids. Spine J. Jul-Aug 10. Cyteval C, Thomas E, Decoux E, et al. Cervical radiculopa- 2004;4(4):468-474.

What is the role of ancillary treat- approximately six weeks reported some degree of pain relief with halter traction. In critique, this case ments such as bracing, traction, series did not utilize any validated outcome mea- electrical stimulation, acupunc- sures and had a very short follow-up period. Due to these weaknesses, this potential Level IV study ture and transcutaneous electri- provides Level V evidence suggesting that 75% of cal stimulation in the treatment patients with mild radiculopathy may improve with traction over a six week time frame. of cervical radiculopathy from degenerative disorders? Saal et al8 presented a retrospective case series evaluating the use of a multifaceted medical/interven- RECOMMENDATION: Ozone injections, cervi- tional treatment program for 26 patients with cervical halter traction and combinations of medical radiculopathy. Of the 26 patients who completed cations, physical therapy, injections and traction the program, 24 were available for follow-up at three have been associated with improvements in pa- months, with 89% (22/24) of patients reporting a tient reported pain in uncontrolled case series. good treatment outcome. In critique, this study did Such modalities may be considered recognizing not utilize any validated outcome measures. This that no improvement relative to the natural study provides Level IV evidence that a multifaceted history of cervical radiculopathy has been dem- medical/interventional treatment program is asso- onstrated. ciated with good outcomes in many patients with Work Group Consensus Statement cervical radiculopathy.

Alexandre et al1 reported results of a retrospective RECOMMENDATION: Emotional and cognitive case series investigating the effects of intervertebral factors (eg, job dissatisfaction) should be consid- disc and paravertebral injections of ozone and oxy- ered when addressing surgical or medical/inter- gen in patients with CDH. The authors reported that ventional treatment for patients with cervical 80% of the 252 patients experienced some degree radiculopathy from degenerative disorders. symptom relief at some point following the injections. In critique, this case series did not utilize any GRADE OF RECOMMENDATION: validated outcome measures, report specific data or I (Insufficient Evidence) delineate a specific follow-up period. No compari- 7 son to the natural history was made. Due to these Persson et al conducted a prospective randomized weaknesses, this potential Level IV study provides controlled trial comparing coping strategies, pain Level V evidence suggesting that approximately 80% and emotional relationships of patients with cervi- of patients will report symptomatic relief from cer- cal radiculopathy of at least three months duration vical radiculopathy at some point following ozone randomly assigned to one of three treatment groups. and oxygen injection into the intervertebral disc and Of the 81 patients included in the study, 27 were as- paravertebral musculature. signed to cervical bracing, 27 to physical therapy and 27 to ACDF (Cloward technique). Three patients as- Olivero et al6 discussed a retrospective case series signed to the surgical group refused the procedure evaluating the use of halter traction and collar in pa- and were handled in intent to treat analysis. In the tients with mild cervical radiculopathy. The authors surgical group, eight patients had a second opera- reported that of the 81 patients included in the study, tion: six on adjacent level, one infection and one 75% of patients with mild cervical radiculopathy of plexus exploration. Eleven patients in the surgery group also received physical therapy. One patient

in the physical therapy group and five in the collar need to improve coping strategies, self image and group had surgery with Cloward technique. mood.

Chronic symptoms influenced both function and In critique, neither patients nor reviewers were mental well being such as emotional state, level of masked to treatment group, the sample size was anxiety, depression, sleep and coping behavior. Pain small and duration of follow-up was short. Due to was the most important primary stressor. Surgery these limitations, this potential Level I study pro- reduced the pain faster, but no difference was seen vides Level II evidence that there is a high incidence after 12 months. Reoperation rate was 29%, mostly of behavioral and emotional dysfunction in cervical for adjacent segment disease. The low positive mood radiculopathy patients. Medical/interventional and state (MACL score) did not improve over time. Pa- surgical treatment must include a cognitive, behav- tients who still had pain after treatment were more ioral component for either method to be successful. socially withdrawn and ceased to express their emotions. The Hospital Anxiety and Depression (HAD) Future Directions for Research anxiety score was especially high in patients before The work group identified the following suggestions and after treatment. In patients with high pain inten- for future studies which would generate meaning- sity, low function, high depression and anxiety were ful evidence to assist in further defining the role of seen. The group treated with surgery showed more ancillary treatments in the management of cervical anxiety and depression if pain continued, implying radiculopathy from degenerative disorders. higher expectations and more disappointment if it failed. The strongest correlation between depression Recommendation #1: and pain was seen in the collar group, possibly be- Future studies of the effects of ancillary treatments cause they received less attention overall. In gener- in the management of cervical radiculopathy from al, coping strategies changed. Active coping (cogni- degenerative disorders should include an untreated tive reappraisal and problem solving) was common control group when ethically possible. before treatment, but disappeared after treatment, Recommendation #2: especially in the surgical group. Coping with pain Future outcome studies including patients with was changed in general into a more passive/escape cervical radiculopathy from degenerative disorders focused strategy. It appeared that with intervention, treated only with ancillary treatments should in- especially surgery, healthy active coping strategies clude subgroup analysis for this patient population. tended to be replaced by passive coping strategies as patients allowed themselves to become more de- Recommendation #3: pendent on the intervention. This also implied that Future studies evaluating the effects of emotional, the ability for active coping was present before in- cognitive and work-related issues would add to our tervention, and thus cognitive behavioral treatment understanding of how these factors affect outcomes started concurrently with other interventions may in patients with cervical radiculopathy from degen- be particularly successful for maintaining better erative disorders. coping patterns. Function was significantly related to pain intensity. About 40% had anxiety only par- Ancillary Treatment References tially connected to pain. Prior to treatment, 30% of 1. Alexandre A, Coro L, Azuelos A, et al. Intradiscal injection patients were depressed. After 12 months, 20% suf- of oxygen-ozone gas mixture for the treatment of cervical disc herniations. Acta Neurochir Suppl. 2005;92:79-82. fered from depression. The authors concluded that 2. Constantoyannis C, Konstantinou D, Kourtopoulos H, cognitive and behavioral therapy is important to Papadakis N. Intermittent cervical traction for cervical include in multidisciplinary rehabilitation. Patients radiculopathy caused by large-volume herniated disks. J Manipulative Physiol Ther. Mar-Apr 2002;25(3):188-192.

3. Ellenberg MR, Honet JC, Treanor WJ. Cervical radiculopa- 7. Persson LC, Lilja A. Pain, coping, emotional state and thy. Arch Phys Med Rehabil. Mar 1994;75(3):342-352. physical function in patients with chronic radicular neck 4. LaBan MM, Macy JA, Meerschaert JR. Intermittent cervi- pain. A comparison between patients treated with surgery, cal traction: a progenitor of lumbar radicular pain. Arch physiotherapy or neck collar--a blinded, prospective ran- Phys Med Rehabil. Mar 1992;73(3):295-296. domized study. Disabil Rehabil. May 20 2001;23(8):325- 5. Matsumoto M, Chiba K, Ishikawa M, Maruiwa H, Fujimura 335. Y, Toyama Y. Relationships between outcomes of conser- 8. Saal JS, Saal JA, Yurth EF. Nonoperative management of vative treatment and magnetic resonance imaging find- herniated cervical intervertebral disc with radiculopathy. ings in patients with mild cervical myelopathy caused by Spine. Aug 15 1996;21(16):1877-1883. soft disc herniations. Spine. Jul 15 2001;26(14):1592-1598. 9. Verbiest H. Chapter 23. The management of cervical spon- 6. Olivero WC, Dulebohn SC. Results of halter cervical trac- dylosis. Clin Neurosurg. 1973;20:262-294. tion for the treatment of cervical radiculopathy: retro- 10.. Waldrop MA. Diagnosis and treatment of cervical radicu- spective review of 81 patients. Neurosurg Focus. Feb 15 lopathy using a clinical prediction rule and a multimodal 2002;12(2):ECP1. intervention approach: a case series. J Orthop Sports Phys Ther. Mar 2006;36(3):152-159.

D. Surgical Treatment

Does surgical treatment (with or groups and improvement in pain scores in the surgical group was significantly better than in the col- without preoperative medical/in- lar group. After another year, the pain was about the terventional treatment) result in same across groups. The surgical group improved strength a little faster, but at final follow-up strength better outcomes than medical/in- improvement was equal across groups. At final fol- terventional treatment for cervi- low-up, there was no difference between groups on the sensory exam. The authors concluded that there cal radiculopathy from degenera- was no difference in outcomes after one year be- tive disorders? tween patients treated with a collar, physical therapy or surgery.

RECOMMENDATION: Surgical intervention is In critique, neither patients nor reviewers were suggested for the rapid relief of symptoms of masked to treatment group, the sample size was cervical radiculopathy from degenerative disor- small and duration of follow-up was short. Due to ders when compared to medical/interventional these limitations, this potential Level I study pro- treatment. vides Level II evidence that at one year, outcomes are similar for medical/interventional treatment GRADE OF RECOMMENDATION: B and surgical treatment of patients with cervical radiculopathy from degenerative disorders. Due to Persson et al48 described a prospective random- the small sample size, one may not expect to see a ized controlled trial comparing outcomes in pain, difference between the groups on a statistical basis. strength and sensation in three treatment groups of Surgical treatment resulted in improved outcomes patients with cervical radiculopathy of a minimum earlier in the postoperative treatment period when of three months duration. Of the 81 patients includ- compared with the medical/interventional treated in the study, 27 were assigned to cervical brac- ment group. ing, 27 to physical therapy and 27 to ACDF (Cloward technique). Three surgical patients refused the pro- Sampath et al53 reported results of a prospective, cedure and were handled in intent to treat analysis. multicenter comparative study evaluating clinical In the surgical group, eight patients had a second outcomes in patients with cervical radiculopathy. operation: six on adjacent level, one infection and Medical/interventional treatment was nonstan- one plexus exploration. Eleven patients in the sur- dardized in this multicenter trial and included med- gery group also received physical therapy. One pa- ications, steroids, bed rest, exercise, traction, brac- tient in the physical therapy group and five in the ing, injections, chiropractic care, acupuncture and collar group had surgery with Cloward technique. homeopathic medicine. Surgery included foraminotomy, ACD and ACDF. Of the 246 patients with Strength measurements were all performed by one radiculopathy, 160 were nonrandomized to medical physical therapist with standard protocol. Physical treatment and 86 received surgical treatment. Of the therapy was done for 15 visits and was not standard- 246 patients, only 155 reported data at final follow- ized. Several different collars were used and worn up. Of the 155 patients, 104 were medically/inter- for three months. At four month follow-up, pain ventionally treated and 51 had surgery. was improved in the surgical and physical therapy

In general, pain scores were worse in the surgical cal radiculopathy of at least three months duration group preoperatively than in the medical/inter- randomly assigned to one of three treatment groups. ventional treatment group. Both groups improved Of the 81 patients included in the study, 27 were as- significantly, with greater improvement seen in the signed to cervical bracing, 27 to physical therapy and surgical group. Patient satisfaction, neurological im- 27 to ACDF (Cloward technique). Three patients as- provement and functional improvement were seen signed to the surgical group refused the procedure in both groups, with greater improvement reported and were handled in intent to treat analysis. In the in the surgical group. There was significant improve- surgical group, eight patients had a second opera- ment in activities of daily living (ADL) in the surgi- tion: six on adjacent level, one infection and one cal group. Although there was improvement, there plexus exploration. Eleven patients in the surgery was still significant pain in about 26% of surgical pa- group also received physical therapy. One patient tients. The number returning to work did not differ in the physical therapy group and five in the collar before and after intervention in either group despite group had surgery with Cloward technique. improved functional ability, implying that the most important factor for return to work was work status Chronic symptoms influenced both function and prior to treatment. The authors concluded that sur- mental well being such as emotional state, level of gery appears to have more success than medical/in- anxiety, depression, sleep and coping behavior. Pain terventional treatment, although both help. Despite was the most important primary stressor. Surgery this, a substantial percentage of patients continue reduced the pain faster, but no difference was seen to have severe pain, neurologic symptoms and no after 12 months. Reoperation rate was 29%, mostly work activity. for adjacent segment disease. The low positive mood state (MACL score) did not improve over time. Pa- In critique, this was a nonrandomized study which tients who still had pain after treatment were more did not utilize validated outcome measures. There socially withdrawn and ceased to express their emo- was a high attrition rate to follow-up and the length tions. The Hospital Anxiety and Depression (HAD) of follow-up was short. Both medical/interventional anxiety score was especially high in patients before and surgical treatment protocols were nonstandard- and after treatment. In patients with high pain inten- ized. Due to these limitations, this potential Level II sity, low function, high depression and anxiety were study provides Level III evidence that surgical treat- seen. The group treated with surgery showed more ment results in improved outcomes when compared anxiety and depression if pain continued, implying with medical/interventional treatment on short higher expectations and more disappointment if it term follow-up. failed. The strongest correlation between depression and pain was seen in the collar group, possibly be- RECOMMENDATION: Emotional and cognitive cause they received less attention overall. In gener- factors (eg, job dissatisfaction) should be consid- al, coping strategies changed. Active coping (cogni- ered when addressing surgical or medical/inter- tive reappraisal and problem solving) was common ventional treatment for patients with cervical before treatment, but disappeared after treatment, radiculopathy from degenerative disorders. especially in the surgical group. Coping with pain was changed in general into a more passive/escape GRADE OF RECOMMENDATION: focused strategy. It appeared that with intervention, I (Insufficient Evidence) especially surgery, healthy active coping strategies tended to be replaced by passive coping strategies Persson et al47 conducted a prospective randomized as patients allowed themselves to become more de- controlled trial comparing coping strategies, pain pendent on the intervention. This also implied that and emotional relationships of patients with cervi- the ability for active coping was present before in-

This clinical guideline should not be construed as including all proper methods of care or excluding other acceptable methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding any specific procedure or treatment is to be made by the physician and patient in light of all circumstances presented by the patient and the needs and resources particular to the locality or institution. NASS Clinical Guidelines – Diagnosis and Treatment of Cervical Radiculopathy from Degenerative Disorders 52 tervention, and thus cognitive behavioral treatment in patients with cervical radiculopathy from degen- started concurrently with other interventions may erative disorders. be particularly successful for maintaining better coping patterns. Function was significantly related References to pain intensity. About 40% had anxiety only par- 1. Anderson PA, Sasso RC, Riew KD. Comparison of adverse tially connected to pain. Prior to treatment, 30% of events between the Bryan artificial cervical disc and anterior cervical arthrodesis. Spine. 2008:1305-1312. patients were depressed. After 12 months, 20% suf- 2. Arnasson O, Carlsson CA, Pellettieri L. Surgical and con- fered from depression. The authors concluded that servative treatment of cervical spondylotic radiculopathy cognitive and behavioral therapy is important to and myelopathy. Acta Neurochir (Wien). 1987;84(1-2):48- include in multidisciplinary rehabilitation. Patients 53. need to improve coping strategies, self image and 3. Bartels RH, Donk R, van der Wilt GJ, Grotenhuis JA, Ven- derink D. Design of the PROCON trial: a prospective, ran- mood. domized multi-center study comparing cervical anterior discectomy without fusion, with fusion or with arthro- In critique, neither patients nor reviewers were plasty. BMC Musculoskelet Disord. 2006;7:85. masked to treatment group, the sample size was 4. Bartels RH, Verbeek AL, Grotenhuis JA. Design of Lami- small and duration of follow-up was short. Due to fuse: a randomised, multi-centre controlled trial comparing laminectomy without or with dorsal fusion for these limitations, this potential Level I study pro- cervical myeloradiculopathy. BMC Musculoskelet Disord. vides Level II evidence that there is a high incidence 2007;8:111. of behavioral and emotional dysfunction in cervical 5. Bertalanffy H, Eggert HR. Clinical long-term results of an- radiculopathy patients. Medical/interventional and terior discectomy without fusion for treatment of cervical surgical treatment must include a cognitive, behav- radiculopathy and myelopathy. A follow-up of 164 cases. Acta Neurochir (Wien). 1988;90(3-4):127-135. ioral component for either method to be successful. 6. Boswell MV, Hansen HC, Trescot AM, Hirsch JA. Epidural steroids in the management of chronic spinal pain and ra- Future Directions for Research diculopathy. Pain Physician. Jul 2003;6(3):319-334. The work group identified the following suggestions 7. Brodke DS, Zdeblick TA. Modified Smith-Robinson pro- for future studies which would generate meaning- cedure for anterior cervical discectomy and fusion. Spine. Oct 1992;17(10 Suppl):S427-430. ful evidence to assist in further defining the role of 8. Bruneau M, Nisolle JF, Gilliard C, Gustin T. Anterior cer- medical/interventional and surgical treatment in vical interbody fusion with hydroxyapatite graft and plate the management of cervical radiculopathy from de- system. Neurosurg Focus. 2001;10(4):E8. generative disorders. 9. Bucciero A, Vizioli L, Cerillo A. Soft cervical disc herniation. An analysis of 187 cases. J Neurosurg Sci. Sep 1998;42(3):125-130. Recommendation #1: 10. Caglar YS, Bozkurt M, Kahilogullari G, et al. Keyhole ap- A prospective, multicenter randomized controlled proach for posterior cervical discectomy: experience on trial (RCT) with minimum two year follow-up com- 84 patients. Minim Invasive Neurosurg. Feb 2007;50(1):7- paring surgical to medical/interventional treatment 11. for the treatment of cervical radiculopathy from de- 11. Carragee EJ, Hurwitz EL, Cheng I, et al. Treatment of neck pain - Injections and surgical interventions: Results of the generative disorders would yield invaluable infor- bone and joint decade 2000-2010 task force on neck pain mation regarding the relative outcomes of these two and its associated disorders. Spine. Feb 2008;33(4):S153- treatment options. S169. 12. Cornelius JF, Bruneau M, George B. Microsurgical cervical Recommendation #2: nerve root decompression via an anterolateral approach: Clinical outcome of patients treated for spondylotic radic- Future studies evaluating the effects of emotional, ulopathy. Neurosurgery. Nov 2007;61(5):972-980. cognitive and work-related issues would add to our 13. Dai LY, Jiang LS. Anterior cervical fusion with interbody understanding of how these factors affect outcomes cage containing beta-tricalcium phosphate augmented with plate fixation: a prospective randomized study with

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549; discussion 550. ment of cervical radiculopathy. Acta Neurol Scand. Sep 40. Matge G, Leclercq TA. Rationale for interbody fusion with 1994;90(3):197-200. threaded titanium cages at cervical and lumbar levels. Re- 52. Ruetten S, Komp M, Merk H, Godolias G. A new full-endo- sults on 357 cases. Acta Neurochir (Wien). 2000;142(4):425- scopic technique for cervical posterior foraminotomy in 434. the treatment of lateral disc herniations using 6.9-mm en- 41. Mobbs RJ, Rao P, Chandran NK. Anterior cervical discec- doscopes: prospective 2-year results of 87 patients. Minim tomy and fusion: analysis of surgical outcome with and Invasive Neurosurg. Aug 2007;50(4):219-226. without plating. J Clin Neurosci. Jul 2007;14(7):639-642. 53. Sampath P, Bendebba M, Davis JD, Ducker T. Outcome in 42. Mummaneni PV, Burkus JK, Haid RW, Traynelis VC, Zde- patients with cervical radiculopathy. Prospective, multi- blick TA. 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64. Zeidman SM, Ducker TB. Posterior cervical laminoforami- compared to ICBG had similar outcomes but more notomy for radiculopathy: review of 172 cases. Neurosur- kyphotic deformity at medium length follow-up. gery. Sep 1993;33(3):356-362. 65. Zoega B, Karrholm J, Lind B. Outcome scores in degenerative cervical disc surgery. Eur Spine J. Apr 2000;9(2):137- In critique, neither reviewers nor patients were 143. masked to treatment group and the randomization process was not described. No validated outcome measures were utilized, the sample size was small Does ACDF result in better out- and length of follow-up was short. Use of PMMA as comes (clinical or radiographic) a spacer is not standard practice. Due to these limitations, this potential Level II RCT provides Level III than ACD alone? evidence that suggests that there are variable outcomes when comparing ACD to ACDF for the treat- RECOMMENDATION: Both ACD and ACDF ment of cervical radiculopathy due to single level de- are suggested as comparable treatment strate- generative disease. In one cohort comparing ACD to gies, producing similar clinical outcomes, in the fusion with ICBG, outcomes were equivalent, while treatment of single level cervical radiculopathy another cohort showed superiority of interbody fu- from degenerative disorders. sion with a titanium cage and allograft versus ACD. Validity of conclusions is weakened by small sample GRADE OF RECOMMENDATION: B size and short follow-up. Barlocher et al3 conducted a prospective random- Hauerberg et al9 reported results of a prospective ized controlled trial comparing outcomes of ACD to randomized controlled trial comparing radiograph- three different types of ACDF: iliac crest bone graft ic and clinical outcomes of ACD with ACDF using (ICBG), polymethylmethacrylate (PMMA) and tita- a titanium cage. Of the 86 patients included in the nium cages. All patients had single level degenerative study, 46 were randomized to the ACD group and 40 disease. Of the 125 patients included in the study, to ACDF. One patient withdrew in each group. Two 33 were assigned to the ACD group, 30 to ICBG, 26 year follow-up data were available for 36 cage and to PMMA and 36 to titanium cages. At one year fol- 43 ACD patients. Early outcomes, though not statis- low-up, 123 patients were available. The functional tically significant, favored ACD. At two years 63% of outcomes were grouped by good and excellent to ACD patients and 78% of cage patients reported good poor and fair, with good/excellent results reported outcomes (not statistically significant). Reoperation for 75% of the ACDF group, 80% for ICBG, 87% for rates at the same level were reported as follows: at PMMA and 94% for cage. Average reported kyphosis three months, three reoperations in ACD group, two for ACD patients was 24 degrees, with one patient in cage group; at one year, an additional reoperation requiring revision surgery (31 degrees); 12 degrees in each group; at two years, an additional three in for PMMA and about three degrees for the ICBG and the ACD group. There were some additional pro- cage groups. Twelve month fusion results based on cedures at adjacent levels that were equivalent for flexion and extension radiographs were reported as both groups over two years. In total, for the ACD 93% for the ACD patients, 93% for ICBG and 97% for group, 17/46 were investigated, seven had the same cage. Fusion rate was faster in the cage group as well level reoperation and two had adjacent level opera- with 86% achieving fusion at six months compared tions. In the cage group, 15/40 were investigated with 61% in the ACD group and 65% in the ICBG with three having same level reoperation and three group. The authors concluded that ACDF with cage having adjacent level operations. There were no sta- did significantly better with faster and better re- tistically significant differences reported in kyphosis covery and less kyphotic deformity than ACD. ACD

or fusion rate. The authors concluded that there was outcome measures were utilized and follow-up was no difference in outcome at two years between ACD short. Due to these limitations, this potential Level and ACDF with cage and local autograft bone. II study provides Level III evidence that for cervical radiculopathy due to single level degenerative dis- In critique, the reviewers were not masked to treat- ease, ACD alone provides satisfactory clinical out- ment group, no validated outcome measures were comes when compared to ACDF with allograft ICBG used and the sample size was small. Due to these and semirigid plate. Radiographically, disc height limitations, this potential Level I RCT provides Level is maintained significantly better with plate and fu- II evidence that for cervical radiculopathy due to sion although the clinical significance is unknown. single level degenerative disease, clinical outcomes The validity of the conclusions is uncertain due to are similar at two years for patients undergoing ACD small sample size. and ACDF with threaded titanium cage and local autograft. Fusion rates and symptomatic adjacent Savolainen et al19 reported results of a prospective segment disease were also similar between the two randomized controlled trial comparing clinical re- groups. sults of ACD to ACDF with or without plate. Of the 91 patients included in the study, follow-up data were Oktenoglu et al16 described a prospective random- reported for 88 patients. Good/excellent results were ized controlled trial comparing radiographic and reported in 76% of ACD patients, 82% ACDF and clinical outcomes of ACD and ACDF with plate. Of 73% ACDFP. Of the 88 patients, 71 had long term ra- the 20 patients included in the study, 11 were as- diographic follow-up, with slight kyphosis in 62% of signed to the ACD group and nine to the ACDF ACD, 41% ACDF, 44% ACDFP and fusion achieved group. Inclusion criteria required only two weeks in 100% of ACDF and 90% of ACD patients. Compli- of failed medical/interventional treatment. VAS up- cation rates were similar for all groups, with the ex- per extremity pain scores (dominant complaint) im- ception of short term ICBG pain which was severe proved significantly in both groups, from mean 8 to in 80% of both ACDF groups. The authors concluded 3. Although less severe initially than arm pain, VAS that because outcomes were similar for the three neck pain scores had less improvement overall, but groups, ACD is recommended as the procedure of statistically significant improvement was noted in choice for ease of surgery and reduced complica- the ACDF group. CT follow-up at one year showed tions. disc space collapse in both groups, but significantly more in the ACD group. There was some subsid- In critique, neither patients nor reviewers were ence of the graft over the first year. Final foraminal masked to treatment group. The randomization pro- dimensions were slightly larger in ACDF group, but cess was not specified. No validated outcome mea- not significant. Reported fusion rates were 100% in sures were used and the sample size was small. Pa- the ACDF group and 45% (5/11) in the ACD group. tients were seen up to six months following surgery, The authors concluded that ACD alone provides and then final follow-up at four years was conduct- satisfactory clinical outcomes when compared to ed via telephone interview. Due to these limitations, ACDF with semirigid plate. this potential Level II study provides Level III evidence that for patients with cervical radiculopathy In critique, patients were not masked to treatment due to single level degenerative disease, ACD yields group and duration of symptoms for study inclusion results equivalent to ACDF with or without a plate. was short. Randomization was accomplished by The validity of the conclusion is uncertain due to coin flip and the sample size was small. No validated small sample size.

Wirth et al24 conducted a prospective randomized tients included in the study, 15 were randomly as- controlled trial comparing clinical outcomes of signed to each treatment group. Three patients in the ACD, ACDF and posterior cervical foraminotomy ACD group were lost to follow-up. No graft site pain for single level HNP with radiculopathy. Of the 72 was reported at two years. In general, clinical results consecutively assigned patients included in the improved to one year then plateaued. Arm pain was study, 22 were assigned to foraminotomy, 25 to completely absent in 92% of ACD patients, 93% of ACD and 25 to ACDF. For immediate postoperative ACDF patients and 100% of ACDFI patients. Neck results, surgical time, hospital stay and cost were pain was absent in 83%, 80% and 73%, respective- slightly better for the ACD group. Postoperative ly. All had significant and similar improvements in pain was worse in the foraminotomy group. At two McGill Pain Questionnaire and SF-36. At two years, months, according to the non validated grading fusion rate on radiograph was 67%, 93%, and 100% scheme implemented, all three groups were about respectively. Of patients treated with ACD, 75% had the same. Reoperations were greater at the operative kyphosis at two years. The authors concluded that site for foraminotomy and adjacent sites for ACDF patient selection is the key to surgical success. Any patients. Long-term follow-up was accomplished via of these surgeries are suitable for cervical radicul- phone interview at 53 months for the foraminotomy opathy due to nerve root compression. Because the group (14/22 patients), 56 months for the ACD group long term effects of kyphosis are unknown, the po- (13/25 patients) and 69 months for the ACDF group tential consequences of ACD remain uncertain. (16/25 patients), with a loss of about 40% of patients to follow-up. Within the limits of their study design In critique, neither the patients nor reviewers were and patient capture, pain improvement remained masked to treatment group, and the sample size was high for all groups. Return to work was 79% for the small. Due to these limitations, this potential Level foraminotomy group, 92% for ACD and 81% for I study provides Level II evidence that clinical out- ACDF (not statistically significant). Of the patients comes for treatment of cervical radiculopathy due available at final follow-up, 100% were satisfied to single level degenerative disease are similar when and would have the surgery again. The authors comparing ACD to ACDF, with or without plating. concluded that for single level HNP, all procedures Radiographic outcomes were worse with ACD, re- are efficacious. sulting in a significant loss of lordosis, although the clinical consequences of this are unknown. The va- In critique, neither patients nor reviewers were lidity of the conclusions may be compromised by a masked to the treatment group and the random- very small sample size. ization method was poor. No validated outcome measures were utilized to assess this small patient RECOMMENDATION: The addition of an sample. Approximately 40% of patients were lost to interbody graft for fusion is suggested to follow-up. Because of these limitations, this poten- improve sagittal alignment following ACD. tial Level II study provides Level III evidence that for single level HNP causing cervical radiculopathy, GRADE OF RECOMMENDATION: B outcomes for ACD are equivalent to ACDF. Barlocher et al3 conducted a prospective random- Xie et al25 reported results of a prospective randomized controlled trial comparing outcomes of ACD ized controlled trial comparing clinical and radio- to three different types of ACDF: ICBG, PMMA and graphic outcomes of ACD, ACDF, and anterior cer- titanium cages. All patients had one level disease. Of vical discectomy with instrumented fusion (ACDFI) the 125 patients included in the study, 33 were as- for single level cervical radiculopathy. Of the 45 pa- signed to the ACD group, 30 to ICBG, 26 to PMMA

and 36 to titanium cages. At one year follow-up, 123 pain was reported at two years. In general, clinical patients were available. The functional outcomes results improved to one year then plateaued. Arm were grouped by good and excellent to poor and fair, pain was completely absent in 92% of ACD patients, with good/excellent results reported for 75% of the 93% of ACDF patients and 100% of ACDFI patients. ACDF group, 80% for ICBG, 87% for PMMA and 94% Neck pain was absent in 83%, 80% and 73%, respec- for cage. Average reported kyphosis for ACD patients tively. All had significant and similar improvements was 24 degrees, with one patient requiring revision in McGill Pain Questionnaire and SF-36. At two surgery (31 degrees); 12 degrees for PMMA and years, fusion rate on radiograph was 67%, 93%, and about three degrees for the ICBG and cage groups. 100% respectively. Of patients treated with ACD, Twelve month fusion results were reported as 93% 75% had kyphosis at two years. Approximately 25% for the ACD patients, 93% for ICBG and 97% for cage. had kyphosis between 5 and 15 degrees, while the Fusion rate was faster in the cage group as well with other 50% were between 0 and 5 degrees. It should 86% achieving fusion at six months compared with be noted that 15% of the patients had some measure 61% in the ACD group and 65% in the ICBG group. of preoperative kyphosis. In both the ACDF and The authors concluded that ACDF with cage did sig- ACDFI groups, less than 5% of patients had a kypho- nificantly better with faster and better recovery and sis of 5 to 15 degrees at final follow up. There was 0 less kyphotic deformity than ACD. ACD compared to 5 degrees of kyphosis in approximately 30% and to ICBG had similar outcomes at medium length 20% of the ACDF and ACDFI groups respectively. follow-up. Pre operative kyphosis was noted in 20% and 30% respectively. Looking at the data more closely, there In critique, neither reviewers nor patients were was a clear loss of kyphosis in the ACD group. In the masked to treatment group and the randomization ACDF group, alignment tended to remain close to process was not described. No validated outcome the pre operative condition in general, with slight measures were utilized, the sample size was small subsidence and minimal loss of kyphosis in a small and length of follow-up was short. Use of PMMA as percent of patients such that at final follow up pre a spacer is not standard practice. Due to these limi- and post operative sagittal alignment were gener- tations, this potential Level II RCT provides Level III ally similar. If these patients exhibited pre operative evidence that suggests that there are variable out- segmental kyphosis, they tended to stay that way, as comes when comparing ACD to ACDF for the treat- did those with pre operative lordosis. In the ACDFI ment of cervical radiculopathy due to single level group, there was a trend towards improved sagittal degenerative disease. While not the primary out- alignment when comparing pre and post operative come measure, radiographic sagittal alignment was lordosis. The authors concluded that patient selec- clearly better with ACDF compared to ACD. Validity tion is the key to surgical success. Any of these sur- of conclusions are weakened by small sample size geries are suitable for cervical radiculopathy due to and short follow-up. nerve root compression. There was a clear advantage for maintaining sagittal alignment with either Xie et al25 reported results of a prospective random- ACDF or ACDFI. Because the long term effects of ized controlled trial comparing clinical and radio- kyphosis are unknown, the potential consequences graphic outcomes of ACD, ACDF, and anterior cer- of ACD remain uncertain. vical discectomy with instrumented fusion (ACDFI) for single level cervical radiculopathy. Of the 45 pa- In critique, neither the patients nor reviewers were tients included in the study, 15 were randomly as- masked to treatment group, and the sample size was signed to each treatment group. Three patients in small. Due to these limitations, this potential Level the ACD group were lost to follow-up. No graft site I study provides Level II evidence that clinical out-

This clinical guideline should not be construed as including all proper methods of care or excluding other acceptable methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding any specific procedure or treatment is to be made by the physician and patient in light of all circumstances presented by the patient and the needs and resources particular to the locality or institution. NASS Clinical Guidelines – Diagnosis and Treatment of Cervical Radiculopathy from Degenerative Disorders 59 comes for treatment of cervical radiculopathy due 6. Donaldson JW, Nelson PB. Anterior cervical discectomy to single level degenerative disease are similar when without interbody fusion. Surg Neurol. Apr 2002;57(4):219- comparing ACD to ACDF, with or without plating. 224; discussion 224-215. 7. Dowd GC, Wirth FP. Anterior cervical discectomy: is fu- Radiographic outcomes were worse with ACD, re- sion necessary? J Neurosurg. Jan 1999;90(1 Suppl):8-12. sulting in a significant loss of lordosis, although the 8. Gaetani P, Tancioni F, Spanu G, Rodriguez y Baena R. Ante- clinical consequences of this are unknown. The va- rior cervical discectomy: an analysis on clinical long-term lidity of the conclusions may be compromised by a results in 153 cases. J Neurosurg Sci. Dec 1995;39(4):211- very small sample size. 218. 9. Hauerberg J, Kosteljanetz M, Boge-Rasmussen T, et al. An- terior cervical discectomy with or without fusion with ray Future Directions for Research titanium cage: a prospective randomized clinical study. The work group identified the following suggestions Spine. Mar 1 2008;33(5):458-464. for future studies which would generate meaningful 10. Husag L, Costabile G, Vanloffeld W, Keller RJD, Landolt evidence to assist in further defining the role of fu- H. Anterior cervical discectomy without fusion: A comparison with Cloward’s procedure. J Clin Neurosci. Jul sion with ACD in the surgical treatment of cervical 1997;4(3):331-340. radiculopathy from degenerative disorders. 11. Jacobs WC, Anderson PG, Limbeek J, Willems PC, Pavlov P. Single or double-level anterior interbody fusion tech- Prospective, blinded, RCT comparing clinical out- niques for cervical degenerative disc disease. Cochrane comes and radiographic alignment of patients treat- Database Syst Rev. 2004(4):CD004958. 12. Klaiber RD, Vonammon K, Sarioglu AC. Anterior Micro- ed for cervical radiculopathy due to single level de- surgical Approach for Degenerative Cervical Disk Disease. generative disease with ACD compared with ACDF Acta Neurochir (Wien). 1992;114(1-2):36-42. with a uniform surgical technique would generate 13. Maurice-Williams RS, Elsmore A. Extended anterior cervi- important information about the relative value of cal decompression without fusion: a long-term follow-up preserving normal alignment. study. Br J Neurosurg. Oct 1999;13(5):474-479. 14. Murphy MA, Trimble MB, Piedmonte MR, Kalfas IH. Changes in the cervical foraminal area after anterior References discectomy with and without a graft. Neurosurgery. Jan 1. Abd-Alrahman N, Dokmak AS, Abou-Madawi A. Anterior 1994;34(1):93-96. cervical discectomy (ACD) versus anterior cervical fusion 15. Naderi S, Ozgen S, Ozek MM, Pamir MN. Cervical disc her- (ACF), clinical and radiological outcome study. Acta Neu- niations: When to fuse? Neuro-Orthopedics. 2000;28(1):27- rochir (Wien). 1999;141(10):1089-1092. 38. 2. Alvarez JA, Hardy RW. Anterior cervical discectomy for 16. Oktenoglu T, Cosar M, Ozer AF, et al. Anterior cervical one- and two-level cervical disc disease: the controversy microdiscectomy with or without fusion. J Spinal Disord surrounding the question of whether to fuse, plate, or Tech. Jul 2007;20(5):361-368. both. Crit Rev Neurosurg. Jul 1999;9(4):234-251. 17. Pointillart V, Cernier A, Vital JM, Senegas J. Anterior dis- 3. Barlocher CB, Barth A, Krauss JK, Binggeli R, Seiler RW. cectomy without interbody fusion for cervical disc hernia- Comparative evaluation of microdiscectomy only, au- tion. Eur Spine J. 1995;4(1):45-51. tograft fusion, polymethylmethacrylate interposition, and 18. Rao PJ, Christie JG, Ghahreman A, Cartwright CA, Ferch threaded titanium cage fusion for treatment of single-level RD. Clinical and functional outcomes of anterior cervi- cervical disc disease: a prospective randomized study in cal discectomy without fusion. J Clin Neurosci. December 125 patients. Neurosurg Focus. Jan 15 2002;12(1):E4. 2008;15(12):1354-1359. 4. Bartels RH, Donk R, van der Wilt GJ, Grotenhuis JA, Ven- 19. Savolainen S, Rinne J, Hernesniemi J. A prospective ran- derink D. Design of the PROCON trial: a prospective, randomized study of anterior single-level cervical disc opera- domized multi-center study comparing cervical anterior tions with long-term follow-up: surgical fusion is unnec- discectomy without fusion, with fusion or with arthro- essary. Neurosurgery. Jul 1998;43(1):51-55. plasty. BMC Musculoskelet Disord. 2006;7:85. 20. Tegos S, Rizos K, Papathanasiu A, Kyriakopulos K. Re- 5. Bertalanffy H, Eggert HR. Clinical long-term results of an- sults of anterior discectomy without fusion for treatment terior discectomy without fusion for treatment of cervical of cervical radiculopathy and myelopathy. Eur Spine J. radiculopathy and myelopathy. A follow-up of 164 cases. 1994;3(2):62-65. Acta Neurochir (Wien). 1988;90(3-4):127-135. 21. Thorell W, Cooper J, Hellbusch L, Leibrock L. The long-

term clinical outcome of patients undergoing anterior tween groups for either of these outcome measures. cervical discectomy with and without intervertebral bone Radiographically, there was no difference in the fre- graft placement. Neurosurgery. Aug 1998;43(2):268-273; quency of pseudoarthrosis/nonunion. The authors discussion 273-264. 22. Watters WC, 3rd, Levinthal R. Anterior cervical discectomy defined inferior “graft quality” as ventral graft dislo- with and without fusion. Results, complications, and long- cation greater than 2mm and/or loss of disc height term follow-up. Spine. Oct 15 1994;19(20):2343-2347. by more than 2mm. Based upon these criteria, the 23. White BD, Fitzgerald JJ. To graft or not to graft: rationaliz- plate group had significantly better results (p=.04). ing choice in anterior cervical discectomy. Br J Neurosurg. The authors concluded that addition of an anterior Apr 2005;19(2):148-154. 24. Wirth FP, Dowd GC, Sanders HF, Wirth C. Cervical dis- cervical plate did not lead to an improved clinical cectomy. A prospective analysis of three operative tech- outcome for patients treated for cervical radiculopa- niques. Surg neurol. 2000:340-346; discussion 346-348. thy with a one or two level anterior procedure. 25. Xie JC, Hurlbert RJ. Discectomy versus discectomy with fusion versus discectomy with fusion and instrumenta- In critique, patients were not masked to treatment tion: a prospective randomized study. Neurosurgery. Jul 2007;61(1):107-116; discussion 116-107. group and no validated outcome measures were 26. Yamamoto I, Ikeda A, Shibuya N, Tsugane R, Sato O. utilized to assess this small sample of patients. The Clinical long-term results of anterior discectomy with- authors did not indicate that the patients were con- out interbody fusion for cervical disc disease. Spine. Mar secutively assigned and utilized a questionable ran- 1991;16(3):272-279. domization method. Due to these limitations, this

potential Level I study provides Level II evidence that Does ACDF with instrumentation the addition of a plate does not improve outcomes following ACDF for cervical radiculopathy from de- result in better outcomes (clinical generative disorders at an average of 34 months fol- or radiographic) than ACDF with- low up, although it does appear to improve sagittal out instrumentation? alignment. Mobbs et al8 described a retrospective compara- RECOMMENDATION: Both ACDF with and tive study comparing clinical and radiographic out- without a plate are suggested as comparable comes of ACDF with ACDFP in patients with cervi- treatment strategies, producing similar clinical cal radiculopathy. Of the 212 radiculopathy patients outcomes and fusion rates, in the treatment of included in the study, 116 received ACDF and 96 single level cervical radiculopathy from degen- were treated with ACDFP. Using Odom’s criteria, erative disorders. there was no significant difference in good to excellent outcomes between the two groups (87% of the GRADE OF RECOMMENDATION: B ACDF patient group and 92% of the ACDFP). On the other hand, the noninstrumented group had a Grob et al5 conducted a prospective randomized statistically significantly higher frequency of poor controlled trial comparing clinical and radiographic outcomes at 7% (8/116) compared to the ACDFP outcomes of ACDF and ACDFP. Of the 50 patients group at 1% (1/96). Poor outcomes were considered available at follow-up, 24 were randomized to ACD- to be postoperative kyphosis and nonunion. The au- FP and 26 to ACDF. Both groups had a statistically thors concluded that excellent results were similar significant decrease in VAS pain scores and improve- for both groups. There was a significantly higher rate ment in cervical spine range of motion postopera- of poor outcomes in the uninstrumented group and tively, but there was no significant difference be- this lead to higher rate of second surgery.

In critique, no validated outcome measures were ment in cervical spine range of motion postopera- used and the length of follow-up was short. This tively, but there was no significant difference be- study provides Level III evidence that addition of an tween groups for either of these outcome measures. anterior locking plate may not lead to an increased Radiographically, there was no difference in the fre- likelihood of a satisfactory clinical outcome, but it quency of pseudoarthrosis/nonunion. The authors may lower the likelihood of a poor outcome and defined inferior “graft quality” as ventral graft dislo- need for reoperation. cation greater than 2mm and/or loss of disc height by more than 2mm. Based upon these criteria, the Zoega et al16 reported results of a prospective ran- plate group had significantly better results (p=.04). domized controlled trial evaluating whether the ad- The authors concluded that addition of an anterior dition of a plate to a single level cervical fusion for cervical plate did not lead to an improved clinical degenerative disc disease enhances fusion rate and outcome for patients treated for cervical radiculopa- contributes to maintaining alignment. Of the 27pa- thy with a one or two level anterior procedure. tients included in the study, 15 were assigned to the ACDFP group and 12 to the ACDF group. There was In critique, patients were not masked to treatment a statistically significant increase in the frequency group and no validated outcome measures were of postoperative kyphosis in the nonplated group at utilized to assess this small sample of patients. The one year follow-up (p=.04). At two years statistical authors did not indicate that the patients were con- significance was lost (p=>06). There was one non- secutively assigned and utilized a questionable ran- union in the plate group; none in the ACDF group. domization method. Due to these limitations, this Clinical scores were the same for both groups. The potential Level I study provides Level II evidence that authors concluded that the plate maintains align- the addition of a plate does not improve outcomes ment, but provides no advantage for healing or for following ACDF for cervical radiculopathy from de- clinical outcomes generative disorders at an average of 34 months follow up, although it does appear to improve sagittal In critique, neither patients nor reviewers were alignment. masked to treatment group. No validated outcome measures were utilized in this small sample of pa- Mobbs et al8 described a retrospective compara- tients. Due to these limitations, this potential Level I tive study comparing clinical and radiographic study provides Level II evidence that the addition of outcomes of ACDF with ACDFP in patients with a plate to ACDF maintains alignment. cervical radiculopathy. Of the 212 radiculopathy patients included in the study, 116 received ACDF RECOMMENDATION: The addition of a cervi- and 96 were treated with ACDFP. Using Odom’s cri- cal plate is suggested to improve sagittal align- teria, there was no significant difference in good to ment following ACDF. excellent outcomes between the two groups (87% of the ACDF patient group and 92% of the ACDFP). GRADE OF RECOMMENDATION: B On the other hand, the uninstrumented group had a statistically significantly higher frequency of poor Grob et al5 conducted a prospective randomized outcomes at 7% (8/116) compared to the ACDFP controlled trial comparing clinical and radiographic group at 1% (1/96). Poor outcomes were considered outcomes of ACDF and ACDFP. Of the 50 patients to be postoperative kyphosis and nonunion. The au- available at follow-up, 24 were randomized to ACD- thors concluded that excellent results were similar FP and 26 to ACDF. Both groups had a statistically for both groups. There was a significantly higher rate significant decrease in VAS pain scores and improve- of poor outcomes in the uninstrumented group and this lead to higher rate of second surgery.

In critique, no validated outcome measures were for a future study which would generate meaning- used and the length of follow-up was short. This ful evidence to assist in further defining the role of study provides Level III evidence that addition of an instrumentation in addition to ACDF in the surgical anterior locking plate may not lead to an increased treatment of cervical radiculopathy from degenera- likelihood of a satisfactory clinical outcome, but it tive disorders. may lower the likelihood of a poor outcome and need for reoperation. A well designed, prospective RCT to compare radiographic and clinical outcomes following ACDF with Zoega et al16 reported results of a prospective ran- or without a plate for degenerative cervical radicu- domized controlled trial evaluating whether the ad- lopathy would generate meaningful data regarding dition of a plate to a single level cervical fusion for the potential long term benefits of preserving or degenerative disc disease enhances fusion rate and restoring sagittal alignment. There should be two contributes to maintaining alignment. Of the 27pa- cohorts, one with single level disease, and one with tients included in the study, 15 were assigned to the multilevel disease. ACDFP group and 12 to the ACDF group. There was a statistically significant increase in the frequency References of postoperative kyphosis in the nonplated group at 1. Alvarez JA, Hardy RW. Anterior cervical discectomy for one year follow-up (p=.04). At two years statistical one- and two-level cervical disc disease: the controversy surrounding the question of whether to fuse, plate, or significance was lost (p=>06). There was one non- both. Crit Rev Neurosurg. Jul 1999;9(4):234-251. union in the plate group; none in the ACDF group. 2. Bolesta MJ, Rechtine GR, 2nd, Chrin AM. One- and two- Clinical scores were the same for both groups. The level anterior cervical discectomy and fusion: the effect of authors concluded that the plate maintains align- plate fixation. Spine J. May-Jun 2002;2(3):197-203. ment, but provides no advantage for healing or for 3. Caspar W, Geisler FH, Pitzen T, Johnson TA. Anterior cervical plate stabilization in one- and two-level degenera- clinical outcomes. tive disease: overtreatment or benefit?J Spinal Disord. Feb In critique, neither patients nor reviewers were 1998;11(1):1-11. masked to treatment group. No validated outcome 4. Connolly PJ, Esses SI, Kostuik JP. Anterior cervical fusion: measures were utilized in this small sample of pa- outcome analysis of patients fused with and without an- tients. Due to these limitations, this potential Level I terior cervical plates. J Spinal Disord. Jun 1996;9(3):202- 206. study provides Level II evidence that the addition of 5. Grob D, Peyer JV, Dvorak J. The use of plate fixation in a plate to ACDF maintains alignment. anterior surgery of the degenerative cervical spine: a comparative prospective clinical study. Eur Spine J. Oct RECOMMENDATION: While plate stabilization 2001;10(5):408-413. may be indicated in some patients undergoing 6. Kaiser MG, Haid RW, Jr., Subach BR, Barnes B, Rodts GE, Jr. Anterior cervical plating enhances arthrodesis after dis- multilevel ACDF, there is insufficient evidence cectomy and fusion with cortical allograft. Neurosurgery. that this practice results in significant improve- Feb 2002;50(2):229-236; discussion 236-228. ment in clinical outcomes for degenerative cer- 7. McLaughlin MR, Purighalla V, Pizzi FJ. Cost advantages vical radiculopathy. of two-level anterior cervical fusion with rigid internal Work Group Consensus Statement fixation for radiculopathy and degenerative disease. Surg Neurol. Dec 1997;48(6):560-565. 8. Mobbs RJ, Rao P, Chandran NK. Anterior cervical discec- A systematic review of the literature yielded no stud- tomy and fusion: analysis of surgical outcome with and ies to adequately compare outcomes for ACDF with without plating. J Clin Neurosci. Jul 2007;14(7):639-642. and without a plate for multilevel surgeries. 9. Nabhan A, Pape D, Pitzen T, et al. Radiographic analysis of fusion progression following one-level cervical fusion with or without plate fixation. Zentralbl Neurochir. Aug Future Directions for Research 2007;68(3):133-138. The work group identified the following suggestion

10. Resnick DK, Trost GR. Use of ventral plates for cervical arthrodesis. Neurosurgery. Jan 2007;60(1 Supp1 1):S112- Herkowitz et al7 reported results of a prospective 117. study comparing ACDF to posterior laminoforami- 11. Samartzis D, Shen FH, Lyon C, Phillips M, Goldberg EJ, An HS. Does rigid instrumentation increase the fusion rate in notomy (PLF). Of the 33 radiculopathy patients in- one-level anterior cervical discectomy and fusion? Spine J. cluded in the study, 17 were treated with ACDF and Nov-Dec 2004;4(6):636-643. 16 with PLF. The average age of the patients assigned 12. Troyanovich SJ, Stroink AR, Kattner KA, Dornan WA, Gu- to the ACDF group was 43, while the average age of bina I. Does anterior plating maintain cervical lordosis the patients assigned to the PLF group was 39. Of versus conventional fusion techniques? A retrospective analysis of patients receiving single-level fusions. J Spinal the ACDF patients, 94% reported good (5/17) or ex- Disord Tech. Feb 2002;15(1):69-74. cellent (11/17) results. Of the PLF patients, 75% re- 13. Wang JC, McDonough PW, Endow K, Kanim LE, Delama- ported good (6/16) or excellent (6/16) results. ACDF rter RB. The effect of cervical plating on single-level ante- was not significantly better (p<0.175). Osteophytic rior cervical discectomy and fusion. J Spinal Disord. Dec changes were seen in 9/17 ACDF patients and 8/16 1999;12(6):467-471. 14. Wang JC, McDonough PW, Endow KK, Delamarter RB. PLF patients. The authors concluded that both sur- Increased fusion rates with cervical plating for two-lev- gical procedures are effective, but ACDF tends to be el anterior cervical discectomy and fusion. Spine. Jan better over the long term. 2000;25(1):41-45. 15. Wang JC, McDonough PW, Kanim LE, Endow KK, Dela- In critique, neither patients nor reviewers were marter RB. Increased fusion rates with cervical plating for three-level anterior cervical discectomy and fusion. Spine. masked to treatment group and the randomization Mar 15 2001;26(6):643-646; discussion 646-647. technique employed was questionable. No validat- 16. Zoega B, Karrholm J, Lind B. One-level cervical spine fu- ed outcome measures were utilized to assess this sion. A randomized study, with or without plate fixation, small patient sample. Due to these limitations, this using radiostereometry in 27 patients. Acta Orthop Scand. potential Level II study provides Level III evidence Aug 1998;69(4):363-368. 17. Zoega B, Karrholm J, Lind B. Plate fixation adds stabil- that ACD with fusion and posterior laminoforami- ity to two-level anterior fusion in the cervical spine: a notomy appear equally effective in improving pain randomized study using radiostereometry. Eur Spine J. and weakness. 1998;7(4):302-307. Korinth et al8 described a retrospective compara- Does anterior surgery result in tive study comparing clinical results of anterior and posterior surgery for cervical radiculopathy due to better outcomes (clinical or ra- soft disc herniation. Of the 363 patients included in diographic) than posterior sur- the study, 154 were treated with ACDF using PMMA for median or paramedian discs and 209 received gery in the treatment of cervical PLF for posterolateral or foraminal discs, and 80% radiculopathy from degenerative (292/363: 124/154 ACDF, 168/209 PLF) were available for long term follow-up via clinical outpatient disorders? examination (14.7%), questionnaire (64.4%), and/or a telephone interview (20.9%). RECOMMENDATION: Either ACDF or PLF are suggested for the treatment of single level de- Complication rates, primarily related to hoarseness generative cervical radiculopathy secondary to and dysphagia, were reported in 6.5 % of ACDF pa- foraminal soft disc herniation to achieve com- tients and 1.8% of PLF patients. Reoperation rates parably successful clinical outcomes. were reported as 2.4% for the ACDF group and 7.1% for the PLF group. Mean operating time in the ACDF GRADE OF RECOMMENDATION: B

group was 112 minutes and 94.1 minutes for the in the study, 22 were assigned to the PLF group, 25 PLF group ( p<0.000). Of the patients in the ACDF to ACD and 25 to ACDF. Age, gender and duration group, 93.6% (116/124) reported good (36.3%) or of symptoms were similar for all groups. Although excellent (59.5%) results according to Odom’s crite- not specifically stated, follow-up was inclusive. An- ria and 0.8% reported poor results (p<0.05). Of the esthesia time, hospital stay, charges and analgesics patients in the PLF group, 85.1% (142/168) reported were similar. Pain improvement was reported by good (25.6%) or excellent (59.5%) results accord- more than 96% of patients in all groups. It appears ing to Odom’s criteria and 7.2% reported poor re- that all groups had similar outcomes. Return-to- sults (p<0.05). In the ACDF group, a pure soft disc work was reported as greater than 88% in all groups was removed in 60 cases (48.4%) and a mixture of and there was similar incidence of new weakness both hard and soft disc elements was removed in 64 and new numbness across all groups. Reoperation (51.6%). In the PLF group, a pure soft disc was re- rate were reported as 27% for the PLF group, 12% moved in 148 cases (88.1%) and a mixture of both for ACD and 28% for ACDF. The authors concluded hard and soft disc elements was removed in 20 cases that although the numbers in this study were small, (11.9%) (p<0.000). Soft disc herniations did not have none of the procedures could be considered supe- significantly better outcomes than the mixture of rior to the others. This study suggests that the selec- soft and hard disc, although there appeared to be a tion of surgical procedure may reasonably be based trend. In general, shorter duration of preoperative on the preference of the surgeon and tailored to the symptoms correlated with improved outcomes. The individual patient. authors concluded that anterior surgery yielded sta- In critique, neither patients nor reviewers were tistically superior outcomes, but both were effective. masked to the treatment group and no validated The findings show a higher success rate with ante- outcome measures were utilized. The functional rior microdiscectomy with PMMA interbody stabili- outcome tools were broad and subjective. The initial zation for treatment of degenerative cervical mono- clinical visit occurred at two months; the 60 month radiculopathy compared with PLF. follow-up was poorly coordinated and varied. Num- bers were small with poor statistical analysis. Due to In critique, no validated outcome measures were these limitations, this potential Level II study pro- utilized and there was a tendency for patient se- vides Level III evidence that ACD, ACDF and PLF lection to posterior procedure for more lateral disc result in comparable clinical outcomes in the treat- herniations, whereas for paramedian and central ment of cervical radiculopathy from unilateral disc herniations, there was an anterior bias. This study herniation. excluded patients with pure hard discs and pure foraminal stenosis. This study provides Level III RECOMMENDATION: Compared to PLF, ACDF evidence that patients improve with both PLF and is suggested for the treatment of single level de- ACDF, but ACDF results in statistically significantly generative cervical radiculopathy from central better outcomes. However, ACDF is associated with and paracentral nerve root compression and a higher risk of complications, primarily related to spondylotic disease. dysphagia/hoarseness. PLF is associated with a Work Group Consensus Statement higher reoperation rate. Future Directions for Research Wirth et al12 reported results of a prospective ran- The work group identified the following suggestion domized controlled trial comparing clinical out- for a future study which would generate meaning- comes for surgery for unilateral disc herniation ful evidence to assist in further defining the roles of causing radiculopathy. Of the 72 patients included PLF and ACDF in the surgical treatment of cervical

References 1. An HS, Ahn NU. Posterior decompressive procedures for Does posterior decompression the cervical spine. Instr Course Lect. 2003;52:471-477. with fusion result in better out- 2. Caglar YS, Bozkurt M, Kahilogullari G, et al. Keyhole approach for posterior cervical discectomy: experience on comes (clinical or radiographic) 84 patients. Minim Invasive Neurosurg. Feb 2007;50(1):7- 11. than posterior decompression 3. Chesnut RM, Abitbol JJ, Garfin SR. Surgical management of cervical radiculopathy. Indication, techniques, and re- alone in the treatment of cervical sults. Orthop Clin North Am. Jul 1992;23(3):461-474. 4. Davis RA. A long-term outcome study of 170 surgically radiculopathy from degenerative treated patients with compressive cervical radiculopathy. disorders? Surg Neurol. Dec 1996;46(6):523-530; discussion 530-523. 5. Dubuisson A, Lenelle J, Stevenaert A. Soft cervical disc herniation: a retrospective study of 100 cases. Acta Neuro- A systematic review of the literature yielded no stud- chir (Wien). 1993;125(1-4):115-119. ies to adequately compare the outcomes of posterior 6. Grieve JP, Kitchen ND, Moore AJ, Marsh HT. Results of decompression with posterior decompression with posterior cervical foraminotomy for treatment of cer- fusion in the treatment of cervical radiculopathy vical spondylitic radiculopathy. Br J Neurosurg. Feb from degenerative disorders. Most decompression 2000;14(1):40-43. 7. Herkowitz HN, Kurz LT, Overholt DP. Surgical manage- and fusion appears to be indicated for multilevel ment of cervical soft disc herniation. A comparison be- stenosis resulting in myelopathy or for instability tween the anterior and posterior approach. Spine. Oct due to trauma, tumor, or inflammatory disease. Due 1990;15(10):1026-1030. to limited indications and thus limited sample size, 8. Korinth MC, Kruger A, Oertel MF, Gilsbach JM. Posterior there is likely little to gain and a low probability of foraminotomy or anterior discectomy with polymethyl methacrylate interbody stabilization for cervical soft disc generating meaningful data to compare effects of disease: results in 292 patients with monoradiculopathy. posterior decompression alone to posterior decom- Spine. May 15 2006;31(11):1207-1214; discussion 1215- pression and fusion for degenerative disease result- 1206. ing in cervical radiculopathy. 9. Riew KD, Cheng I, Pimenta L, Taylor B. Posterior cervical spine surgery for radiculopathy. Neurosurgery. Jan 2007;60(1 Supp1 1):S57-63. Future Directions for Research 10. Rodrigues MA, Hanel RA, Prevedello DM, Antoniuk The study of posterior decompression and fusion A, Araujo JC. Posterior approach for soft cervical disc for radiculopathy appears inappropriate. While this herniation: a neglected technique? Surg Neurol. Jan procedure may be indicated occasionally, there will 2001;55(1):17-22; discussion 22. not be enough data to study results effectively, and 11. Ruetten S, Komp M, Merk H, Godolias G. A new full- endoscopic technique for cervical posterior foraminotomy it would not be an appropriate arm of a randomized

study. Thus the workgroup would not recommend but no significant difference was seen at 24 months further pursuit of this question. (p=0.638). NDI improved from baseline for each group (p<0.0001); however, between groups there References was a significant difference at three months for TDA 1. Epstein NE. Technical note: unilateral posterior resection (p<0.05) but not at 24 months (p=1.0000). This was of cervical disc and spondylostenosis with contralateral also true for aggregate patients who had greater fusion for instability. Surg Neurol. Oct 2001;56(4):256- 258. than a 15 point improvement. Secondary surgical 2. Rhee JM, Yoon T, Riew KD. Cervical radiculopathy. J Am procedures were performed in 1.9% of TDA patients Acad Orthop Surg. Aug 2007;15(8):486-494. and 8.5% of ACDF patients. Implant revision was 3. Scheufler KM, Kirsch E. Percutaneous multilevel decom- required in 4.7% of the ACDF patients, with 2.8% of pressive laminectomy, foraminotomy, and instrumented the ACDF patients requiring supplemental fixation, fusion for cervical spondylotic radiculopathy and myelopathy: assessment of feasibility and surgical technique. while no TDA patients required revision. VAS neck J Neurosurg Spine. Nov 2007;7(5):514-520. pain, arm pain frequency and intensity were similar for TDA and ACDF patients at 24 months.

Does ACD and reconstruction Success, as defined by greater than 20% improve- with total disc replacement result ment in VAS scores, was reported for 87.9% of TDA patients and 86.9% of ACDF patients at 24 months. in better outcomes (clinical or At 24 months, 80.8% of TDA patients and 74.4% of radiographic) than ACDF in the ACDF patients had successful outcomes as assessed by the SF-36 physical component summary. The SF- treatment of cervical radiculopa- 36 mental component summary showed 71.8% of thy from degenerative disorders? TDA and 68.9% of ACDF patients were successful. Patient satisfaction, narcotic use and adverse events RECOMMENDATION: ACDF and total disc ar- were similar for both groups. The authors concluded throplasty (TDA) are suggested as comparable that TDA for single level disease is safe and effective treatments, resulting in similarly successful and at least as good as ACDF. short term outcomes, for single level degenerative cervical radiculopathy. In critique, neither patients nor reviewers were masked to treatment group. This study provides Lev- GRADE OF RECOMMENDATION: B el I evidence that TDA shows equivalent outcomes to ACDF at two years for treatment of cervical radic- Murrey et al6 conducted a prospective randomized ulopathy due to single level disease. controlled trial comparing safety and efficacy of TDA to ACDF for single level symptomatic cervical Nabhan et al7 reported results of a prospective ran- disc disease with radiculopathy. Of the 209 patients domized controlled trial comparing radiographic included in the study, 106 were assigned to the and clinical results of TDA to ACDF. Of the 49 pa- ACDF group and 103 to TDA. There was no differ- tients included in the study, 25 were assigned to TDA ence in demographics between the TDA and ACDF and 24 to ACDF; however, only 20 TDA and 21 ACDF groups. Follow-up rates were 98% for TDA and 94% patients could be measured due to artifact. Range of for ACDF. ACDF had statistically significantly lower motion decreased in both groups. In the TDA group, smaller blood loss and operative time (although average motion decreased from 2.3 at one week to differences small). Neurological improvement was 0.8 at 52 weeks; in ACDF, it decreased from 0.6 at better for TDA than ACDF at six months (p<0.05), one week to 0.1 at 52 weeks. Comparison between

groups showed that the motion was significantly less and TDA in the treatment of cervical radiculopathy in the ACDF group for all time points except three from degenerative disorders. weeks. Preoperatively, there was no statistical difference in symptoms between both groups (P=0.1), as Recommendation #1: measured by the VAS. Both groups showed the same Continued long term follow-up of patients currently pattern of pain relief in arm pain at all examination enrolled in previously reported RCTs is necessary times without a statistically significant difference to determine if purported advantages of TDA com- (P=0.13). The ACDF group showed a higher- post pared with ACDF can be validated, with particular surgical resolving ratio in neck pain relief at three focus on validated clinical outcomes, revision sur- weeks, although without any statistically significant gery and adjacent segment disease. Subgroup anal- differences (P=0.09). The authors concluded that ysis should include soft disc compared with hard disc motion was maintained by TDA at one year and disc and foraminal compared with paracentral pa- was greater than ACDF, with similar clinical results thology for cervical radiculopathy patients. to ACDF. Recommendation #2: In critique, neither patients nor reviewers were Additional independent, masked, prospective RCTs masked to treatment group. No validated outcome comparing ACDF to TDA for the treatment of cer- measures were used and the sample size was small. vical radiculopathy from degenerative disorders The study utilized a good radiographic analysis tool, would add substantial unbiased validation to the re- but investigators chose neutral and extreme exten- sults of the investigational device exemption (IDE) sion and lateral rotation for their motion analysis. studies. Clinical evaluation was limited and was not the emphasis. Follow-up was only one year. Also the au- References thors concluded that motion was maintained with 1. Anderson PA, Sasso RC, Riew KD. Comparison of adverse TDA; however, the data demonstrate that it was not. events between the Bryan artificial cervical disc and anterior cervical arthrodesis. Spine. 2008:1305-1312. Range of motion was decreased, but significantly 2. Bartels RH, Donk R, van der Wilt GJ, Grotenhuis JA, Ven- greater than with ACDF. Due to these limitations, derink D. Design of the PROCON trial: a prospective, ran- this potential Level I study provides Level II evidence domized multi-center study comparing cervical anterior that compared with ACDF, patients treated with TDA discectomy without fusion, with fusion or with arthro- have statistically significantly greater range of mo- plasty. BMC Musculoskelet Disord. 2006;7:85. 3. Heidecke V, Burkert W, Brucke M, Rainov NG. Interverte- tion. Clinical outcomes are similar for both groups. bral disc replacement for cervical degenerative disease-- clinical results and functional outcome at two years in pa- There were several additional studies reviewed, tients implanted with the Bryan cervical disc prosthesis. some of them of high quality, that could not be in- Acta Neurochir (Wien). May 2008;150(5):453-459; discus- cluded in this guideline due to confounding of my- sion 459. 4. Kim SW, Limson MA, Kim SB, et al. Comparison of ra- elopathy grouped with radiculopathy. Due to lack of diographic changes after ACDF versus Bryan disc ar- subgroup analyses in these studies, no conclusions throplasty in single and bi-level cases. Euro Spine J. Feb could be reached in regards to outcomes in patients 2009;18(2):218-231. with cervical radiculopathy from degenerative dis- 5. Mummaneni PV, Burkus JK, Haid RW, Traynelis VC, Zde- orders. blick TA. Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine. Mar Future Directions for Research 2007;6(3):198-209. The work group identified the following suggestions 6. Murrey D, Janssen M, Delamarter R, et al. Results of the for future studies which would generate meaningful prospective, randomized, controlled multicenter Food evidence to assist in comparing outcomes of ACDF and Drug Administration investigational device exemp-

tion study of the ProDisc-C total disc replacement ver- level disease, ACD with PMMA interbody spacer re- sus anterior discectomy and fusion for the treatment of sults in 77% of patients reporting satisfactory clini- 1-level symptomatic cervical disc disease. Spine J. Apr cal outcomes at 10 to 15 years following surgery. 2009;9(4):275-286. 7. Nabhan A, Ahlhelm F, Shariat K, et al. The ProDisc-C prothesis - Clinical and radiological experience 1 year after Heidecke et al8 reported a case series reviewing out- surgery. Spine. Aug 2007;32(18):1935-1941. comes of Cloward-type fusion at mean follow-up of 8. Sasso RC, Smucker JD, Hacker RJ, Heller JG. Artificial disc 6.5 years. Of the 28 radiculopathy patients included, versus fusion: a prospective, randomized study with 2-year long term outcome was reported as good for 93% and follow-up on 99 patients. Spine. Dec 15 2007;32(26):2933- 2940; discussion 2941-2932. fair for 7%. No poor results were reported. Adverse events were dominated by graft site complications. The authors concluded that Cloward ACDF is a reli- What is the long-term result (four+ able and safe procedure for single level disease. years) of surgical management of In critique, no validated outcome measures were cervical radiculopathy from de- used in the study including a small sample of radic- generative disorders? ulopathy patients. This study provides Level IV evidence that for treatment of cervical radiculopathy RECOMMENDATION: Surgery is an option for due to degenerative disease, ACDF with Cloward the treatment of single level degenerative ra- technique results in 93% satisfactory results with diculopathy to produce and maintain favorable long term (4-10 year) follow-up. long term (greater than four year) outcomes. Jagannathan et al11 presented findings from a -ret GRADE OF RECOMMENDATION: C rospective case series reviewing results of PLF for treatment of single level cervical radiculopathy. Of Hamburger et al7 described a retrospective case se- the 212 cervical radiculopathy patients included in ries reviewing results of ACD with PMMA. Of the the study, long term outcomes were reported at a 319 cervical radiculopathy patients included in the mean of 78 months for the 162 patients. While NDI study, 249 were available for final follow-up at a mean improved in 93% of patients, 20% developed kypho- of 12.2 years. Of the 249 patients available for final sis. Patients who developed kyphosis reported worse follow-up, 246 had single level and 3 had two level results overall. During the follow-up period, 3.1% surgery. Good or excellent results were reported by (5/162) required additional procedures; two had 87% of patients. Lumbar symptoms and high occu- progression of disease at the index level, two devel- pational stress were correlated with clinical failure. oped stenosis and one developed “instability.” The Patients with soft disc herniations reported the best authors concluded that PLF is highly successful for results. Relatively worse outcomes were reported treating cervical radiculopathy. This study provides when “patients had unclear preoperative findings.” Level IV evidence that posterior laminoforaminoto- The authors concluded that ACD with PMMA isa my for the treatment of cervical radiculopathy due to safe and reliable method for treating monosegmen- degenerative disease results in significant improve- tal radiculopathy with outcomes and complication ment in 93% of cases at 5-15 year follow-up. There rates similar to other published studies. may be a trend for patients older than 60 years with initial lordosis of less than 10 degrees to be more In critique, no validated outcome measures were vulnerable to development of postoperative cervi- used. This study provides Level IV evidence that for cal kyphosis or translational deformity, though the the treatment of cervical radiculopathy due to single clinical significance of this is uncertain.

Wirth et al21 reported results of a prospective ran- An adequately powered, prospective, comparative domized controlled trial comparing clinical out- study of patients treated with ACDF, ACD, TDA and comes for surgery for unilateral disc herniation PLF followed for greater than four years and assessed causing radiculopathy. Of the 72 patients included with validated outcome measures would yield use- in the study, 22 were assigned to the PLF group, 25 ful information about the long term outcomes of to ACD and 25 to ACDF. Age, gender and duration surgery for cervical radiculopathy from degenera- of symptoms were similar for all groups. Although tive disorders. not specifically stated, follow-up was inclusive. An- esthesia time, hospital stay, charges and analgesics References were similar. Pain improvement was reported by 1. Bertalanffy H, Eggert HR. Clinical long-term results of an- more than 96% of patients in all groups. It appears terior discectomy without fusion for treatment of cervical radiculopathy and myelopathy. A follow-up of 164 cases. that all groups had similar outcomes. Return-to- Acta Neurochir (Wien). 1988;90(3-4):127-135. work was reported as greater than 88% in all groups 2. Cornelius JF, Bruneau M, George B. Microsurgical cervical and there was similar incidence of new weakness nerve root decompression via an anterolateral approach: and new numbness across all groups. Reoperation Clinical outcome of patients treated for spondylotic radic- rates were reported as 27% for the PLF group, 12% for ulopathy. Neurosurgery. Nov 2007;61(5):972-980. 3. Davis RA. A long-term outcome study of 170 surgically ACD and 28% for ACDF. Of the 72 patients included treated patients with compressive cervical radiculopathy. in the study, 60% [13/25 (52%) for ACD, 16/25 (64%) Surg Neurol. Dec 1996;46(6):523-530; discussion 530-523. for ACDF, and 14/22 (64%) for PLF] were available 4. Gaetani P, Tancioni F, Spanu G, Rodriguez y Baena R. Ante- for final follow-up at a mean of 60 months via tele- rior cervical discectomy: an analysis on clinical long-term phone interview or clinic visit. The authors conclud- results in 153 cases. J Neurosurg Sci. Dec 1995;39(4):211- 218. ed that ACD, ACDF or PLF are reasonable surgical 5. Goffin J, Geusens E, Vantomme N, et al. Long-term follow- choices for cervical radiculopathy due to unilateral up after interbody fusion of the cervical spine. J Spinal disc herniation. Disord Tech. Apr 2004;17(2):79-85. 6. Goldberg EJ, Singh K, Van U, Garretson R, An HS. Com- In critique, neither patients nor reviewers were paring outcomes of anterior cervical discectomy and fusion in workman’s versus non-workman’s compensation masked to the treatment group and no validated population. Spine J. Nov-Dec 2002;2(6):408-414. outcome measures were utilized. The functional 7. Hamburger C, Festenberg FV, Uhl E. Ventral discectomy outcome tools were broad and subjective. The initial with pmma interbody fusion for cervical disc disease: long- clinical visit occurred at two months; the 60 month term results in 249 patients. Spine. Feb 1 2001;26(3):249- follow-up was poorly coordinated and varied. Num- 255. 8. Heidecke V, Rainov NG, Marx T, Burkert W. Outcome in bers were small with poor statistical analysis and Cloward anterior fusion for degenerative cervical spinal 40% were lost to follow-up. Due to these limita- disease. Acta Neurochir (Wien). 2000;142(3):283-291. tions, this potential Level II study provides Level III 9. Hida K, Iwasaki Y, Yano S, Akino M, Seki T. Long-term evidence that for unilateral radiculopathy caused by follow-up results in patients with cervical disk disease CDH, ACD, ACDF or PLF result in satisfactory out- treated by cervical anterior fusion using titanium cage implants. Neurol Med Chir (Tokyo). Oct 2008;48(10):440-446; comes at five year follow-up. discussion 446. 10. Hilibrand AS, Carlson GD, Palumbo MA, Jones PK, Bohl- Future Directions for Research man HH. Radiculopathy and myelopathy at segments ad- The work group identified the following suggestion jacent to the site of a previous anterior cervical arthrod- for future studies which would generate meaningful esis. J Bone Joint Surg Am. Apr 1999;81(4):519-528. 11. Jagannathan J, Sherman JH, Szabo T, Shaffrey CI, Jane JA. evidence to assist in comparing long term outcomes The posterior cervical foraminotomy in the treatment of of various surgical procedures to assist in defining cervical disc/osteophyte disease: a single-surgeon experi- their role in the treatment of cervical radiculopathy ence with a minimum of 5 years’ clinical and radiographic from degenerative disorders.

follow-up. J Neurosurg Spine. Apr 2009;10(4):347-356. How do long-term results of single- 12. Kadoya S, Iizuka H, Nakamura T. Long-term outcome for surgically treated cervical spondylotic radiculopathy and level compare with multilevel myelopathy. Neurol Med Chir (Tokyo). May 2003;43(5):228- 240; discussion 241. surgical decompression for cervical 13. Korinth MC, Kruger A, Oertel MF, Gilsbach JM. Posterior foraminotomy or anterior discectomy with polymethyl radiculopathy from degenerative methacrylate interbody stabilization for cervical soft disc disease: results in 292 patients with monoradiculopathy. disorders? Spine. May 15 2006;31(11):1207-1214; discussion 1215- 1206. A systematic review of the literature yielded no stud- 14. Matge G, Leclercq TA. Rationale for interbody fusion with ies to adequately address the comparison of long threaded titanium cages at cervical and lumbar levels. Re- term results of single-level compared with multi- sults on 357 cases. Acta Neurochir (Wien). 2000;142(4):425- 434. level surgical decompression in the management of 15. Peolsson A, Peolsson M. Predictive factors for long-term cervical radiculopathy from degenerative disorders. outcome of anterior cervical decompression and fusion: a After this review, it is clear that most patients with multivariate data analysis. Eur Spine J. Mar 2008;17(3):406- true radiculopathy suffer from one level and occa- 414. sionally two level disease. The incidence of multi- 16. Ramzi N, Ribeiro-Vaz G, Fomekong E, Lecouvet FE, Rafto- poulos C. Long term outcome of anterior cervical discec- level disease without the additional presence of my- tomy and fusion using coral grafts. Acta Neurochir (Wien). elopathy is rare. Thus, there is likely little to gain and Dec 2008;150(12):1249-1256; discussion 1256. a low probability of generating meaningful data to 17. Rao PJ, Christie JG, Ghahreman A, Cartwright CA, Ferch answer this question. RD. Clinical and functional outcomes of anterior cervical discectomy without fusion. J Clin Neurosci. December 2008;15(12):1354-1359. Future Directions for Research 18. Schneeberger AG, Boos N, Schwarzenbach O, Aebi M. The work group would not recommend further pur- Anterior cervical interbody fusion with plate fixation for suit of this question, but suggests limiting efforts to chronic spondylotic radiculopathy: a 2- to 8-year follow- collecting long term data in primarily single level up. J Spinal Disord. Jun 1999;12(3):215-220; discussion disease. 221. 19. Shapiro S, Connolly P, Donnaldson J, Abel T. Cadaveric fibula, locking plate, and allogeneic bone matrix for ante- References rior cervical fusions after cervical discectomy for radicu- 1. Bertalanffy H, Eggert HR. Clinical long-term results of an- lopathy or myelopathy. J Neurosurg. Jul 2001;95(1 Sup- terior discectomy without fusion for treatment of cervical pl):43-50. radiculopathy and myelopathy. A follow-up of 164 cases. 20. Sugawara T, Itoh Y, Hirano Y, Higashiyama N, Mizoi K. Long Acta Neurochir (Wien). 1988;90(3-4):127-135. term outcome and adjacent disc degeneration after ante- 2. Cornelius JF, Bruneau M, George B. Microsurgical cervical rior cervical discectomy and fusion with titanium cylin- nerve root decompression via an anterolateral approach: drical cages. Acta Neurochir (Wien). Apr 2009;151(4):303- Clinical outcome of patients treated for spondylotic radic- 309. ulopathy. Neurosurgery. Nov 2007;61(5):972-980. 21. Wirth FP, Dowd GC, Sanders HF, Wirth C. Cervical discec- 3. Gaetani P, Tancioni F, Spanu G, Rodriguez y Baena R. Ante- tomy. A prospective analysis of three operative techniques. rior cervical discectomy: an analysis on clinical long-term Surg Neurol. Apr 2000;53(4):340-346; discussion 346-348. results in 153 cases. J Neurosurg Sci. Dec 1995;39(4):211- 22. Yamamoto I, Ikeda A, Shibuya N, Tsugane R, Sato O. 218. Clinical long-term results of anterior discectomy with- 4. Goffin J, Geusens E, Vantomme N, et al. Long-term follow- out interbody fusion for cervical disc disease. Spine. Mar up after interbody fusion of the cervical spine. J Spinal 1991;16(3):272-279. Disord Tech. Apr 2004;17(2):79-85. 23. Zeidman SM, Ducker TB. Posterior cervical laminoforami- 5. Hamburger C, Festenberg FV, Uhl E. Ventral discectomy notomy for radiculopathy: review of 172 cases. Neurosur- with pmma interbody fusion for cervical disc disease: long- gery. Sep 1993;33(3):356-362. term results in 249 patients. Spine. Feb 1 2001;26(3):249- 255.

6. Heidecke V, Rainov NG, Marx T, Burkert W. Outcome in 11. Rao PJ, Christie JG, Ghahreman A, Cartwright CA, Ferch Cloward anterior fusion for degenerative cervical spinal RD. Clinical and functional outcomes of anterior cervi- disease. Acta Neurochir (Wien). 2000;142(3):283-291. cal discectomy without fusion. J Clin Neurosci. December 7. Kadoya S, Iizuka H, Nakamura T. Long-term outcome for 2008;15(12):1354-1359. surgically treated cervical spondylotic radiculopathy and 12. Shapiro S, Connolly P, Donnaldson J, Abel T. Cadaveric myelopathy. Neurol Med Chir (Tokyo). May 2003;43(5):228- fibula, locking plate, and allogeneic bone matrix for ante- 240; discussion 241. rior cervical fusions after cervical discectomy for radicu- 8. Korinth MC, Kruger A, Oertel MF, Gilsbach JM. Posterior lopathy or myelopathy. J Neurosurg. Jul 2001;95(1 Sup- foraminotomy or anterior discectomy with polymethyl pl):43-50. methacrylate interbody stabilization for cervical soft disc 13. Sugawara T, Itoh Y, Hirano Y, Higashiyama N, Mizoi K. Long disease: results in 292 patients with monoradiculopathy. term outcome and adjacent disc degeneration after ante- Spine. May 15 2006;31(11):1207-1214; discussion 1215- rior cervical discectomy and fusion with titanium cylin- 1206. drical cages. Acta Neurochir (Wien). Apr 2009;151(4):303- 9. Peolsson A, Peolsson M. Predictive factors for long-term 309. outcome of anterior cervical decompression and fusion: a 14. Yamamoto I, Ikeda A, Shibuya N, Tsugane R, Sato O. multivariate data analysis. Eur Spine J. Mar 2008;17(3):406- Clinical long-term results of anterior discectomy with- 414. out interbody fusion for cervical disc disease. Spine. Mar 10. Ramzi N, Ribeiro-Vaz G, Fomekong E, Lecouvet FE, Rafto- 1991;16(3):272-279. poulos C. Long term outcome of anterior cervical discec- 15. Zeidman SM, Ducker TB. Posterior cervical laminoforami- tomy and fusion using coral grafts. Acta Neurochir (Wien). notomy for radiculopathy: review of 172 cases. Neurosur- Dec 2008;150(12):1249-1256; discussion 1256. gery. Sep 1993;33(3):356-362.

ACD anterior cervical discectomy/ MMI Modified Million Index decompression MR magnetic resonance ACDF anterior cervical discectomy/ MRI magnetic resonance imaging decompression and fusion NASS North American Spine Society ACDFI anterior cervical discectomy/ NDI Neck Disability Index decompression and instrumented fusion NPS neurophysiologic studies ACDFP anterior cervical discectomy/ NPP negative predictive power decompression and fusion plus plate NSAIDs nonsteroidal anti-inflammatory drugs ADL activities of daily living ODI Oswestry Disability Index AROM active range of motion PEMF pulsed electromagnetic field C-TDR cervical total disc replacement PLF posterior laminoforaminotomy CDH cervical disc herniation PMMA polymethylmethacrylate CR cervical radiculopathy PPV positive predictive value CSR cervical spondylotic radiculopathy PSFS Patient Specific Functional Scale CT computed tomography RCT randomized clinical trial CTM computed tomography myelography ROM range of motion CTS carpal tunnel syndrome SF-12 12-Item Short Form Health Survey DTR deep tendon reflex SF-36 36-Item Short Form Health Survey EBM evidence-based medicine SIP Sickness Impact Profile EMG electromyography SNRB selective nerve root block GRE gradient recall echo TDA total disc arthroplasty HAD Hospital Anxiety and Depression TENS transcutaneous electrical nerve HNP herniated nucleus pulposus stimulation HSQ Health Status Questionnaire ULTT Upper Limb Tension Test ICBG iliac crest bone graft VAS Visual Analog Scale LFA limited flip angle ZDS Zung Depression Scale

Appendix B: Levels of Evidence For Primary Research Question1

Types of Studies Therapeutic Studies – Prognostic Studies – Diagnostic Studies – Economic and Decision Investigating the results of Investigating the effect of a Investigating a diagnostic Analyses – treatment patient characteristic on the test Developing an economic or outcome of disease decision model Level 1 • High quality randomized trial • High quality prospective • Testing of previously • Sensible costs and with statistically significant study4 (all patients were developed diagnostic alternatives; values obtained difference or no statistically enrolled at the same point criteria on consecutive from many studies; with significant difference but in their disease with ≥ patients (with universally multiway sensitivity analyses narrow confidence intervals 80% follow-up of enrolled applied reference “gold” • Systematic review2 of Level • Systematic review2 of Level patients) standard) I studies I RCTs (and study results • Systematic review2 of Level • Systematic review2 of were homogenous3) I studies Level I studies

Level II • Lesser quality RCT (eg, < • Retrospective6 study • Development of diagnostic • Sensible costs and 80% follow-up, no blinding, • Untreated controls from an criteria on consecutive alternatives; values obtained or improper randomization) RCT patients (with universally from limited studies; with • Prospective4 comparative • Lesser quality prospective applied reference “gold” multiway sensitivity analyses study5 study (eg, patients enrolled standard) • Systematic review2 of Level Systematic review2 of Level at different points in their • Systematic review2 of II studies II studies or Level 1 studies disease or <80% follow-up) Level II studies with inconsistent results • Systematic review2 of Level II studies

Level III • Case control study7 • Case control study7 • Study of nonconsecutive • Analyses based on limited • Retrospective6 comparative patients; without alternatives and costs; and study5 consistently applied poor estimates • Systematic review2 of Level reference “gold” standard • Systematic review2 of Level III studies • Systematic review2 of III studies Level III studies

Level IV Case series8 Case series • Case-control study • Analyses with no sensitivity • Poor reference standard analyses

Level V Expert opinion Expert opinion Expert opinion Expert opinion

1. A complete assessment of quality of individual studies re- 6. The study was started after the first patient enrolled. quires critical appraisal of all aspects of the study design. 7. Patients identified for the study based on their outcome, 2. A combination of results from two or more prior studies. called “cases” (eg, failed total arthroplasty) are compared 3. Studies provided consistent results. to those who did not have outcome, called “controls” (eg, 4. Study was started before the first patient enrolled. successful total hip arthroplasty). 5. Patients treated one way (eg, cemented hip arthroplasty) 8. Patients treated one way with no comparison group of pa- compared with a group of patients treated in another way tients treated in another way. (eg, uncemented hip arthroplasty) at the same institution.

Appendix C: Grades of Recommendation for Summaries or Reviews of Studies

A: Good evidence (Level I Studies with consistent findings) for or against recommending intervention.

B: Fair evidence (Level II or III Studies with consistent findings) for or against recommending intervention.

C: Poor quality evidence (Level IV or V Studies) for or against recommending intervention.

I: Insufficient or conflicting evidence not allowing a recommendation for or against intervention.

Appendix D: Protocol for NASS Literature Searches

One of the most crucial elements of evidence analy- Protocol for NASS Literature Searches sis to support development of recommendations for The NASS Research Department has a relationship appropriate clinical care or use of new technologies with Northwestern University’s Galter Health Sci- is the comprehensive literature search. Thorough as- ences Library. When it is determined that a litera- sessment of the literature is the basis for the review ture search is needed, NASS research staff will work of existing evidence, which will be instrumental to with the requesting parties and Galter to run a com- these activities. prehensive search employing at a minimum the following search techniques: Background It has become apparent that the number of litera- 1. A preliminary search of the evidence will be con- ture searches being conducted at NASS is increas- ducted using the following clearly defined search ing and that they are not necessarily conducted in parameters (as determined by the content experts). a consistent manner between committees/projects. The following parameters are to be provided to re- Because the quality of a literature search directly af- search staff to facilitate this search. fects the quality of recommendations made, a com-  Time frames for search parative literature search was undertaken to help  Foreign and/or English language NASS refine the process and make recommenda-  Order of results (chronological, by journal, etc.) tions about how to conduct future literature search-  Key search terms and connectors, with or with- es on a NASS-wide basis. out MeSH terms to be employed  Age range In November-December 2004, NASS conducted a  Answers to the following questions: trial run at new technology assessment. As part of ◆ Should duplicates be eliminated between the analysis of that pilot process, the same literature searches? searches were conducted by both an experienced ◆ Should searches be separated by term or as NASS member and a medical librarian for compari- one large package? son purposes. After reviewing the results of that ex- ◆ Should human studies, animal studies or ca- periment and the different strategies employed for daver studies be included? both searches, it was the recommendation of NASS Research Staff that a protocol be developed to en- This preliminary search should encompass a search sure that all future NASS searches be conducted of the Cochrane database when access is available. consistently to yield the most comprehensive results. While it is recognized that some searches oc- 2. Search results with abstracts will be compiled cur outside the Research and Clinical Care Councils, by Galter in Endnote software. Galter typically re- it is important that all searches conducted at NASS sponds to requests and completes the searches employ a solid search strategy, regardless of the within two to five days. Results will be forwarded to source of the request. To this end, this protocol has the research staff, who will share it with the appro- been developed and NASS-wide implementation is priate NASS staff member or requesting party(ies). recommended. (Research staff hasve access to EndNote software and will maintain a database of search results for future use/documentation.)

3. NASS staff shares the search results with an ap- 8. NASS members reviewing full-text articles propriate content expert (NASS Committee member should also review the references at the end of each or other) to assess relevance of articles and identify article to identify additional articles which should be appropriate articles to review and on which to run a reviewed, but may have been missed in the search. “related articles” search. Protocol for Expedited Searches 4. Based on content expert’s review, NASS research At a minimum, numbers 1, 2 and 3 should be fol- staff will then coordinate with the Galter medical lowed for any necessary expedited search. Follow- librarian the second level searching to identify rel- ing #3, depending on the time frame allowed, deeper evant “related articles.” searching may be conducted as described by the full protocol or request of full-text articles may occur. If 5. Galter will forward results to Research Staff to full-text articles are requested, #8 should also be in- share with appropriate NASS staff. cluded. Use of the expedited protocol or any devia- tion from the full protocol should be documented 6. NASS staff share related articles search results with explanation. with an appropriate content expert (NASS Commit- tee member or other) to assess relevance of this sec- Following these protocols will help ensure that NASS ond set of articles, and identify appropriate articles recommendations are (1) based on a thorough re- to review and on which to run a second “related ar- view of relevant literature; (2) are truly based on a ticles” search. uniform, comprehensive search strategy; and (3) represent the current best research evidence avail- 7. NASS research staff will work with Galter library able. Research staff will maintain a search history in to obtain the 2nd related articles search results and EndNote for future use or reference. any necessary full-text articles for review.

Appendix E: Literature Search Parameters

Natural History of Cervical Radiculopathy from Degenerative Disorders Search Strategies

Search Strategies by Clinical Question:

1. What is the best working definition of cervical radiculopathy from degenerative disorders?

Reviewed book chapters (see reference section).

2. What is the natural history of cervical radiculopathy from degenerative disoders?

((("Radiculopathy"[Mesh] OR "Polyradiculopathy"[Mesh] OR "Intervertebral Disk Displacement"[Mesh]) AND cervical[All Fields]) OR ("cervical radiculopathy"[All Fields] OR "cervical radiculitis"[All Fields] OR "cervical disc herniation"[All Fields])) AND degenerative[All Fields] AND ("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang]

Databases Searched:  MEDLINE (PubMed)  EMBASE  Web of Science  Cochrane Database of Systematic reviews  Cochrane Central Register of Controlled Trials

Diagnosis/Imaging of Cervical Radiculopathy from Degenerative Disorders Search Strategies

Search Strategies by Clinical Question: 1. What are the most appropriate historical and physical exam findings consistent with the diagnosis of cervical radiculopathy from degenerative disorders?

2. What are the most appropriate diagnostic tests for cervical radiculopathy from degenerative disorders?

Databases Searched:  MEDLINE (PubMed)  EMBASE  Web of Science  Cochrane Database of Systematic reviews  Cochrane Central Register of Controlled Trials

Outcome Measures for Cervical Radiculopathy from Degenerative Disorders Search Strategies

Search Strategies by Clinical Question: 1. What are the appropriate outcome measures for the treatment of cervical radiculopathy from degenerative disorders?

((("Radiculopathy"[All Fields] AND cervical[All Fields]) OR "cervical radiculopathy"[All Fields] OR "cervical radiculitis"[All Fields]) AND ("Intervertebral Disk Displacement"[Mesh] OR foraminal stenosis[All Fields] OR ("intervertebral disk degeneration"[MeSH Terms] OR ("intervertebral"[All Fields] AND "disk"[All Fields] AND "degeneration"[All Fields]) OR "intervertebral disk degeneration"[All Fields] OR ("disc"[All Fields] AND "degeneration"[All Fields]) OR "disc degeneration"[All Fields]) OR disk degeneration[All Fields] OR disk herniation[All Fields] OR disc herniation[All Fields] OR degenerative[All Fields]) AND (("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang])) AND (("outcome assessment (health care)"[MeSH Terms] OR ("outcome"[All Fields] AND "assessment"[All Fields] AND "(health"[All Fields] AND "care)"[All Fields]) OR "outcome assessment (health care)"[All Fields] OR ("outcome"[All Fields] AND "measure"[All Fields]) OR "outcome measure"[All Fields]) OR ("outcome assessment (health care)"[MeSH Terms] OR ("outcome"[All Fields] AND "assessment"[All Fields] AND "(health"[All Fields] AND "care)"[All Fields]) OR "outcome assessment (health care)"[All Fields] OR ("outcome"[All Fields] AND "measures"[All Fields]) OR "outcome measures"[All Fields]))

Databases Searched:  MEDLINE (PubMed)  EMBASE  Web of Science  Cochrane Database of Systematic reviews  Cochrane Central Register of Controlled Trials

Medical/Interventional Treatment of Cervical Radiculopathy from Degenerative Disorders Search Strategies

Search Strategies by Clinical Question: 1. What is the role of pharmacological treatment in the management of cervical radiculopathy from degenerative disorders?

2. What is the role of physical therapy/exercise in the treatment of cervical radiculopathy from degenerative disorders?

3. What is the role of manipulation/chiropractics in the treatment of cervical radiculopathy from degenerative disorders?

4. What is the role of epidural steroid injections for the treatment of cervical radiculopathy from degenerative disorders?

5. What is the role of ancillary treatments such as bracing, traction, electrical stimulation, acupuncture and transcutaneous electrical stimulation (TENS) in the treatment of cervical radiculopathy from degenerative disorders?

((("Radiculopathy"[All Fields] AND cervical[All Fields]) OR "cervical radiculopathy"[All Fields] OR "cervical radiculitis"[All Fields]) AND ("Intervertebral Disk Displacement"[Mesh] OR foraminal stenosis[All Fields] OR ("intervertebral disk degeneration"[MeSH Terms] OR ("intervertebral"[All Fields] AND "disk"[All Fields] AND "degeneration"[All Fields]) OR "intervertebral disk degeneration"[All Fields] OR ("disc"[All Fields] AND "degeneration"[All Fields]) OR "disc degeneration"[All Fields]) OR disk degeneration[All Fields] OR disk herniation[All Fields] OR disc herniation[All Fields] OR degenerative[All Fields]) AND (("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang])) AND ("Braces"[Mesh] OR "Traction"[Mesh] OR "Electric Stimulation"[Mesh] OR "Transcutane- ous Electric Nerve Stimulation"[Mesh] OR "Acupuncture Therapy"[Mesh] OR "Acupuncture"[Mesh] OR bracing[All Fields] OR ("braces"[MeSH Terms] OR "braces"[All Fields] OR "brace"[All Fields]) OR ("braces"[MeSH Terms] OR "braces"[All Fields]) OR ("traction"[MeSH Terms] OR "traction"[All Fields]) OR "electrical stimulation"[All Fields] OR ("transcutaneous electric nerve stimulation"[MeSH Terms] OR ("transcutaneous"[All Fields] AND "electric"[All Fields] AND "nerve"[All Fields] AND "stimulation"[All Fields]) OR "transcutaneous electric nerve stimulation"[All Fields] OR "tens"[All Fields]))

Databases Searched:  MEDLINE (PubMed)  EMBASE  Web of Science  Cochrane Database of Systematic reviews  Cochrane Central Register of Controlled Trials

Surgical Treatment of Cervical Radiculopathy from Degenerative Disorders Search Strategies

Search Strategies by Clinical Question 1. Does surgical treatment (with or without preoperative medical/interventional treatment) result in better outcomes than medical/interventional treatment for cervical radiculopathy from degenerative disorders?

2. Does anterior cervical decompression with fusion result in better outcomes (clinical or radiographic) than anterior cervical decompression alone?

((("Radiculopathy"[All Fields] AND cervical[All Fields]) OR "cervical radiculopathy"[All Fields] OR "cervical radiculitis"[All Fields]) AND ("Intervertebral Disk Displacement"[Mesh] OR foraminal stenosis[All Fields] OR ("intervertebral disk degeneration"[MeSH Terms] OR ("intervertebral"[All Fields] AND "disk"[All Fields] AND "degeneration"[All Fields]) OR "intervertebral disk degeneration"[All Fields] OR ("disc"[All Fields] AND "degeneration"[All Fields]) OR "disc degeneration"[All Fields]) OR disk degeneration[All Fields] OR disk herniation[All Fields] OR disc herniation[All Fields] OR degenerative[All Fields]) AND (("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang])) AND (("Decompression, Surgical"[Mesh] AND anterior[All Fields] AND cervical[All Fields]) OR (anterior[All Fields] AND cervical[All Fields] AND ("decompression"[MeSH Terms] OR "decompression"[All Fields]) OR (anterior[All Fields] AND cervical[All Fields] AND ("diskectomy"[MeSH Terms] OR "diskectomy"[All Fields] OR "discectomy"[All Fields]))) AND (("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang])) AND (("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang]) AND (("Nucl Eng Des/Fusion"[Journal] OR "fusion"[All Fields]) OR ("arthrodesis"[MeSH Terms] OR "arthrodesis"[All Fields]))

3. Does anterior cervical decompression and fusion with instrumentation result in better outcomes (clinical or radiographic) than anterior cervical decompression and fusion without instrumentation?

((("Radiculopathy"[All Fields] AND cervical[All Fields]) OR "cervical radiculopathy"[All Fields] OR "cervical radiculitis"[All Fields]) AND ("Intervertebral Disk Displacement"[Mesh] OR foraminal stenosis[All Fields] OR ("intervertebral disk degeneration"[MeSH Terms] OR ("intervertebral"[All Fields] AND "disk"[All Fields] AND "degeneration"[All Fields]) OR "intervertebral disk degeneration"[All Fields] OR ("disc"[All Fields] AND "degeneration"[All Fields]) OR "disc degeneration"[All Fields]) OR disk degeneration[All Fields] OR disk herniation[All Fields] OR disc herniation[All Fields] OR degenerative[All Fields]) AND (("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang])) AND (("Decompression, Surgical"[Mesh] AND anterior[All Fields] AND cervical[All Fields]) OR (anterior[All Fields] AND cervical[All Fields] AND ("decompression"[MeSH Terms] OR "decompression"[All Fields]) OR ((anterior[All Fields] AND cervical[All Fields] AND ("diskectomy"[MeSH Terms] OR "diskectomy"[All Fields] OR "discectomy"[All Fields])) OR (anterior[All Fields] AND cervical[All Fields] AND ("diskectomy"[MeSH Terms] OR "diskectomy"[All Fields]))) AND (("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang])) AND (("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang]) AND (("Nucl Eng Des/Fusion"[Journal] OR "fusion"[All Fields]) OR ("arthrodesis"[MeSH Terms] OR "arthrodesis"[All Fields]))) AND ("instrumentation "[Subheading] OR "Bone Plates"[Mesh] OR ("bone plates"[MeSH Terms] OR ("bone"[All Fields] AND "plates"[All Fields]) OR "bone plates"[All Fields] OR "plate"[All Fields]) OR plates[All Fields] OR plating[All Fields] OR instrumentation[title] OR ("computers"[MeSH Terms] OR "computers"[All Fields] OR "hardware"[All Fields]))

4. Does anterior surgery result in better outcomes (clinical or radiographic) than posterior surgery in the treatment of cervical radiculopathy from degenerative disorders?

5. Does posterior decompression with fusion result in better outcomes (clinical or radiographic) than posterior decompression alone in the treatment of cervical radiculopathy from degenerative disorders?

6. Does anterior cervical decompression and reconstruction with total disc replacement result in better outcomes (clinical or radiographic) than anterior cervical decompression and fusion in the treatment of cervical radiculopathy from degenerative disorders?

((("Radiculopathy"[All Fields] AND cervical[All Fields]) OR "cervical radiculopathy"[All Fields] OR "cervical radiculitis"[All Fields]) AND ("Intervertebral Disk Displacement"[Mesh] OR foraminal stenosis[All Fields] OR ("intervertebral disk degeneration"[MeSH Terms] OR ("intervertebral"[All Fields] AND "disk"[All Fields] AND "degeneration"[All Fields]) OR "intervertebral disk degeneration"[All Fields] OR ("disc"[All Fields] AND "degeneration"[All Fields]) OR "disc degeneration"[All Fields]) OR disk degeneration[All Fields] OR disk herniation[All Fields] OR disc herniation[All Fields] OR degenerative[All Fields]) AND (("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang])) AND (("Arthroplasty"[Mesh] AND disc[All Fields]) OR disc arthroplasty[All Fields] OR disk arthroplasty[All Fields] OR disc replacement[All Fields] OR disk replacement[All Fields] AND (("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang])) AND (("Nucl Eng Des/Fusion"[Journal] OR "fusion"[All Fields]) OR ("arthrodesis"[MeSH Terms] OR "arthrodesis"[All Fields])) AND (("Decom- pression, Surgical"[Mesh] AND anterior[All Fields] AND cervical[All Fields]) OR (anterior[All Fields] AND cervical[All Fields] AND ("decompression"[MeSH Terms] OR "decompression"[All Fields]) OR (anterior[All Fields] AND cervical[All Fields] AND ("diskectomy"[MeSH Terms] OR "diskectomy"[All Fields] OR "discectomy"[All Fields]))) AND (("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang]))

7. What is the long-term result (four+ years) of surgical management of cervical radiculopathy from degenerative disorders?

("Longitudinal Studies"[Mesh:noexp] OR (long[All Fields] AND term[All Fields]) OR long-term[All Fields] AND (("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang])) AND (((("Radiculopathy"[All Fields] AND cervical[All Fields]) OR "cervical radiculopathy"[All Fields] OR "cervical radiculitis"[All Fields]) AND ("Intervertebral Disk Displacement"[Mesh] OR foraminal stenosis[All Fields] OR ("intervertebral disk degeneration"[MeSH Terms] OR ("intervertebral"[All Fields] AND "disk"[All Fields] AND "degeneration"[All Fields]) OR "intervertebral disk degeneration"[All Fields]

OR ("disc"[All Fields] AND "degeneration"[All Fields]) OR "disc degeneration"[All Fields]) OR disk degeneration[All Fields] OR disk herniation[All Fields] OR disc herniation[All Fields] OR degenerative[All Fields]) AND (("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang])) AND ("Surgical Procedures, Operative"[Mesh] OR "surgery "[Subheading] OR surgery[title] OR surgical[title] OR operative[title] OR operation[title] AND (("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang])) AND (("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang])) AND (("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang])

8. How do long-term results of single-level compare with multilevel surgical decompression for cervical radiculopathy from degenerative disorders?

(((("Radiculopathy"[All Fields] AND cervical[All Fields]) OR "cervical radiculopathy"[All Fields] OR "cervical radiculitis"[All Fields]) AND ("Intervertebral Disk Displacement"[Mesh] OR foraminal stenosis[All Fields] OR ("intervertebral disk degeneration"[MeSH Terms] OR ("intervertebral"[All Fields] AND "disk"[All Fields] AND "degeneration"[All Fields]) OR "intervertebral disk degeneration"[All Fields] OR ("disc"[All Fields] AND "degeneration"[All Fields]) OR "disc degeneration"[All Fields]) OR disk degeneration[All Fields] OR disk herniation[All Fields] OR disc herniation[All Fields] OR degenerative[All Fields]) AND (("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang])) AND ("Decompression, Surgical"[Mesh] OR "Laminectomy"[Mesh] OR "cervical decompression"[All Fields] OR "laminectomy"[All Fields] OR "laminotomy"[All Fields] OR foraminotomy[All Fields] OR laminoplasty[All Fields] OR (cervical[All Fields] AND ("diskectomy"[MeSH Terms] OR "diskectomy"[All Fields] OR "discectomy"[All Fields])) OR (cervical[All Fields] AND ("diskectomy"[MeSH Terms] OR "diskectomy"[All Fields])))) AND ("Longitudinal Studies"[Mesh:noexp] OR (long[All Fields] AND term[All Fields]) OR long-term[All Fields] AND (("1966"[PDAT] : "3000"[PDAT]) AND "humans"[MeSH Terms] AND English[lang]))

Databases Searched:  MEDLINE (PubMed)  EMBASE  Web of Science  Cochrane Database of Systematic reviews  Cochrane Central Register of Controlled Trials

Evidentiary Table ● Cervical Radiculopathy from Degenerative Disorders, Diagnosis/Imaging

What history and physical examination findings best support a diagnosis of cervical radiculopathy from degenerative disorders?

Article Level (Alpha by of evidence Description of study Conclusion Author) Bertilson BC, Level II Prospective Retrospective Critique of methodology: Grunnesjo M, Patients not enrolled at same Strender LE. Type of Study design: case series point in their disease Reliability of evidence: <80% follow-up clinical tests in diagnostic Stated objective of study: To analyze the reliability No Validated outcome the assessment of clinical tests in the assessment of neck and arm measures used: of patients with pain in primary care patients. Tests not uniformly applied neck/shoulder across patients problems-impact Number of patients: 100 patients Small sample size of history. Spine Lacked subgroup analysis (Phila Pa 1976). Physical examination/diagnostic test description: Other: only two reviewers Oct 1 66 clinical tests divided into nine categories 2003;28(19):222 Work group conclusions: 2-2231. Results/subgroup analysis (relevant to question): Potential level: I Reliability of clinical tests was poor to fair. Only a Downgraded level: II bimanual sensitivity test reached good values. With known clinical history, the prevalence of Conclusions relative to question: positive findings increased in all test categories. This paper provides evidence Sensitivity tests remained diagnostically useful. that:history and physical findings Usually helpful tests were not as diagnostically are not definitive, and may be predictable, but also had increased positive susceptable to bias with a findings when history was prerecorded before an suggestive clinical history. exam was performed, as opposed to exam first before history was obtained. Shoulder abduction test k w/o - with history .77 - .62, Spurling's .28-.46, traction relieves.63-.8,

Author conclusions (relative to question): Sensitivity tests were the most reliable and were exempt from bias. History had no impact on reliability, however, it had an impact on the incidence of positive findings.

Chang H, Park Level IV Prospective Retrospective Critique of methodology: JB, Hwang JY, Patients not enrolled at same Song KJ. Clinical Type of Study design: case series point in their disease analysis of evidence: <80% follow-up cervical prognostic Stated objective of study: To investigate the No Validated outcome radiculopathy characteristics of cervical radiculopathy causing measures used:

causing deltoid deltoid paralysis, and to report on the surgical Tests not uniformly applied paralysis. Eur outcomes of anterior cervical decompression with across patients Spine J. Oct fusion (ACDF) for the treatment of deltoid Small sample size 2003;12(5):517- paralysis. Lacked subgroup analysis 521. Other: Number of patients: 14 Work group conclusions: Physical examination/diagnostic test description: Potential level: IV All patients had radiating pain to scapula, shoulder Downgraded level: IV or arm, with weakness of shoulder abduction due to paralysis of deltoid (graded 0-5). Severity of Conclusions relative to question: radiculopathy graded on VAS 0-10. Plain This paper provides evidence radiographs and MRI were correlated with clinical that:A painful cervical findings. Surgery performed on patients with single radiculopathy with deltoid level cervical disc herniation (CDH) or cervical paralysis arose from compressive spondylotic radiculopathy (CSR). Patients with disease at the C4-5, C5-6 and multilevel disease were excluded. C3-4 levels: 50%, 43% and 7% of the time respectively. Results/subgroup analysis (relevant to question): Paralysis of the deltoid with ipsilateral scapular, shoulder or arm pain may be the result of a single level CDH or CSR. Following are the single levels implicated and their respective frequencies: 1-C3-4 CDH (central), 4-C4-5 CDH, 1-C5-6 CDH, 3-C4-5 CSR, 5-C5-6 CSR. Both radiculopathy and deltoid paralysis improved significantly with surgery.

Author conclusions (relative to question): A painful cervical radiculopathy with deltoid paralysis emanates from the C4-5, C5-6 and C3-4 levels: 50%, 43% and 7% of the time respectively.

Davidson RI, Level III Prospective Retrospective Critique of methodology: Dunn EJ, Patients not enrolled at same Metzmaker JN. Type of Study design: case series point in their disease The shoulder evidence: <80% follow-up abduction test in diagnostic Stated objective of study: To report observations No Validated outcome the diagnosis of on a series of patients with cervical measures used: radicular pain in monoradiculopathy due to compressive disease in Tests not uniformly applied cervical whom clinical signs included relief of pain with across patients extradural abduction of the shoulder. Small sample size compressive Lacked subgroup analysis monoradiculopat Number of patients: 22 Other: hies. Spine (Phila Pa 1976). Physical examination/diagnostic test description: Work group conclusions: Sep-Oct Twenty-two patients with arm pain had cervical Potential level: III 1981;6(5):441- extradural myelographic defects. 15/22 patients Downgraded level: III 446. had relief from their pain with shoulder abduction (SAR). The 15 patients in the SAR group all had Conclusions relative to question: extradural defects consistent with their clinical This paper provides evidence findings. Motor weakness was present in 15, that:relief from arm pain with

paresthesias in 11 and reflex changes in 9 shoulder abduction is an indicator patients. of cervical extradural compressive radiculopathy. Results/subgroup analysis (relevant to question): Of the 15 patients with a positive shoulder abduction sign, 13 required surgery and all achieved good results. Two of the 15 had pain relief with conservative therapy. Of the seven patients with negative shoulder abduction signs, five required surgery and two were successfully treated with traction. Of the five surgical patients, three had surgery for a central lesion and improved after surgery, two had surgery for a lateral disc fragment and only one had good results.

Author conclusions (relative to question): The shoulder abduction test is a reliable indicator of significant cervical extradural compressive radicular disease.

Henderson CM, Level II Prospective Retrospective Critique of methodology: Hennessy RG, Patients not enrolled at same Shuey HM, Jr., Type of Study design: observational point in their disease Shackelford EG. evidence: <80% follow-up Posterior-lateral prognostic Stated objective of study: Report the results of No Validated outcome foraminotomy as posterior foraminotomy in the treatment of cervical measures used: an exclusive radiculopathy. Tests not uniformly applied operative across patients technique for Number of patients: 736 patients underwent one or Small sample size cervical more posterior-lateral foraminotomies for simple Lacked subgroup analysis radiculopathy: a cervical radiculopathy. Other: review of 846 consecutively Physical examination/diagnostic test description: Work group conclusions: operated cases. The following symptoms were present: arm pain Potential level: II Neurosurgery. 99.4%, neck pain 79.7%, scapular pain 52.5%, Downgraded level: II Nov anterior chest pain 17.8%, and headache 9.7%. 1983;13(5):504- Eleven patients presented with only left chest and Conclusions relative to question: 512. arm pain ("cervical angina"). 53.9% of patients had This paper provides evidence pain or paresthesia in a dermatomal pattern. In that: 71.5% of the time, the 45.5%, the pain or paresthesia was diffuse or operative site can be accurately nondermatomal. No pain or parasthesia was predicted on the basis of clinical reported by 0.6% of patients. 85.2% of patients findings. reported a sensory change to pinprick, 68% had a specific motor deficit, and 71.2% had a specific decrease in a deep tendon reflex (DTR).

Results/subgroup analysis (relevant to question): One level was thought to be primary 87.3% of the time and two levels were felt to be equally involved 12.7% of the time. The correlation between pain/paresthesia, motor deficit, DTR change, and

the primary operative space was 73.8%, 84.8% and 83.5%, respectively. There was a 71.5% incidence of correlation between preoperative clinical findings and operative findings. Good or excellent results were reported by 91.5% of patients. Good or excellent relief of arm pain was found in 95.5% of patients, neck pain in 88.8%, scapular pain in 95.9%, chest pain in 95.4% and headache in 89.8%. Resolution of DTRs were reported by 96.9%. Residual sensory deficit was found in 20.9% of patients, and motor deficit in 2.3%.

Author conclusions (relative to question): In a large group of patients with cervical radiculopathy, the study elucidates the common clinical findings of pain, paresthesia, motor deficit, and decreased deep tendon reflexes, along with their respective frequencies. It presents evidence that the operative site can be accurately predicted on the basis of clinical findings 71.5% of the time.

Jenis LG, An Level IV Prospective Retrospective Critique of methodology: HS. Neck pain Patients not enrolled at same secondary to Type of Study design: case series point in their disease radiculopathy of evidence: <80% follow-up the fourth prognostic Stated objective of study: To report the results of No Validated outcome cervical root: an surgical intervention in a series of patients with measures used: analysis of 12 neck pain from C4 radiculopathy. Tests not uniformly applied surgically treated across patients patients. J Number of patients: 12 (11 with cervical Small sample size Spinal Disord. radiculopathy without myelopathy) Lacked subgroup analysis Aug Other: 2000;13(4):345- Physical examination/diagnostic test description: 349. Pain localized to the posterior aspect of the neck, Work group conclusions: lateralized to the side with more involvement of the Potential level: IV C4 root. Pain also reported in trapezial areas and Downgraded level: IV upper extremities depending on the presence of more caudal radiculopathies. Neck pain was Conclusions relative to question: exacerbated by flexion and extension in all This paper provides evidence patients. Decreased sensation in the C4 that:Neck pain with or without dermatome was uniformily present. MRI in all upper extremity clinical findings patients and CT scan in three patients were should include evaluation for a C4 performed prior to surgery. Excluding the radiculopathy. The examination myelopathic patient, four patients were treated with should include C4 sensory ACDF and seven patients were treated with PLF testing. including 3/7 PSF. Evaluation of surgical results was determined by status of fusion, pain relief and level of activity based on Odom's criteria. Follow-up data was obtain at 12-48 months.

Results/subgroup analysis (relevant to question): Excluding the myelopathic patient, excellent, good and satisfactory relief was obtained in five, five and one patient, respectively. The three patients with isolated C4 radiculopathy had excellent results.

Author conclusions (relative to question): Neck pain with or without upper extremity clinical findings should include evaluation for a C4 radiculopathy. The examination should include C4 sensory testing.

Makin GJ, Level IV Prospective Retrospective Critique of methodology: Brown WF, Patients not enrolled at same Ebers GC. C7 Type of Study design: case series point in their disease radiculopathy: evidence: <80% follow-up importance of prognostic Stated objective of study: Report on six cases with No Validated outcome scapular winging scapular winging as a finding in some patients with measures used: in clinical C7 radiculopathy Tests not uniformly applied diagnosis. J across patients Neurol Number of patients: 6 Small sample size Neurosurg Lacked subgroup analysis Psychiatry. Jun Physical examination/diagnostic test description: Other: 1986;49(6):640- Scapular winging was detected with the hands at 644. shoulder level. In the remainder scapular winging Work group conclusions: was only evident when pushing against the wall Potential level: IV with the hands at waist level. This latter method Downgraded level: IV places the serratus anterior muscle at a mechanical disadvantage and reveals partial Conclusions relative to question: paralysis. This paper provides evidence that: scapular winging may be a Results/subgroup analysis (relevant to question): feature of C7 radiculopathy in Each case confirmed by surgery or by CTM some patients and should not be misleading when present. Author conclusions (relative to question): Scapular winging may be a component of C7 radiculopathy and when present serves to exclude lesions of the brachial plexus or radial nerve.

Ozgur BM, Level IV Prospective Retrospective Critique of methodology: Marshall LF. Patients not enrolled at same Atypical Study design: case series point in their disease presentation of Type of <80% follow-up C-7 evidence: Stated objective of study: review 241 consecutive No Validated outcome radiculopathy. J prognostic C6-7 discectomy patients for "presenting measures used: Neurosurg. Sep symptomatology" Tests not uniformly applied 2003;99(2 across patients Suppl):169-171. Number of patients: 241 Small sample size Lacked subgroup analysis Physical examination/diagnostic test description: Other: clinical evaluation of presenting signs and

symptoms for usual and unusual findings Work group conclusions: Potential level: IV Results/subgroup analysis (relevant to question): Downgraded level: IV Most patients had usual C7 traditional radicular signs (dermatomal distribution), with 12% reporting Conclusions relative to question: sole complaint of subscapular pain, 5% having This paper provides evidence deep breast or chest pain. None of these 17% had that:a significant percentage of the "typical" C7 presenting symptoms. patients may present with atypical symptoms, in addition to or Author conclusions (relative to question): Patients without standard symptoms (eg, presenting with unusual symptoms had their scapular pain only). These complaints validated by surgical findings and 93% patients responded well to experienced symptom relief surgical treatment.

Persson LCG, Level III Prospective Retrospective Critique of methodology: Carlsson JY, Patients not enrolled at same Anderberg L. Type of Study design: observational point in their disease Headache in evidence: <80% follow-up patients with prognostic Stated objective of study: To describe the No Validated outcome cervical frequency of headaches in patients with lower level measures used: radiculopathy: A cervical radiculopathy and its response to a Tests not uniformly applied prospective selective nerve root block (SNRB). across patients study with Small sample size selective nerve Number of patients: Of 275 total patients, 161 Lacked subgroup analysis root blocks in complained of headaches in addition to other Other: 50% threshold and lack 275 patients. symptoms. These are the ones studied. of specificity of the injection European Spine Journal. Jul Physical examination/diagnostic test description: Work group conclusions: 2007;16(7):953- Of 275 patients, 161 suffered from daily or Potential level: II 959. recurrent headaches, most often ipsilateral to the Downgraded level: III patients' radiculopathy. All patients underwent clinical exam and MRI. Patients with significantly Conclusions relative to question: compressed nerve root underwent SNRB. Effect This paper provides evidence on headache was evaluated with VAS. that:Complaint of headache is also a common symptom with C4 Results/subgroup analysis (relevant to question): and lower nerve compression All patients with headaches had tender points in problems. SNRB can reduce the neck/shoulder region ipsilateral to the headaches in a significant radiculopathy. Patients with headache had percentage of patients, and this significantly more limitations in daily activites and was considered significant as a higher pain in the neck/shoulder. Immediately diagnostic tool. before the injections, 161 (59%) of patients experienced a headache exceeding 15 on the VAS. Of the 161 patients, 101 (63%) experienced >25% headache reduction following SNRB, 93 (58%) reported greater than 50% headache reduction, 66 experienced 100% relief. (C4 3%, C5 11%, C6 52%, C7 29%, C8 5%) A significant correlation was found between reduced headache and decreased pain in the neck and shoulder region.

Author conclusions (relative to question): Cervical nerve root compression from degenerative disease in the lower cervical spine producing radiculopathy can also result in headache. The neck pain seems to restrict the patient's activity. Headache classification and assessment together with muscle palpation should be part of the neck exam for patients with cervical radiculopathy.

Post NH, Cooper Level IV Prospective Retrospective Critique of methodology: PR, Frempong- Patients not enrolled at same Boadu AK, Type of Study design: case series point in their disease Costa ME. evidence: <80% follow-up Unique features prognostic Stated objective of study: Review their experience No Validated outcome of herniated with the operative management of a series of measures used: discs at the patients with C7-T1 herniations. Tests not uniformly applied cervicothoracic across patients junction: Clinical Number of patients: 10 Small sample size presentation, Lacked subgroup analysis imaging, Physical examination/diagnostic test description: Other: operative Symptoms included shoulder pain radiating into the management, lateral aspect of the hand, hand weakness and Work group conclusions: and outcome weakness in finger flexion, finger extension, and Potential level: IV after anterior intrinsic hand muscles. Sensation and DTRs were Downgraded level: IV decompressive unremarkable. operation in 10 Conclusions relative to question: patients. Results/subgroup analysis (relevant to question): This paper provides evidence Neurosurgery. MRI on each patient revealed a soft disc that:C8 radiculopathy usually Mar compressing the C8 nerve. Recovery of hand presents as weakness of the 2006;58(3):497- strength was noted in each patient, however, hand, and pain radiating to 501. recovery was incomplete in two patients with shoulder, scapular area, and to symptoms greater than four months. the fourth and fifth fingers. Physical exam may reveal normal Author conclusions (relative to question): None sensory and DTR's. Motor stated examination may show weakness of flexors and extensors of the fingers and also weakness of intrinsic muscles of the hand.

Shah KC, Level II Prospective Retrospective Critique of methodology: Rajshekhar V. Patients not enrolled at same Reliability of Type of Study design: observational point in their disease diagnosis of soft evidence: <80% follow-up cervical disc diagnostic Stated objective of study: To determine the No Validated outcome prolapse using sensitivity and specificity of the Spurling's test in measures used: Spurling's test. predicting the diagnosis of a soft lateral cervical Tests not uniformly applied Br J Neurosurg. disc herniation in patients with neck and arm pain. across patients Oct Small sample size 2004;18(5):480- Number of patients: 50 Lacked subgroup analysis 483. Other:

Physical examination/diagnostic test description: Spurling's test with cervical extension, lateral Work group conclusions: flexion to the side of pain, and downward pressure Potential level: II on the head was performed on all patients. Downgraded level: II Twenty-five patients underwent surgery (Group 1) and 25 were managed conservatively (Group 2). Conclusions relative to question: Spurling's test correlated with surgical findings in This paper provides evidence Group 1, and with MRI findings in Group 2. that:a positive Spurling's test can Patients with minimal or no neurologic deficits with increase the incidence of the first episode of radicular pain and those who compressive disease in patients refused surgery were managed conservatively. undergoing evaluation for cervical radiculopathy. Results/subgroup analysis (relevant to question): Group 1 (25 patients): 18/18 with a positive Spurling's test had a soft disc herniation. Of seven patients with a negative Spurling's test, two had a soft disc herniation and five had a hard disc. Group 2 (25 patients): Of the 10 patients with a positive Spurling's test, nine had a soft disc herniation, one had a hard disc. Of the 15 patients with a negative Spurling's test, a hard disc was seen in eight, and MRI was normal in seven. The Spurling's test had a sensitivity of 92%, a specificity of 95%, a positive predictive value (PPV) of 96.4% and a negative predictive value (NPP) of 90.9% for a soft disc herniation.

Author conclusions (relative to question): The high PPV indicates that the Spurling's test can be used to increase the incidence of disease in patients undergoing MRI for cervical radiculopathy.

Slipman CW, Level I Prospective Retrospective Critique of methodology: Plastaras CT, Patients not enrolled at same Palmitier RA, Type of Study design: observational point in their disease Huston CW, evidence: <80% follow-up Sterenfeld EB. prognostic Stated objective of study: To study the distribution No Validated outcome Symptom of pain and parasthesias that result from the measures used: provocation of stimulation of specific cervical nerve roots. Tests not uniformly applied fluoroscopically across patients guided cervical Number of patients: 87 patients, 134 selective Small sample size nerve root nerve root stimulations Lacked subgroup analysis stimulation. Are Other: dynatomal maps Physical examination/diagnostic test description: identical to Mechanical stimulation of nerve roots were carried Work group conclusions: dermatomal out: 4 at C4, 14 at C5; 43 at C6; 52 at C7; and Potential level: I maps? Spine 21 at C8. An independent observer recorded the Downgraded level: I (Phila Pa 1976). location of provoked symptoms on a pain diagram. Oct 15 Visual data was compiled using a 793 body sector Conclusions relative to question: 1998;23(20):223 bit map with 43 body regions identified. This paper provides evidence 5-2242. that:distribution of pain and

Results/subgroup analysis (relevant to question): paresthesias in the arm from Although the distribution of symptom provocation nerve root stimulation can be resembled the classic dermatomal maps, different than dermatomal maps symptoms were frequently provoked outside the in a significant percentage of classic descriptions. patients, making it difficult to identify the level based on pain Author conclusions (relative to question): There distribution. In some patients it was a distinct difference between the dynatomal explains the nondermatomal and dermatomal maps. distribution of pain.

Tanaka Y, Level I Prospective Retrospective Critique of methodology: Kokubun S, Sato Patients not enrolled at same T, Ozawa H. Type of Study design: observational point in their disease Cervical roots as evidence: <80% follow-up origin of pain in prognostic Stated objective of study: To determine if pain in No Validated outcome the neck or the neck or scapular regions in patients with measures used: scapular cervical radiculopathy originates from the Tests not uniformly applied regions. Spine. compressed nerve root and whether the site of across patients Aug 1 pain is useful for identifying the level involved. Small sample size 2006;31(17):E56 Lacked subgroup analysis 8-573. Number of patients: 50 consecutive Other:

Physical examination/diagnostic test description: Work group conclusions: Patients who experienced pain with arm and finger Potential level: I symptoms underwent single level decompression. Downgraded level: I The level was determined based on correlation of symptoms and imaging, and SNRB in five patients. Conclusions relative to question: Cervical disc herniation was found in 20 patients This paper provides evidence and stenosis in 30. Patients underwent posterior that:cervical radiculopathy at C5, open foraminotomy with follow-up at one month C6, C7 and C8 frequently causes and one year after surgery. pain in suprascapular, interscapular and scapular areas Results/subgroup analysis (relevant to question): and is useful in determining the Pain preceeded the arm/finger symptoms in 35 level of nerve root involvement. patients (70%) and was relieved early in 46 (92%). Pain in the suprascapular region When the pain was suprascapular, C5 or C6 indicates C5 or C6 radiculopathy, radiculopathy was frequent. When it was the pain in the interscapular interscapular, C7 or C8 radiculopathy was region indicates C7 or C8 frequent. When scapular, C8 was frequent. Arm radiculopathy, and pain in the and finger symptoms improved significantly in all scapular region indicates C8 groups after decompression. Sixty-one painful sites radiculopathy. were noted before surgery: one in 39 patients, and two in 11 patients. Following surgery, 27 patients reported complete pain relief, 23 had pain in 24 regions and seven reported no change with surgery. Seventeen pain sites were new since surgery. All but one new site were nuchal and suprascapular. At one year follow-up, 45 patients reported no pain, five patients had pain in six sites, three of which were the same as before surgery. C5 pain localized to the nuchal, scapula, and

suprascapular areas; C6, suprascapular pain was significant; C7, interscapular pain was frequent; and C8, interscapular pain and scapular pain was frequent.

Author conclusions (relative to question): Pain in the suprascapular, interscapular or scapular regions can orginate directly in the compressed root and is valuable for determing the nerve root involved.

Tong HC, Haig Level IV Prospective Retrospective Critique of methodology: AJ, Yamakawa Patients not enrolled at same K. The Spurling Type of Study design: comparative point in their disease test and cervical evidence: <80% follow-up radiculopathy. diagnostic Stated objective of study: To determine the No Validated outcome Spine (Phila Pa sensitivity and specificity of the Spurling test for measures used: 1976). Jan 15 cervical radiculopathy. Tests not uniformly applied 2002;27(2):156- across patients 159. Number of patients: 255 patients were referred for Small sample size electrodiagnosis of upper extremity nerve Lacked subgroup analysis disorders. Other: poor reference standard. Physical examination/diagnostic test description: The Spurling test was performed on all patients Work group conclusions: before EMG. The test was scored as positive if it Potential level: IV resulted in pain or tingling starting in the shoulder Downgraded level: IV and radiating distal to the elbow. A differential diagnosis based on the history and physical exam Conclusions relative to question: was made prior to EMG. EMG was performed and This paper provides evidence each diagnosis in the differential was scored that:The Spurling's test is not relative to the likelihood of its occurrence. sensitive, but is specific for cervical radiculopathy as Results/subgroup analysis (relevant to question): diagnosed by EMG. A positive Of the 255 patients presented, 31 had missing test increases the incidence of data, leaving 224 patients for inclusion. Of 20 radiculopathy in patients patients with a positive EMG for cervical undergoing EMG for upper radiculopathy, the Spurling's test was positive in extremity nerve disorders. seven, for a sensitivity of 7/20 or 30%. Of 172 patients with no EMG evidence for radiculopathy, the Spurling's test was negative in 160, for a specificity of 160/172 or 93%. The Spurling's test was positive in 16.6% of patients with a normal EMG, in 3.4% of patients with an EMG diagnosis of a nerve problem other than radiculopathy, and in 15% of patients with nonspecific EMG findings. The odds ratio of a positive Spurling's test for a positive EMG for cervical radiculopathy is 5.71.

Author conclusions (relative to question): Spurling's test is not sensitive, but is specific for

cervical radiculopathy as diagnosed by EMG. Not useful as a screening test, but may be useful to confirm the diagnosis.

Wainner RS, Level IV Prospective Retrospective Critique of methodology: Fritz JM, Irrgang Patients not enrolled at same JJ, Boninger ML, Type of Study design: comparative point in their disease Delitto A, Allison evidence: <80% follow-up S. Reliability and diagnostic Stated objective of study: To assess the reliability No Validated outcome diagnostic and accuracy of individual clinical exam items and measures used: accuracy of the self reported instruments for the diagnosis of Tests not uniformly applied clinical cervical radiculopathy, and to identify and assess across patients examination and the accuracy of an optimal cluster of test items. Small sample size patient self- Lacked subgroup analysis report measures Number of patients: 82 Other: EMG gold standard, for cervical also test selection bias. radiculopathy. Physical examination/diagnostic test description: Spine (Phila Pa Consecutive patients referred for EMG for the Work group conclusions: 1976). Jan 1 evaluation of cervical radiculopathy (CR) or carpal Potential level: III 2003;28(1):52- tunnel syndrome (CTS). Only patients judged by Downgraded level: IV 62. the laboratory provider (seven different providers) to have signs and symptoms compatible with CR or Conclusions relative to question: CTS were eligible to participate. Patients with This paper provides evidence Class 5 or 6 cervical radiculopathy findings were that:Provocative tests, including further classified according to the severity of their the Spurling's test, shoulder EMG findings. Self-reported items included the abduction test, Valsalva and VAS and NDI. Standardized clinical exam was distraction test had a low performed by two of nine physical therapists and sensitivity and high specificity for contained 34 items. History contained six questions cervical radiculopathy as asked by two physical therapists. Neurological diagnosed by EMG. exam included strength, DTRs and sensation. Provocative tests included Spurling's test, shoulder abduction test, Valsalva maneuver, neck distraction test and the upper limb tension test. Cervical range of motion measured.

Results/subgroup analysis (relevant to question): Fifteen patients had an EMG diagnosis of cervical radiculopathy (CR), five patients with CR and concomitant ulnar neuropathy and CTS. One patient with combined findings dropped out of the study. Of the 19 patients reported, 13 had mild symptoms and six had moderate symptoms. Reliability of different clinical items were reported including the Spurlings A/B .6/.62, shoulder abduction .2, valsalva .69, distraction .88, Upper Limb Tension Test (ULTT) A/B .76/.83. Sensitivity/specificity: Spurlings A/B .6/.62, shoulder abduction .2, valsalva .69, distraction .88, ULTT A/B .76/.83. 19 patients with CR (13 mild, 6 moderate).

Sensitivity/Specificity: Spurling's A/B - 0.5/0.86 - 0.74; shoulder abduction - 0.17/0.92; valsalva - .22/.94; distraction - 0.44/0.9; ULTT A/B - 0.72- 0.97/0.22-0.33. Cluster of ULTTA, cervical rotation <60degrees, distraction, and Spurling's A - 0.24/0.99

Author conclusions (relative to question): Many items were found to have at least a fair level of reliability, and to have acceptable diagnostic properties. The test item cluster identified was found to be the most useful.

Yoss RE, Corbin Level II Prospective Retrospective Critique of methodology: KB, Maccarty Patients not enrolled at same CS, Love JG. Type of Study design: observational point in their disease Significance of evidence: <80% follow-up symptoms and prognostic Stated objective of study: To correlate clinical No Validated outcome signs in findings with operative findings when a single measures used: localization of cervical nerve root (C5,C6,C7,C8) is compressed Tests not uniformly applied involved root in by a CDH. across patients cervical disk Small sample size protrusion. Number of patients: 100 Lacked subgroup analysis Neurology. Oct Other: Marked testing bias 1957;7(10):673- Physical examination/diagnostic test description: 683. Symptoms included pain in the neck, shoulder, Work group conclusions: scapular or interscapular region, arm, forearm or Potential level: II hand; paresthesias in forearm, and hand; and Downgraded level: II weakness of upper extremity. Signs included diminution of triceps, biceps and brachioradialis Conclusions relative to question: reflexes, muscle weakness and sensory loss. This paper provides evidence Surgically verified nerve root compression, that:Clinical findings related to the sufficient information to support the surgeons fingers are the most accurate for preoperative impression, relief of symptoms localizing a CDH to a single level. following surgery. Single level CDH may produce signs and symptoms that Results/subgroup analysis (relevant to question): correspond to overlapping The presence of pain or paresthesia in the neck, dermatomal levels. shoulder, scapular or interscapular region was present in cases of C5, C6, C7, C8 compression. The presence of pain in the arm corresponded to the site compression in 23% of cases. The presence of pain or paresthesia in the forearm corresponded to a single root or one of two roots in 32% and 66%, respectively. Hand pain and paresthesia corresponded to a single root or one of two roots in 70% and 27%, respectively. Subjective weakness corresponded to a single level in 22/34 (79%) cases. When a diminution of DTR was present, the lesion could be correctly localized to a single level or one

of two levels in 11% and 82%, respectively. Objective muscle weakness corresponded to a single root or one of two roots in 77% and 12%, respectively. All cases of objective weakness in which root C5 or C8 was involved, the level was correctly localized. Sensory loss corresponded to a single root or one of two roots in 65% and 35%, respectively.

Author conclusions (relative to question): Clinical findings related to the fingers are the most accurate for localizing a CDH to a single level. A single level CDH may produce signs and symptoms that correspond to overlapping dermatomal levels.

Evidentiary Table ● Cervical Radiculopathy from Degenerative Disorders, Diagnosis/Imaging

What are the most appropriate diagnostic tests (including imaging and electrodiagnostics), and when are these tests indicated in the evaluation and treatment of cervical radiculopathy from degenerative disorders?

Article Level (Alpha by of Description of study Conclusion Author) evidence

Alrawi MF, Level III Prospective Retrospective Critique of methodology: Khalil NM, Nonconsecutive patients Mitchell P, Type of Study design: case series Small sample size Hughes SP. evidence: No consistently applied gold The value of diagnostic Stated objective of study: Investigate standard neurophysiologi whether preoperative electromyography Poor reference standard/no gold cal and imaging (EMG) can help select those most likely to standard applied studies in benefit from intervention. Lacked subgroup analysis predicting Other: outcome in the Diagnostic test(s) studied: surgical Clinical exam/history Work group conclusions: treatment of Electromyography Potential level: III cervical Myelogram Downgraded level: III radiculopathy. MRI Eur Spine J. CT Conclusions relative to question: Apr CT/Myelogram This paper provides evidence 2007;16(4):495- Other: that:Patients with cervical 500. radiculopathy and an MRI showing a Compared to: disc bulge with narrowing of the exit Clinical exam/history foramina have better clinical Electromyography outcomes and patient satisfaction Myelogram from their anterior cervical MRI decompression with fusion (ACDF) if CT a preoperative EMG shows CT/Myelogram denervation changes. Other:

Gold standard? Yes No If “Yes,” please specify: surgical outcome

Number of patients: 20

Consecutively assigned? No

Results/subgroup analysis (relevant to question): Study of 20 patients with clinical manifestations of cervical

radiculopathy and an magnetic resonance imaging (MRI) showing disc bulges associated with narrowing of the exit foramina. The operative level was unclear in all patients. Preoperatively patients were divided into groups A and B on the basis of an EMG. Group A had eight patients with denervation changes in the distribution of a least one cervical nerve root. Group B had 12 patients with no EMG evidence of cervical radiculopathy. Patients in group A had better clinical outcomes and patient satisfaction from their ACDF at least 12 months postoperatively than patients in group B.

Author conclusions (relative to question): Preoperative neurophysiological studies (NPS) can help identify which patients are likely to benefit from surgery for cervical radiculopathy.

Anderberg L, Level III Prospective Retrospective Critique of methodology: Annertz M, Nonconsecutive patients Rydholm U, Type of Study design: case series Small sample size Brandt L, evidence: No consistently applied gold Saveland H. diagnostic Stated objective of study: Assess the standard Selective ability of transforaminal selective nerve Poor reference standard/no gold diagnostic root blocks (SNRB) to correlate clinical standard applied nerve root block symptoms with MRI findings in patients Lacked subgroup analysis for the with cervical radiculopathy and two level Other: surgical treatment or evaluation of MRI degeneration ipsilateral to the transforminal epidural steroid injection radicular pain in radicular pain. (ESI) treatment performed in only the multilevel 22/30 degenerated Diagnostic test(s) studied: cervical spine. Clinical exam/history Eur Spine J. Electromyography Work group conclusions: Jun Myelogram Potential level: III 2006;15(6):794- MRI Downgraded level: III 801. CT CT/Myelogram Conclusions relative to question: Other: SNRB This paper provides evidence that:SNRB may be useful in the Compared to: preoperative evaluation of patients Clinical exam/history with radiculopathy and findings of Electromyography compressive lesion at multiple levels Myelogram on MRI. MRI CT CT/Myelogram

Other:

Gold standard? Yes No If “Yes,” please specify: surgical outcomes

Number of patients: 30

Consecutively assigned? Yes

Results/subgroup analysis (relevant to question): Of 30 patients, 22 had neurologic deficits that occurred with cervical radiculopathy. Degenerative changes on MRI were found in close relation to nerve roots. Neuroforaminal narrowing was graded as slight, moderate or severe, without further analysis. Clinical findings were correlated with MRI findings and root block levels were determined. No analgesics were administered within 12 hours prior to the procedure, and there was no mention if sedation was given prior to the procedure. An unspecified volume of contrast was administered to confirm perineural needle position within the foramen prior to SNRB. SNRB with 0.5 ml solution of 5 mg of Mepivacaine was administered. VAS outcomes were assessed 30 minutes and four hours after SNRB. VAS reduction of at least 50% was required to determine that the SNRB was positive; no indication if VAS score occurred 30 minutes or 4 hours after the SNRB. In 18 patients with positive SNRB at a single level, the SNRB correlated with the level of more marked pathology in 12, to the level determined by the neurologic deficits in eight, and to the level corresponding to the sensory dermatone in seven. In 11 patients with positive SNRB at two levels, these levels corresponded to findings on MRI in 6. Of 13 patients treated at one level, 9 (67%) had good or excellent results. Of nine patients treated at two levels, 100% had good or excellent results.

Author conclusions (relative to question): Clinical symptoms and signs in isolation or in combination with MRI findings are

not always reliable indicators of the pain generating nerve root. SNRB may be useful in treatment planning in patients with radiculopathy and degenerative changes at two levels ipsilateral to the patient's symptoms

Anderberg L, Level II Prospective Retrospective Critique of methodology: Saveland H, Nonconsecutive patients Annertz M. Type of Study design: case series Small sample size Distribution evidence: No consistently applied gold patterns of diagnostic Stated objective of study: Study the standard transforaminal selectivity of cervical transforaminal Poor reference standard/no gold injections in the injections and the distributions of a range standard applied cervical spine of injection volumes in patients with Lacked subgroup analysis evaluated by cervical radiculopathy. Other: multi-slice computed Diagnostic test(s) studied: Work group conclusions: tomography. Clinical exam/history Potential level: II European Electromyography Downgraded level: II Spine Journal. Myelogram Oct MRI Conclusions relative to question: 2006;15(10):14 CT This paper provides evidence 65-1471. CT/Myelogram that:transforaminal injectate volumes Other: SNRB of 0.6 ml consistently meet the criteria for SNRB. Compared to: Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other:

Gold standard? Yes No If “Yes,” please specify: CT

Number of patients: 9

Consecutively assigned? Yes

Results/subgroup analysis (relevant to question): Three groups of three patients received either 0.6, 1.1 and 1.7 ml of injectate via the transforaminal root technique used by Kikuchi. The groups injected with 0.6 and 1.1 ml received local anesthetic and contrast. The group injected with 1.7 ml received local anesthetic, corticosteroid and contrast.

Contrast distribution was determined by a postinjection CT scan. An injection was considered a SNRB if the contrast media surrounded an adjacent nerve root by less than half of its circumference. In all three patients receiving 0.6 ml of injectate, the injections were considered SNRB. In 1/3 of patients the contrast was noted in an intraspinal/epidural distribution. In 2/3 of patients given 1.1 ml of injectate the injections were considered SNRB. In both of these SNRB injections, there was spread of contrast around less than one- half the circumference of adjacent nerve roots. None of the three patients receiving 1.7 ml of injectate had a SNRB. The perineural distribution length averaged 36 mm, with no correlation to injectate volume.

Author conclusions (relative to question): Only 0.6 ml injections should be accepted as SNRB.

Ashkan K, Level III Prospective Retrospective Critique of methodology: Johnston P, Nonconsecutive patients Moore AJ. A Type of Study design: comparative Small sample size comparison of evidence: No consistently applied gold magnetic diagnostic Stated objective of study: To assess standard resonance whether neurophysiologic studies (NPS) Poor reference standard/no gold imaging and added significant information to high standard applied neurophysiologi resolution MRI in the evaluation of Lacked subgroup analysis cal studies in cervical radiculopathy. Other: the assessment of cervical Diagnostic test(s) studied: Work group conclusions: radiculopathy. Clinical exam/history Potential level: III Br J Neurosurg. Electromyography Downgraded level: III Apr Myelogram 2002;16(2):146- MRI Conclusions relative to question: 148. CT This paper provides evidence CT/Myelogram that:MRI is mlore accurate and more Other: nerve conduction studies sensitive than NPS in the preoperative evaluation of patients Compared to: with cervical radiculopathy. Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other:

Gold standard? Yes No If “Yes,” please specify: surgical outcomes

Number of patients: 45

Consecutively assigned? No

Results/subgroup analysis (relevant to question): Of the 45 patients, three experienced bilateral symptoms. Radicular arm pain was present in all cases, parasthesias in 28, numbness in 22 and subjective weakness in 14. Following surgery, 36 patients had complete resolution of symptoms and seven experienced significant improvement in symptoms. Of patients who improved following surgery, 16 (37%) had a positive MRI and NPS; 24 (56%) had a positive MRI and negative NPS; two (5%) had a negative MRI and positive NPS; and one (2%) had negative MRI and NPS studies. In the three cases with a negative MRI, surgical plans were based on the NPS in one case and on CTM in two. In five patients with foraminal stenosis on MRI the patients did not improve. Of these five patients, four were operated on at the level indicated by MRI. Sensitivity for diagnosing cervical radiculopathy was 93% for MRI and 42% for NPS; with positive predictive values at 91% for MRI and 86% for NPS. Negative predictive values were 25% for MRI, and 7% for NPS.

Author conclusions (relative to question): In patients with clinical and MRI evidence of cervical radiculopathy, NPS has limited additional diagnostic value.

Bartlett RJV, Level II Prospective Retrospective Critique of methodology: Hill CR, Nonconsecutive patients Gardiner E. A Type of Study design: comparative Small sample size comparison of evidence: No consistently applied gold T₂ diagnostic Stated objective of study: To compare the standard and gadolinium accuracy of gadolinium (Gd) enhanced Poor reference standard/no gold enhanced MRI MRI with 3D gradient recalled echo (3D standard applied with CT GRE) images in the evaluation of cervical Lacked subgroup analysis

myelography in radiculopathy. Other: cervical radiculopathy. Diagnostic test(s) studied: Work group conclusions: British Journal Clinical exam/history Potential level: II of Radiology. Electromyography Downgraded level: II Jan Myelogram 1998;71(JAN.): MRI Conclusions relative to question: 11-19. CT This paper provides evidence CT/Myelogram that:MRI with 3D T2 technique has an Other: accuracy approaching that of CT myelography for the diagnosis of a Compared to: compressive lesion in patients with Clinical exam/history cervical radiculopathy. Electromyography Myelogram MRI CT CT/Myelogram Other:

Gold standard? Yes No If “Yes,” please specify: best diagnosis reviewing all the studies

Number of patients: 20

Consecutively assigned? Yes

Results/subgroup analysis (relevant to question): 3D GRE images had an accuracy of 87% for the diagnosis of foraminal encroachment. CTM had an accuracy of 90%. MRI with Gd conferred no additional benefit. Oblique reconstructions were less accurate than axial images.

Author conclusions (relative to question): MRI with 3D GRE images is an acceptable technique for the primary evaluation of cervical radiculopathy. CTM remains indicated for patients with incongruent symptoms and MRI results.

Hedberg MC, Level III Prospective Retrospective Critique of methodology: Drayer BP, Nonconsecutive patients Flom RA, Type of Study design: comparative Small sample size Hodak JA, Bird evidence: No consistently applied gold CR. Gradient diagnostic Stated objective of study: To determine standard echo (GRASS) the accuracy of MRI with limited flip angle Poor reference standard/no gold MR imaging in (LFA) GRE technique in patients with standard applied

cervical cervical radiculopathy. Lacked subgroup analysis radiculopathy. Other: older technique AJR Am J Diagnostic test(s) studied: Roentgenol. Clinical exam/history Work group conclusions: Mar Electromyography Potential level: III 1988;150(3):68 Myelogram Downgraded level: III 3-689. MRI CT Conclusions relative to question: CT/Myelogram This paper provides evidence Other: that:MRI is accurate in the diagnosis of disc herniation and degenerative Compared to: abnormalities in the spine. Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other:

Gold standard? Yes No If “Yes,” please specify: surgical findings

Number of patients: 13/130

Consecutively assigned? Yes

Results/subgroup analysis (relevant to question): MRI was performed in 130 patients, myelography in 30, CTM in 16 and CT in five. Pathologic confirmation was obtained in 13 surgically treated patients. Of the studies, 31 were normal and neither myelography nor surgery were performed. Extradural defects were detected in 99/130 patients (52 central, 26 dorsolateral osteophyte, 4 dorsolateral disc, 17 dorsolateral disc/osteophyte). Myelography/CTM and nonenhanced CT confirmed the abnormalities in 20 and five patients, respectively. Surgical findings from 13 patients and 30 sites showed correlation with MRI on 3/3 herniations and 26/27 degenerative abnormalities.

Author conclusions (relative to question): MRI is sufficient for the evaluation of cervical radiculopathy and may obviate the need for more invasive myelography and CT.

Houser OW, Level III Prospective Retrospective Critique of methodology: Onofrio BM, Nonconsecutive patients Miller GM, Type of Study design: case series Small sample size Folger WN, evidence: No consistently applied gold Smith PL. diagnostic Stated objective of study: To correlate the standard Cervical Disk findings on CTM with surgical and path Poor reference standard/no gold Prolapse. Mayo proven cervical herniations. standard applied Clinic Lacked subgroup analysis Proceedings. Diagnostic test(s) studied: Other: Oct Clinical exam/history 1995;70(10):93 Electromyography Work group conclusions: 9-945. Myelogram Potential level: III MRI Downgraded level: III CT CT/Myelogram Conclusions relative to question: Other: This paper provides evidence that:CT myelography can identify 90% of Compared to: cervical extruded disc herniations Clinical exam/history confirmed by surgery. Electromyography Myelogram MRI CT CT/Myelogram Other:

Gold standard? Yes No If “Yes,” please specify: surgical findings/pathology

Number of patients: 297

Consecutively assigned? No

Results/subgroup analysis (relevant to question): Over three years, 734 patients underwent CTM for cervical disc disease. CTM findings identified cervical disc hernations (CDH) in 297 patients. Of the 297 patients, 280 were diagnosed with radiculopathy and 17 with myelopathy. At surgery, cervical disc hernations (CDH) were noted in 297 patients. In the 297 patients, surgical reports noted one or more prolapsed discs in 258, a prolapsed disk and spur in 38, and a prolapsed disk with a fractue in 1. CTM corresponded to surgical findings in than 260/280 patients with radiculopathy and in 17/17 patients with myelopathy. Surgery was performed in 22 patients on the basis of clinical

symptoms alone. Of these 22 patients, 19 had herniations not seen on CTM and three had no herniations based upon surgical findings and CTM. A soft tissue extradural deformity appeared to be present on CTM in seven patients who had no cervical abnormalities on surgical exploration. The authors concluded that imaging of cervical disc prolapse continues to be difficult and the results are not always specific. CTM is the most sensitive imaging examination. In critique, patients were not consecutively assigned. This study provides Level III evidence that CT myelography can identify 90% of cervical extruded disc herniations confirmed by surgery.

Author conclusions (relative to question): Imaging of cervical disc prolapse continues to be difficult and the results are not always specific. CTM is the most sensitive imaging examination, but the number of MRI studies were insufficient to allow a direct comparison

Houser OW, Level III Prospective Retrospective Critique of methodology: Onofrio BM, Nonconsecutive patients Miller GM, Type of Study design: case series Small sample size Folger WN, evidence: No consistently applied gold Smith PL, diagnostic Stated objective of study: To review the standard Kallman DA. surgical and CTM findings in patients with Poor reference standard/no gold Cervical Neural foraminal stenosis. standard applied Foraminal Lacked subgroup analysis Canal Stenosis Diagnostic test(s) studied: Other: - Computerized Clinical exam/history Tomographic Electromyography Work group conclusions: Myelography Myelogram Potential level: III Diagnosis. MRI Downgraded level: III Journal of CT Neurosurgery. CT/Myelogram Conclusions relative to question: Jul Other: This paper provides evidence 1993;79(1):84- that:during surgical exploration, there 88. Compared to: was limited correlation between CT Clinical exam/history myelography and foraminal stenosis. Electromyography Myelogram MRI CT CT/Myelogram Other: surgical findings

Gold standard? Yes No If “Yes,” please specify: surgical findings

Number of patients: 95, 134 stenotic foramina

Consecutively assigned? No

Results/subgroup analysis (relevant to question): CTM showed stenosis at the entrance in 70 (52%), within the canal itself in 37 (28%), and site not definitively identified in 27 (20%). At the entrance to the foramen, stenosis secondary to a cartilagenous cap was identified in 10 patients (8%), osteophyte in 17 (13%), synovial cyst in one, and a combination of bone and cartilagenous cap in 42 (31%). Within the canal, small bone spurs arising from the uncovertebral process contributed to stenosis in 29 instances, and from the facet joint in 8. Diagnosis on the basis of CTM was difficult because stenosis was evident as a bone spur in only 13% of cases, could not be distinguished from a disc prolapse in 39%, had to be distinguished from a congenitally narrowed foramen in 27% and was missed in 20%.

Author conclusions (relative to question): The diagnosis of foraminal stenosis on CTM is difficult.

Evidentiary Table ● Cervical Radiculopathy from Degenerative Disorders, Outcome Measures

What are the most appropriate outcome measures to evaluate the treatment of cervical radiculopathy from degenerative disorders?

Article Level Description of study Conclusion (Alpha by of Author) evidence

Alrawi MF, Level III Prospective Retrospective Critique of methodology: Khalil NM, Nonrandomized Mitchell P, Type of Study design: observational Nonmasked reviewers Hughes SP. evidence: Nonmasked patients The value of prognostic Stated objective of study: To use No Validated outcome measures neurophysiologi neurophysiological electromyography used: cal and imaging (EMG) to predict outcome after ACDF. Small sample size studies in <80% follow-up predicting Type of treatment(s): ACDF with a cage Patients enrolled at different points outcome in the in their disease surgical Total number of patients: 20 Lacked subgroup analysis treatment of Number of patients in relevant Other: Patients still received an cervical subgroup(s): 12 with no evidence of nerve operation even if they had a radiculopathy. root involvement/8 with evidence of nerve negative EMG. Eur Spine J. root involvement Apr Work group conclusions: 2007;16(4):495- Consecutively assigned? Yes Potential level: II 500. Downgraded level: III Duration/intervals of follow-up: minimum 12 months Conclusions relative to question: This paper provides evidence that:the Outcome measure(s) implemented modified Prolo scale can be used to assess patient outcome after ACDF Neck Disability Index (NDI) SF-36 Visual Analog Scale (VAS), Pain Visual Analog Scale (VAS), Satisfaction Odom’s Criteria Zung Depression Scale Sickness Impact Profile (SIP) Neurologic Exam Radiographic Follow-Up Device Success Adverse Event Occurrence Return to Work Other: Prolo (modified), patient satisfaction grade

Results/subgroup analysis (relevant to question): Patients' outcome as measured with a modified Prolo scale was better predicted by EMG.

Author conclusions (relative to question): EMG can better predict outcomes as measured by a modified Prolo scale.

Anderberg L, Level II Prospective Retrospective Critique of methodology: Annertz M, Nonrandomized Brandt L, Type of Study design: observational Nonmasked reviewers Saveland H. evidence: Nonmasked patients Selective prognostic Stated objective of study: To correlate No Validated outcome measures diagnostic selective nerve root block (SNRB) with used: cervical nerve MRI findings and clinical symptoms. Small sample size root block-- <80% follow-up correlation with Type of treatment(s): SNRB with Patients enrolled at different points clinical Mepivacaine in their disease symptoms and Lacked subgroup analysis MRI-pathology. Total number of patients: 20 Other: Duration of symptoms 1-60 Acta Neurochir Number of patients in relevant months (Wien). Jun subgroup(s): 20 2004;146(6):55 9-565; Consecutively assigned? Yes Work group conclusions: discussion 565. Potential level: I Duration/intervals of follow-up: Downgraded level: II immediate-30 minutes Conclusions relative to question: Outcome measure(s) implemented: This paper provides evidence Neck Disability Index (NDI) that:VAS pain scale can be used to SF-36 document the immediate anesthetic Visual Analog Scale (VAS), Pain response to SNRB for radicular arm Visual Analog Scale (VAS), pain. Satisfaction Odom’s Criteria Zung Depression Scale Sickness Impact Profile (SIP) Neurologic Exam Radiographic Follow-Up Device Success Adverse Event Occurrence Return to Work Other:

Results/subgroup analysis (relevant to question): 86% mean reduction in VAS arm scores; 65% mean reduction in VAS neck scores.

Author conclusions (relative to question):

The VAS can be used to document response to anesthetic phase of SNRB for arm (and neck) pain.

Cleland JA, Level I Prospective Retrospective Critique of methodology: Fritz JM, Nonrandomized Whitman JM, Type of Study design: observational Nonmasked reviewers Palmer JA. The evidence: Nonmasked patients reliability and prognostic Stated objective of study: Examine the No Validated outcome measures construct test-retest reliability, construct validity and used: validity of the minimum levels of detectable and Small sample size Neck Disability clinically important change for the Neck <80% follow-up Index and Disability Index (NDI) and Patient Specific Patients enrolled at different points patient specific Functional Scale (PSFS) in a cohort of in their disease functional scale patients with cervical radiculopathy. Lacked subgroup analysis in patients with Other: cervical Type of treatment(s): Physical therapy radiculopathy. Spine (Phila Pa Total number of patients: 38 Work group conclusions: 1976). Mar 1 Number of patients in relevant Potential level: I 2006;31(5):598- subgroup(s): 38 Downgraded level: I 602. Consecutively assigned? Yes Conclusions relative to question: This paper provides evidence Duration/intervals of follow-up: 13-31 that:PSFS may be better than the NDI days. Mean 21.5 days for the assessment of outcomes in patients with cervical radiculopathy. Outcome measure(s) implemented

Neck Disability Index (NDI) SF-36 Visual Analog Scale (VAS), Pain Visual Analog Scale (VAS), Satisfaction Odom’s Criteria Zung Depression Scale Sickness Impact Profile (SIP) Neurologic Exam Radiographic Follow-Up Device Success Adverse Event Occurrence Return to Work Other: PSFS

Results/subgroup analysis (relevant to question): Test-retest reliability was moderate for the NDI and high for the PSFS. The PSFS was more responsive to change than the NDI. The minimal detectable change for the NDI was 10.2 and for the PSFS was 2.1.

Author conclusions (relative to question): The PSFS exhibits superior reliability, construct validity, and responsiveness in this cohort of patients with cervical radiculopathy compared with the NDI.

Davis RA. A Level II Prospective Retrospective Critique of methodology: long-term Nonrandomized outcome study Type of Study design: observational Nonmasked reviewers of 170 evidence: Nonmasked patients surgically prognostic Stated objective of study: To assess the No Validated outcome measures treated patients outcome of posterior decompression for used: with ~~~~~ cervical radiculopathy. Small sample size compressive Notes: <80% follow-up cervical Type of treatment(s): Posterior Patients enrolled at different points radiculopathy. decompression in their disease Surg Neurol. Lacked subgroup analysis Dec Total number of patients: 170 Other: 1996;46(6):523- Number of patients in relevant 530; discussion subgroup(s): 170 Work group conclusions: 530-523. Potential level: II Consecutively assigned? No Downgraded level: II

Duration/intervals of follow-up: not stated Conclusions relative to question: This paper provides evidence that:the Outcome measure(s) implemented author's modified Prolo scale may be reasonable to assess outcomes for Neck Disability Index (NDI) cervical radiculopathy from SF-36 degenerative disorders. Visual Analog Scale (VAS), Pain Visual Analog Scale (VAS), Satisfaction Odom’s Criteria Zung Depression Scale Sickness Impact Profile (SIP) Neurologic Exam Radiographic Follow-Up Device Success Adverse Event Occurrence Return to Work Other: Prolo (modified)

Results/subgroup analysis (relevant to question): Patients who had sedentary occupations and housewives had significantly higher Prolo scores (p<0.001) than those who did strenuous work. In 86% of patients, outcome was good (defined as a Prolo score of 8 in 5%, 9 in 38% and 10 in 43%).

Author conclusions (relative to question): Although outcome studies must have subjective criteria, the Prolo scale is more objective and quantitative than currently used methods.

Fernandez- Level I Prospective Retrospective Critique of methodology: Fairen M, Sala Nonrandomized P, Dufoo M, Jr., Type of Study design: RCT Nonmasked reviewers Ballester J, evidence: Nonmasked patients Murcia A, prognostic Stated objective of study: To determine No Validated outcome measures Merzthal L. the effectiveness and safety of a tantalum used: Anterior implant in achieving anterior cervical Small sample size cervical fusion fusion following 1-level discectomy as <80% follow-up with tantalum treatment of degenerative cervical disc Patients enrolled at different points implant: a disease with radiculopathy. in their disease prospective Lacked subgroup analysis randomized Type of treatment(s): Anterior cervical Other: controlled discectomy and fusion with interbody study. Spine. implant of tantalum (n=28) or by means of Work group conclusions: Mar 1 autologous iliac bone graft and plating Potential level: I 2008;33(5):465- (n=33). Downgraded level: I 472. Total number of patients: 61 Conclusions relative to question: Number of patients in relevant This paper provides evidence subgroup(s): 28/33 that:NDI, VAS (arm) are instruments that can be used to assess the Consecutively assigned? Yes outcome of surgical intervention for cervical radiculopathy from Duration/intervals of follow-up: 24 months degenerative disorders. Additionally, patient satisfaction as measured by Outcome measure(s) implemented Odom's criteria and depression as measured by the ZDS appears useful. Neck Disability Index (NDI) SF-36 Visual Analog Scale (VAS), Pain Visual Analog Scale (VAS), Satisfaction Odom’s Criteria Zung Depression Scale Sickness Impact Profile (SIP) Neurologic Exam Radiographic Follow-Up Device Success Adverse Event Occurrence Return to Work Other:

Results/subgroup analysis (relevant to question): At 24 months, radiologic and

clinical outcomes were similar for both treatments without significant difference. The safety of fusion with tantalum implant was documented

Author conclusions (relative to question): Clinical outcome using the VAS, NDI and Zung Depression Scale (ZDS) showed that tantalum implant is equivalent to autogenous graft and anterior plate.

Foley KT, Mroz Level II Prospective Retrospective Critique of methodology: TE, Arnold PM, Nonrandomized et al. Type of Study design: RCT Nonmasked reviewers Randomized, evidence: Nonmasked patients prospective, prognostic Stated objective of study: To determine No Validated outcome measures and controlled the efficacy and safety of pulsed used: clinical trial of electromagnetic field (PEMF) stimulation Small sample size pulsed as an adjunct to arthrodesis after ACDF in <80% follow-up electromagnetic patients with potential risk factors for Patients enrolled at different points field stimulation nonunion. in their disease for cervical Lacked subgroup analysis fusion. Spine Type of treatment(s): ACDF with PEMF Other: Journal. May 2008;8(3):436- Total number of patients: 323 Work group conclusions: 442. Number of patients in relevant Potential level: II subgroup(s): 163/160 Downgraded level: II

Consecutively assigned? Yes Conclusions relative to question: This paper provides evidence Duration/intervals of follow-up: 12 months that:NDI, VAS (arm) and SF-12 can be used to assess outcome after Outcome measure(s) implemented surgical intervention for cervical radiculopathy from degenerative Neck Disability Index (NDI) disorders. SF-36 Visual Analog Scale (VAS), Pain Visual Analog Scale (VAS), Satisfaction Odom’s Criteria Zung Depression Scale Sickness Impact Profile (SIP) Neurologic Exam Radiographic Follow-Up Device Success Adverse Event Occurrence Return to Work Other: SF-12

Results/subgroup analysis (relevant to question): Clinical outcome as measured

with the NDI, VAS (arm) and SF-12 showed that PEMF and control groups had no significant differences in outcome.

Author conclusions (relative to question): Clinical outcome as measured with the NDI, VAS (arm) and SF-12 showed that PEMF and control groups had no significant differences in outcome.

Hacker RJ, Level I Prospective Retrospective Critique of methodology: Cauthen JC, Nonrandomized Gilbert TJ, Type of Study design: RCT Nonmasked reviewers Griffith SL. A evidence: Nonmasked patients prospective prognostic Stated objective of study: To report No Validated outcome measures randomized clinical results with maximum 24-month used: multicenter follow-up of fusions performed with the Small sample size clinical BAK/C fusion cage. <80% follow-up evaluation of an Patients enrolled at different points anterior cervical Type of treatment(s): ACDF with BAK/C in their disease fusion cage. cage Lacked subgroup analysis Spine. Oct 15 Other: 2000;25(20):26 Total number of patients: 344 46-2654; Number of patients in relevant Work group conclusions: discussion subgroup(s): 239/105 Potential level: I 2655. Downgraded level: I Consecutively assigned? Yes Conclusions relative to question: Duration/intervals of follow-up: 344 at This paper provides evidence one year, 180 at 2 years that:VAS and SF-36 can be used to assess outcome following surgery for Outcome measure(s) implemented cervical radiculopathy.

Results/subgroup analysis (relevant to question): Clinical outcome as assessed with the VAS and SF-36 showed that

with the NDI, VAS (arm) and SF-12 showed that PEMF and control groups had no significant differences in outcome.

Author conclusions (relative to question): Clinical outcome as measured with the NDI, VAS (arm) and SF-12 showed that PEMF and control groups had no significant differences in outcome.

Results/subgroup analysis (relevant to question): Clinical outcome as assessed with the VAS and SF-36 showed that

Results/subgroup analysis (relevant to question): Statistically significant improvements were found in postoperative scores for bodily pain (p<0.001), vitality (p=0.003), physical function (p=0.01), role function/physical (p=0.0003) and social function (p=0.0004). No significant differences were found for three health scales: general health, mental health and role function associated with emotional limitations.

Author conclusions (relative to question): HSQ may be a good disease specific outcome tool for one and two level ACDF.

Kumar N, Level II Prospective Retrospective Critique of methodology: Gowda V. Nonrandomized Cervical Type of Study design: observational Nonmasked reviewers foraminal evidence: Nonmasked patients selective nerve prognostic Stated objective of study: To highlight the No Validated outcome measures root block: a effectiveness and safety of cervical used: 'two-needle selective nerve root block using a two Small sample size technique' with needle technique for treatment of <80% follow-up results. Eur radiculopathy. Patients enrolled at different points Spine J. Apr in their disease 2008;17(4):576- Type of treatment(s): SNRB Lacked subgroup analysis 584. Other: Total number of patients: 33 Number of patients in relevant Work group conclusions: subgroup(s): 33 Potential level: II Downgraded level: II Consecutively assigned? No Conclusions relative to question: Duration/intervals of follow-up: 2 years, This paper provides evidence but only one year follow-up data on that:NDI, VAS and SF-36 can be used outcomes to assess outcome of cervical radiculopathy from degenerative Outcome measure(s) implemented disorders.

Device Success Adverse Event Occurrence Return to Work Other:

Results/subgroup analysis (relevant to question): Statistical improvements in VAS score and NDI score were seen at 6 weeks and 12 months after the procedure.

Author conclusions (relative to question): The VAS score and NDI can be used to show that the two-needle technique of cervical foraminal SNRB produces improved outcomes at 6 weeks and 12 months.

Lofgren H, Level I Prospective Retrospective Critique of methodology: Johansen F, Nonrandomized Skogar O, Type of Study design: observational Nonmasked reviewers Levander B. evidence: Nonmasked patients Reduced pain prognostic Stated objective of study: To follow the No Validated outcome measures after surgery for clinical outcome after surgery for cervical used: cervical disc radiculopathy caused by cervical DDD Small sample size protrusion/sten and to compare it with the outcome after <80% follow-up osis: a 2 year conservative treatment Patients enrolled at different points clinical follow- in their disease up. Disabil Type of treatment(s): ACDF (Cloward- Lacked subgroup analysis Rehabil. Sep 16 single level), conservative treatment Other: question of selection bias in 2003;25(18):10 group selection; conservative 33-1043. Total number of patients: 43 treatment not stated Number of patients in relevant subgroup(s): 43 ACDF-Cloward, Work group conclusions: 39 Conservative controls (2 did have Potential level: I surgery) Downgraded level: I

Consecutively assigned? Yes Conclusions relative to question: This paper provides evidence that:SIP Duration/intervals of follow-up: 2 year and VAS (arm) may be useful surgical duration with follow-up at 3, 9 and 24 outcome measures for patients with months cervical radiculopathy.

Outcome measure(s) implemented

Neck Disability Index (NDI) SF-36 Visual Analog Scale (VAS), Pain Visual Analog Scale (VAS), Satisfaction Odom’s Criteria

Zung Depression Scale Sickness Impact Profile (SIP) Neurologic Exam Radiographic Follow-Up Device Success Adverse Event Occurrence Return to Work Other: Sickness Impact Profile (SIP)

Results/subgroup analysis (relevant to question): Pain reduction measured with VAS was more pronounced among the operated patients at the final follow-up for maximal neck pain (ρ=0.03) and at 3 months and 9 months, respectively for average neck pain (ρ=0.02, both). Initially, there was no statistically significant difference in pain intensity between the surgically and conservatively treated groups. SIP scheduled for surgery had higher sickness impact in the overall index.

Author conclusions (relative to question): Operated patients demonstrated an improvement in pain (VAS) and in SIP, as well as at the clinical examination, all indicating a true improvement, although it was only partially maintained.

Mummaneni Level II Prospective Retrospective Critique of methodology: PV, Burkus JK, Nonrandomized Haid RW, Study design: RCT Nonmasked reviewers Traynelis VC, Type of Nonmasked patients Zdeblick TA. evidence: Stated objective of study: To compare the No Validated outcome measures Clinical and prognostic results of cervical disc arthroplasty to used: radiographic ACDF Small sample size analysis of <80% follow-up cervical disc Type of treatment(s): Prestige Artificial Patients enrolled at different points arthroplasty Cervical Disc Replacement in their disease compared with Lacked subgroup analysis allograft fusion: Total number of patients: 541 Other: Use of arthrosis in ACDF&P a randomized Number of patients in relevant group, <80%follow-up: 80%in controlled subgroup(s): 276 - Prestige disc, 265 - Prestige treatment group, and 75% clinical trial. J ACDF & Plating in ACDF&P control group Neurosurg Spine. Mar Consecutively assigned? No Work group conclusions: 2007;6(3):198- Potential level: I 209. Duration/intervals of follow-up: 2 year Downgraded level: II duration with follow-up at 1.5, 3, 6, 12 and 24 months Conclusions relative to question:

Outcome measure(s) implemented: This paper provides evidence Neck Disability Index (NDI) that:NDI and SF-36 can be used to SF-36 assess the outcomes of cervical Visual Analog Scale (VAS), Pain radiculopathy treated by discectomy Visual Analog Scale (VAS), and artifical disc replacement or Satisfaction fusion. Odom’s Criteria Zung Depression Scale Sickness Impact Profile (SIP) Neurologic Exam Radiographic Follow-Up Device Success Adverse Event Occurrence Return to Work Other: Neck and arm pain numeric rating(VAS)

Results/subgroup analysis (relevant to question): Neck pain, arm pain and NDI scores were improved in the Prestige disc group. Success rates at 12 and 24 months for Prestige were statistically superior to control group. Neck pain improved in both treatment groups, but statistically significant in Prestige group at 6 weeks, 3 months and 12 months. No significant intergroup differences in arm pain or return to work at 24 months. NDI score was statistically significantly higher only at 3 months, but tended to have higher score than control.

Author conclusions (relative to question): The Prestige ST-cervical disc system maintained physiological segmental motion at 24 months after implantation and was associated with improved neurologic success, improved clinical outcomes (SF-36) and reduced rate of secondary surgeries Compared to: ACDF.

Evidentiary Table ● Cervical Radiculopathy from Degenerative Disorders, Medical/Interventional Treatment

What is the role of physical therapy/exercise in the treatment of cervical radiculopathy from degenerative disorders?

Article Level (Alpha by of Description of study Conclusion Author) evidence

Persson LC, Level II Prospective Retrospective Critique of methodology: Lilja A. Pain, Nonconsecutive patients coping, Type of Study design: RCT Nonrandomized emotional state evidence: Nonmasked reviewers and physical therapeutic Stated objective of study: To compare Nonmasked patients function in coping strategies, pain and emotional No Validated outcome measures patients with relationships of patients with cervical used: chronic radiculopathy of at least three months Small sample size radicular neck duration randomly assigned to one of Inadequate length of follow-up pain. A three treatment groups. <80% follow-up comparison Lacked subgroup analysis between Type of treatment(s): Cervical brace, Diagnostic method not stated patients treated physical therapy (PT), and anterior Other: with surgery, cervical decompression and fusion physiotherapy (ACDF) Work group conclusions: or neck collar-- Potential level: I a blinded, Total number of patients: 81 Downgraded level: II prospective Number of patients in relevant randomized subgroup(s): 27 in each group Conclusions relative to question: study. Disabil This paper provides evidence that: Rehabil. May Consecutively assigned? Yes there is a high incidence of behavioral 20 and emotional dysfunction in cervical 2001;23(8):325- Duration of follow-up: 16 months radiculopathy patients. 335. Medical/interventional and surgical Validated outcome measures used: VAS treatment must include a cognitive, pain score, Hospital Anxiety and behavioral component for either Depression scale (HAD), Mood Adjective method to be successful. Check List (MACL), general coping questionnaire, and Disability Rating Index (DRI).

Nonvalidated outcome measures used:

Diagnosis of cervical radiculopathy made by:

Clinical exam/history Electromyography

Myelogram MRI CT CT/Myelogram Other: behavioral and functional outcomes

Results/subgroup analysis (relevant to question): Three patients assigned to the surgical group refused the procedure and were handled in intent to treat analysis. In the surgical group, eight patients had a second operation: six on adjacent level, one infection and one plexus exploration. Eleven patients in the surgery group also received physical therapy. One patient in the physical therapy group and five in the collar group had surgery with Cloward technique. Chronic symptoms influenced both function and mental well being such as emotional state, level of anxiety, depression, sleep and coping behavior. Pain was the most important primary stressor. Surgery reduced the pain faster, but no difference was seen after 12 months. Reoperation rate was 29%, mostly for adjacent segment disease. The low positive mood state (MACL score) did not improve over time. Patients who still had pain after treatment were more socially withdrawn and ceased to express their emotions. The Hospital Anxiety and Depression (HAD) anxiety score was especially high in patients before and after treatment. In patients with high pain intensity, low function, high depression and anxiety were seen. The group treated with surgery showed more anxiety and depression if pain continued, implying higher expectations and more disappointment if it failed. The strongest correlation between depression and pain was seen in the collar group, possibly because they received less attention overall. In general, coping strategies changed. Active coping was common before treatment, but disappeared after treatment, especially in the surgical group. Coping with pain was changed in general into a more passive/escape focused strategy. Also used less alcohol.

Function was significantly related to pain intensity. About 40% had anxiety only partially connected to pain. Prior to treatment, 30% of patients were depressed. After 12 months, 20% suffered from depression.

Author conclusions (relative to question): Cognitive and behavioral therapy is important to include in multidisciplinaryy rehabilitation. Patients need to improve coping strategies, self image and mood.

Evidentiary Table ● Cervical Radiculopathy from Degenerative Disorders, Medical/Interventional Treatment

What is the role of epidural steroid injections for the treatment of cervical radiculopathy from degenerative disorders?

Article Level (Alpha by of evidence Description of study Conclusion Author) Anderberg L, Level II Prospective Retrospective Critique of methodology: Annertz M, Nonconsecutive patients Persson L, Type of Study design: RCT Nonrandomized Brandt L, evidence: Nonmasked reviewers Saveland H. therapeutic Stated objective of study: Evaluate role Nonmasked patients Transforaminal of transforaminal epidural steroid No Validated outcome measures steroid injections for pain relief following used: injections for successful SNRB Small sample size the treatment of Inadequate length of follow-up cervical Type of treatment(s): transforaminal <80% follow-up radiculopathy: a epidural injection with steroid/local Lacked subgroup analysis prospective and anesthetic or saline/local anesthetic Diagnostic method not stated randomised (control) Other: study. Eur Spine J. Mar Total number of patients: 40 Work group conclusions: 2007;16(3):321- Number of patients in relevant Potential level: I 328. subgroup(s): 20 Downgraded level: II

Consecutively assigned? Yes Conclusions relative to question: This paper provides evidence that:the Duration of follow-up: 3 weeks addition of steroids to a local anesthetic injection provides no Validated outcome measures used: additional therapeutic benefit at 3 VAS weeks post-procedure.

Nonvalidated outcome measures used: Follow-up questionairre

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other: selective nerve root block

Results/subgroup analysis (relevant to question):

Author conclusions (relative to question): Cyteval C, Level IV Prospective Retrospective Critique of methodology: Thomas E, Nonconsecutive patients Decoux E, et al. Type of Study design: case series Nonrandomized Cervical evidence: Nonmasked reviewers radiculopathy: therapeutic Stated objective of study: To evaluate Nonmasked patients open study on the feasability, tolerance, and efficacy No Validated outcome measures percutaneous of transforaminal periganglionic steroid used: periradicular infiltration under CT control Small sample size foraminal Inadequate length of follow-up steroid Type of treatment(s): transforaminal <80% follow-up infiltration epidural steroid injection Lacked subgroup analysis performed Diagnostic method not stated under CT Total number of patients: 30 Other: control in 30 Number of patients in relevant patients. AJNR subgroup(s): Work group conclusions: Am J Potential level: IV Neuroradiol. Consecutively assigned? Yes Downgraded level: IV Mar 2004;25(3):441- Duration of follow-up: 6 months Conclusions relative to question: 445. This paper provides evidence that:60% Validated outcome measures used: of patients obtain good or excellent used a modified VAS pain relief following a transforaminal (excellent/good/fair/poor) epidural steroid injection under CT guidance Nonvalidated outcome measures used:

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other:

Results/subgroup analysis (relevant to question): 60% of patients obtain good or excellent pain relief following a transforaminal epidural steroid injection under CT guidance

Author conclusions (relative to question): CT guided transforaminal ESI provided sustained relief regardless of the cause of radiculopathy Kim H, Lee SH, Level IV Prospective Retrospective Critique of methodology: Kim MH. Nonconsecutive patients

Multislice CT Type of Study design: case series Nonrandomized fluoroscopy- evidence: Nonmasked reviewers assisted therapeutic Stated objective of study: To evaluate Nonmasked patients cervical the feasibility and the outcome of No Validated outcome measures transforaminal cervical transforaminal epidural steroid used: injection of injection guided by multislice CT Small sample size steroids: Inadequate length of follow-up technical note. Type of treatment(s): transforaminal <80% follow-up J Spinal Disord epidural steroid injection Lacked subgroup analysis Tech. Aug Diagnostic method not stated 2007;20(6):456- Total number of patients: 19 Other: 461. Number of patients in relevant subgroup(s): 19 Work group conclusions: Potential level: IV Consecutively assigned? Yes Downgraded level: IV

Duration of follow-up: 4 months Conclusions relative to question: This paper provides evidence Validated outcome measures used: that:cervical transforaminal steroid VAS injections provide approximately a 50% reduction in pain which lasts for 16 Nonvalidated outcome measures used: weeks.

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other: excluded patients with neurologic deficit

Results/subgroup analysis (relevant to question): No patient required more than 2 injections. Significant improvement in VAS at 2, 4, 8, 16 weeks. No serious complications.

Author conclusions (relative to question): CT guided cervical transforaminal epidural steroid injections are safe and effective. Kolstad F, Level IV Prospective Retrospective Critique of methodology: Leivseth G, Nonconsecutive patients Nygaard OP. Type of Study design: case series Nonrandomized Transforaminal evidence: Nonmasked reviewers steroid therapeutic Stated objective of study: To determine Nonmasked patients injections in the if transforaminal steroid injections No Validated outcome measures treatment of applied to a cohort of patients waiting used:

cervical for cervical disc surgery, reduce the Small sample size radiculopathy. pain of cervical radiculopathy and Inadequate length of follow-up A prospective hence reduce the need for surgical <80% follow-up outcome study. intervention. Lacked subgroup analysis Acta Neurochir Diagnostic method not stated (Wien). Oct Type of treatment(s): 2 cervical Other: 2005;147(10):1 transforaminal steroid injections, 2 065-1070; weeks apart Work group conclusions: discussion Potential level: IV 1070. Total number of patients: 21 Downgraded level: IV

Number of patients in relevant Conclusions relative to question: subgroup(s): This paper provides evidence that:about 1/4 of patients who could Consecutively assigned? be considered for surgery could potentially achieve short term pain Duration of follow-up: 4 months relief with 2 cervical transforaminal epidural steroid injections two weeks Validated outcome measures used: apart. VAS

Nonvalidated outcome measures used: Odom's criteria, operative indications

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other:

Results/subgroup analysis (relative to question):

Author conclusions (relative to question): Lin EL, Lieu V, Level IV Prospective Retrospective Critique of methodology: Halevi L, Nonconsecutive patients Shamie AN, Type of Study design: case series Nonrandomized Wang JC. evidence: Nonmasked reviewers Cervical therapeutic Stated objective of study: To examine Nonmasked patients epidural steroid the efficacy of cervical epidural steroid No Validated outcome measures injections for injections for the treatment of used: symptomatic symptomatic herniated cervical discs in Small sample size disc patients considered potential surgical Inadequate length of follow-up herniations. candidates. <80% follow-up Journal of Lacked subgroup analysis Spinal Type of treatment(s): cervical Diagnostic method not stated

Disorders and transforaminal epidural steroid Other: Techniques. injections using fluoroscopic guidance May Work group conclusions: 2006;19(3):183- Total number of patients: 70 Potential level: IV 186. Downgraded level: IV Number of patients in relevant subgroup(s): Conclusions relative to question: This paper provides evidence Consecutively assigned? Yes that:approximately 60% of patients who are considered surgical Duration of follow-up: 1 year candidates may obtain pain relief from cervical epidural steroid injections. Validated outcome measures used: main outcome measure was whether or not surgery was performed

Nonvalidated outcome measures used: Odom's

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other:

Results/subgroup analysis (relevant to question): older patients and those with shorter duration of symptoms did better with ESI

Author conclusions (relative to question): Patients considering surgery may improve with a trial of ESI and avoid surgery

Evidentiary Table ● Cervical Radiculopathy from Degenerative Disorders, Medical/Interventional Treatment

What is the role of ancillary treatments such as bracing, traction, electrical stimulation, acupuncture and transcutaneous electrical stimulation (TENS) in the treatment of cervical radiculopathy from degenerative disorders?

Article Level (Alpha by of evidence Description of study Conclusion Author) Alexandre A, Level V Prospective Retrospective Critique of methodology: Coro L, Azuelos Nonconsecutive patients A, et al. Type of Study design: case series Nonrandomized Intradiscal evidence: Nonmasked reviewers injection of therapeutic Stated objective of study: Report the Nonmasked patients oxygen-ozone effects of intervertebral disc and No Validated outcome measures gas mixture for paravertebral injections of ozone & used: the treatment of oxygen in patients with cervical disc Small sample size cervical disc herniations Inadequate length of follow-up herniations. <80% follow-up Acta Neurochir Type of treatment(s): Intervertebral Lacked subgroup analysis Suppl. disc and five paravertebral injections of Diagnostic method not stated 2005;92:79-82. ozone & oxygen Other: No specified duration of follow-up, no data tables or speed Total number of patients: 252 of recovery noted.

Number of patients in relevant Work group conclusions: subgroup(s): Potential level: IV Downgraded level: V Consecutively assigned? No Conclusions relative to question: Duration of follow-up: possibly 7 This paper provides evidence months that:Approximately 80% of patients will report symptomatic relief from cervical Validated outcome measures used: radiculopathy at some point following ozone and oxygen injection into the Nonvalidated outcome measures used: intervertebral disc and paravertebral pain improvement, sensory musculature. dysfunction, strength improvement

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other:

Results/subgroup analysis (relevant to question):

Author conclusions (relative to question): Approximately 80% of patients reported relief of symptoms at some point following the injection procedure.

Olivero WC, Level V Prospective Retrospective Critique of methodology: Dulebohn SC. Nonconsecutive patients Results of Type of Study design: case series Nonrandomized halter cervical evidence: Nonmasked reviewers traction for the therapeutic Stated objective of study: Evaluate the Nonmasked patients treatment of use of halter traction and collar in No Validated outcome measures cervical patients with cervical radiculopathy used: radiculopathy: Small sample size retrospective Type of treatment(s): traction for 6 Inadequate length of follow-up review of 81 weeks - additional traction if improving; <80% follow-up patients. (8-12 lbs, TID for 15 minutes) cervical Lacked subgroup analysis Neurosurg collar. Patients with severe symptoms Diagnostic method not stated Focus. Feb 15 excluded from study. Other: 2002;12(2):EC P1. Total number of patients: 81 Work group conclusions: Potential level: IV Number of patients in relevant Downgraded level: V subgroup(s): Conclusions relative to question: Consecutively assigned? No This paper provides evidence that:75% of patients with mild radiculopathy may Duration of follow-up: 6-12 weeks improve with traction over a six week time frame. Validated outcome measures used: none

Nonvalidated outcome measures used: patient report of pain relief

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other:

Results/subgroup analysis (relevant to question): 63 (78%) of patients responded to traction

3 patients who initially responded relapsed

Author conclusions (relative to question): 75% of patients with mild cervical radiculopathy of approximately 6 weeks duration may improve with halter traction Persson LC, Level II Prospective Retrospective Critique of methodology: Lilja A. Pain, Nonconsecutive patients coping, Type of Study design: RCT Nonrandomized emotional state evidence: Nonmasked reviewers and physical therapeutic Stated objective of study: To compare Nonmasked patients function in coping strategies, pain and emotional No Validated outcome measures patients with relationships of patients with cervical used: chronic radiculopathy of at least three months Small sample size radicular neck duration randomly assigned to one of Inadequate length of follow-up pain. A three treatment groups. <80% follow-up comparison Lacked subgroup analysis between Type of treatment(s): Cervical brace, Diagnostic method not stated patients treated physical therapy (PT), and anterior Other: with surgery, cervical decompression and fusion physiotherapy (ACDF) Work group conclusions: or neck collar-- Potential level: I a blinded, Total number of patients: 81 Downgraded level: II prospective Number of patients in relevant randomized subgroup(s): 27 in each group Conclusions relative to question: study. Disabil This paper provides evidence that: Rehabil. May Consecutively assigned? Yes there is a high incidence of behavioral 20 and emotional dysfunction in cervical 2001;23(8):325- Duration of follow-up: 16 months radiculopathy patients. 335. Medical/interventional and surgical Validated outcome measures used: treatment must include a cognitive, VAS pain score, Hospital Anxiety and behavioral component for either Depression scale (HAD), Mood method to be successful. Adjective Check List (MACL), general coping questionnaire, and Disability Rating Index (DRI).

Nonvalidated outcome measures used:

Diagnosis of cervical radiculopathy made by:

Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other: behavioral and functional

outcomes

had anxiety only partially connected to pain. Prior to treatment, 30% of patients were depressed. After 12 months, 20% suffered from depression.

Saal JS, Saal Level IV Prospective Retrospective Critique of methodology: JA, Yurth EF. Nonconsecutive patients Nonoperative Type of Study design: case series Nonrandomized management of evidence: Nonmasked reviewers herniated therapeutic Stated objective of study: report Nonmasked patients cervical success of a conservative No Validated outcome measures intervertebral management program for cervical used: disc with radiculopathy Small sample size radiculopathy. Inadequate length of follow-up Spine. Aug 15 Type of treatment(s): PT, NSAIDs, po <80% follow-up 1996;21(16):18 steroids, ESI, exercise, postural Lacked subgroup analysis 77-1883. training, collar, acupuncture, TENS Diagnostic method not stated Other: Total number of patients: 26; 24/26 completed program Work group conclusions: Number of patients in relevant Potential level: IV subgroup(s): Downgraded level: IV

Consecutively assigned? Yes Conclusions relative to question: This paper provides evidence that:a Duration of follow-up: 3 months multifaceted medical/interventional treatment program is associated with Validated outcome measures used: good outcomes in many patients with none cervical radiculopathy.

Nonvalidated outcome measures used: patient questionaire, return to work

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other:

Results/subgroup analysis (relevant to question): 24 completed program 22/24 returned to work 89% had good/excellent response

Author conclusions (relative to question): Comprehensive nonoperative treatment program was associated with favorable results in treating cervical radiculopathy

Evidentiary Table ● Cervical Radiculopathy from Degenerative Disorders, Surgical Treatment

Does surgical treatment (with or without preoperative medical/interventional treatment) result in better outcomes than medical/interventional treatment for cervical radiculopathy from degenerative disorders?

Article Level (Alpha by of Description of study Conclusion Author) evidence

Nonvalidated outcome measures used:

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram

MRI CT CT/Myelogram Other: behavioral and functional outcomes

intensity. About 40% had anxiety only partially connected to pain. Prior to treatment, 30% of patients were depressed. After 12 months, 20% suffered from depression.

Persson LC, Level II Prospective Retrospective Critique of methodology: Moritz U, Nonconsecutive patients Brandt L, Type of Study design: RCT Nonrandomized Carlsson CA. evidence: Nonmasked reviewers Cervical therapeutic Stated objective of study: To compare Nonmasked patients radiculopathy: outcomes in pain, strength and sensation No Validated outcome measures pain, muscle in three treatment groups of patients with used: weakness and cervical radiculopathy of a minimum of Small sample size sensory loss in three months duration Inadequate length of follow-up patients with <80% follow-up cervical Type of treatment(s): Cervical brace, Lacked subgroup analysis radiculopathy physical therapy (PT), and anterior Diagnostic method not stated treated with cervical decompression and fusion Other: surgery, (ACDF) (Cloward technique) physiotherapy Work group conclusions: or cervical Total number of patients: 81 Potential level: I collar. A Number of patients in relevant Downgraded level: II prospective, subgroup(s): 27 in each group. controlled Conclusions relative to question: study. Eur Consecutively assigned? Yes This paper provides evidence that:at Spine J. one year, outcomes are similar for 1997;6(4):256- Duration of follow-up: 16 months medical/interventional treatment and 266. surgical treatment of patients with Validated outcome measures used: VAS cervical radiculopathy from pain scale, muscle strength assessed by degenerative disorders. Due to the a handheld dynamometer, vigorometer small sample size, one may not and pinchometer. Sensory loss recorded expect to see a difference between the groups on a statistical basis. Nonvalidated outcome measures used: Surgical treatment resulted in improved outcomes earlier in the Diagnosis of cervical radiculopathy made postoperative treatment period when by: compared with the Clinical exam/history medical/interventional treatment Electromyography group. Myelogram MRI CT CT/Myelogram Other:

Results/subgroup analysis (relevant to question): Three surgical patients refused the procedure and were handled in intent to treat analysis. In the surgical group, eight patients had a second operation: six on adjacent level, one infection and one plexus exploration. Eleven patients in the surgery group also received physical therapy. One patient in the physical therapy group and five in the collar group had surgery with Cloward technique. Strength measurements were all performed by one physical therapist with standard protocol. Physical therapy was done for 15 visits and was not standardized. Several different collars were used and worn for three months. At four month follow-up, pain was improved in the surgical and physical therapy groups, and improvement in pain scores in the surgical group was significantly better than in the collar group. After another year, the pain was about the same across groups. The surgical group improved strength a little faster, but at final follow-up strength improvement was equal across groups. At final follow-up, there was no difference between groups on the sensory exam.

Author conclusions (relative to question): No difference in outcomes after one year between patients treated with a collar, physical therapy or surgery.

Sampath P, Level III Prospective Retrospective Critique of methodology: Bendebba M, Nonconsecutive patients Davis JD, Type of Study design: comparative Nonrandomized Ducker T. evidence: Nonmasked reviewers Outcome in therapeutic Stated objective of study: Evaluated Nonmasked patients patients with clinical outcomes in patients with cervical No Validated outcome measures cervical radiculopathy used: radiculopathy. Small sample size Prospective, Type of treatment(s): Inadequate length of follow-up multicenter Medical/interventional treatment was <80% follow-up study with nonstandardized in this multicenter trial, Lacked subgroup analysis independent and included medications, steroids, bed Diagnostic method not stated clinical review. rest, exercise, traction, bracing, injections, Other: high attrition rate, Spine. Mar 15 chiropractic care, acupuncture and medical/interventional and surgical 1999;24(6):591- homeopathic medicine. Surgery included treatment protocols were

597. foraminotomy, anterior cervical nonstandardized/variable. decompression (ACD), and anterior cervical decompression and fusion Work group conclusions: (ACDF). Potential level: II Downgraded level: III Total number of patients: 503 Number of patients in relevant Conclusions relative to question: subgroup(s): 246, 160 medical, 86 This paper provides evidence surgical. Nonrandomized from 41 different that:surgical treatment results in surgeons. improved outcomes when compared with medical/interventional treatment Consecutively assigned? No on short term follow-up.

Duration of follow-up: Mean 11 months (range: 8 to 13 months)

Validated outcome measures used:

Nonvalidated outcome measures used: Pain scale, satisfaction scale, neurologic score, functional scale, activities of daily living (ADL) scale.

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other: Imaging not stated

Results/subgroup analysis (relevant to question): Of the 246 patients, only 155 reported data at final follow-up. Of the 155 patients, 104 were medically/interventionally treated and 51 had surgery. In general, pain scores were worse in the surgical group preoperatively than in the medical/interventional treatment group. Both groups improved significantly, with greater improvement seen in the surgical group. Patient satisfaction, neurological improvement and functional improvement were seen in both groups, with greater improvement reported in the surgical group. There was significant improvement in activities of daily living (ADL) in the surgical group. Although there was improvement, there

was still significant pain in about 26% of surgical patients. The number returning to work did not differ before and after intervention in either group despite improved functional ability, implying that the most important factor for return to work was work status prior to treatment.

Author conclusions (relative to question): Surgery appears to have more success than medical/interventional treatment, although both help. Despite this, a substantial percentage of patients continue to have severe pain, neurologic symptoms and no work activity.

Evidentiary Table ● Cervical Radiculopathy from Degenerative Disorders, Surgical Treatment

Does anterior cervical decompression with fusion result in better outcomes (clinical or radiographic) than anterior cervical decompression alone?

Article Level (Alpha by of evidence Description of study Conclusion Author) Barlocher CB, Level III Prospective Retrospective Critique of methodology: Barth A, Krauss Nonconsecutive patients JK, Binggeli R, Type of Study design: RCT Nonrandomized Seiler RW. evidence: Nonmasked reviewers Comparative therapeutic Stated objective of study: Compare Nonmasked patients evaluation of outcomes of anterior cervical No Validated outcome measures microdiscectom decompression (ACD) to three different used: y only, autograft types of anterior cervical decompression Small sample size fusion, and fusion (ACDF): iliac crest bone graft Inadequate length of follow-up polymethylmeth (ICBG), polymethylmethacrylate (PMMA) <80% follow-up acrylate and titanium cages. Lacked subgroup analysis interposition, Diagnostic method not stated and threaded Type of treatment(s): ACD vs ACDF Other: Single level disease only, titanium cage PMMA as spacer is not standard fusion for Total number of patients: 125 practice, randomization process is treatment of Number of patients in relevant not described single-level subgroup(s): 33 ACD, 30 ICBG, 26 cervical disc PMMA, and 36 cages Work group conclusions: disease: a Potential level: II prospective Consecutively assigned? Yes Downgraded level: III randomized study in 125 Duration of follow-up: 12 months Conclusions relative to question: patients. This paper provides evidence Neurosurg Validated outcome measures used: that:suggests that there are variable Focus. Jan 15 outcomes when comparing ACD to 2002;12(1):E4. Nonvalidated outcome measures used: ACDF for the treatment of cervical Odom Criteria, VAS pain scale radiculopathy due to single level degenerative disease. In one cohort Diagnosis of cervical radiculopathy made comparing ACD to fusion with ICBG, by: outcomes were equivalent, while Clinical exam/history another cohort showed superiority of Electromyography interbody fusion with a titanium cage Myelogram and allograft versus ACD. Validity of MRI conclusions are weakened by small CT sample size and short follow-up. CT/Myelogram Other: Used imaging; not specified

Results/subgroup analysis (relevant to question): Of the 125 patients, 123 were

available for follow-up. The functional outcomes were grouped by good and excellent to poor and fair, with good/excellent results reported for 75% of the ACDF group, 80% for ICBG, 87% for PMMA and 94% for cage. Average reported kyphosis for ACD patients was 24 degrees, with one patient requiring revision surgery (31 degrees); 12 degrees for PMMA and about three degrees for the ICBG and cage groups. Twelve month fusion results were reported as 93% for the ACD patients, 93% for ICBG and 97% for cage . Fusion rate was faster in the cage group as well with 86% achieving fusion at six months compared with 61% in the ACD group and 65% in the ICBG group.

Author conclusions (relative to question): Concluded that ACDF with cage did significantly better with faster and better recovery and less kyphotic deformity than ACD. ACD Compared to: ICBG had similar outcomes at medium length follow- up. Hauerberg J, Level II Prospective Retrospective Critique of methodology: Kosteljanetz M, Nonconsecutive patients Boge- Type of Study design: RCT Nonrandomized Rasmussen T, evidence: Nonmasked reviewers et al. Anterior therapeutic Stated objective of study: Compare Nonmasked patients cervical radiographic and clinical outcomes of No Validated outcome measures discectomy with ACD with ACDF using a titanium cage. used: or without Small sample size fusion with ray Type of treatment(s): anterior cervical Inadequate length of follow-up titanium cage: a discectomy (ACD), anterior cervical <80% follow-up prospective discectomy with fusion ( ACDF) at one Lacked subgroup analysis randomized level only in subaxial cervical spine Diagnostic method not stated clinical study. Other: Spine. Mar 1 Total number of patients: 86 2008;33(5):458- Number of patients in relevant Work group conclusions: 464. subgroup(s): 46 ACD and 40 ACDF Potential level: I Downgraded level: II Consecutively assigned? Yes Conclusions relative to question: Duration of follow-up: minimum two years This paper provides evidence that: for cervical radiculopathy due to single Validated outcome measures used: level degenerative disease, clinical none outcomes are similar at two years for patients undergoing ACD and ACDF Nonvalidated outcome measures used: with threaded titanium cage and local

four point scale, converted to autograft. Fusion rates and dichotomized scale of good/excellent vs. symptomatic adjacent segment unchanged/worse, numerical pain score, disease were also similar between the and return to work two groups.

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other: Imaging; not specified

Results/subgroup analysis (relevant to question): One patient withdrew in each group. Two year follow-up data were available for 36 cage and 43 ACD patients. Early outcomes, though not statistically significant, favored ACD. At two years 63% of ACD patients and 78% of cage patients reported good outcomes (not statistically significant). Reoperation rates at the same level were reported as follows: at three months, three reoperations in ACD group, two in cage group; at one year, an additional reoperation in each group; at two years, an additional three in the ACD group. There were some additional procedures at adjacent levels that were equivalent for both groups over two years. In total, for the ACD group, 17/46 were investigated, seven had the same level reoperation and two had adjacent level operations. In the cage group, 15/40 were investigated with three having same level reoperation and three having adjacent level operations. There were no statistically significant differences reported in kyphosis or fusion rate.

Author conclusions (relative to question): No difference in outcome between ACD and ACDF with cage and local autograft bone. Oktenoglu T, Level III Prospective Retrospective Critique of methodology: Cosar M, Ozer Nonconsecutive patients AF, et al. Type of Study design: RCT Nonrandomized Anterior evidence: Nonmasked reviewers

cervical therapeutic Stated objective of study: Compare Nonmasked patients microdiscectom radiographic and clinical outcomes No Validated outcome measures y with or used: without fusion. Type of treatment(s): anterior cervical Small sample size J Spinal Disord decompression with fusion and plate Inadequate length of follow-up Tech. Jul (ACDFP) vs. anterior cervical <80% follow-up 2007;20(5):361- decompression (ACD) Lacked subgroup analysis 368. Diagnostic method not stated Total number of patients: 20 Other: coin flip randomization; Number of patients in relevant short duration of symptoms for subgroup(s): 11 ACD and 9 ACDF inclusion criteria

Consecutively assigned? Yes Work group conclusions: Potential level: II Duration of follow-up: 12 to 18 months, Downgraded level: III mean 14 months Conclusions relative to question: Validated outcome measures used: This paper provides evidence that:for cervical radiculopathy due to single Nonvalidated outcome measures used: level degenerative disease, ACD VAS alone provides satisfactory clinical outcomes when Compared to: ACDF Diagnosis of cervical radiculopathy made with allograft ICBG and semirigid by: plate. Radiographically, disc height is Clinical exam/history maintained significantly better with Electromyography plate and fusion although the clinical Myelogram significance is unknown. The validity MRI of the conclusions is uncertain due to CT small sample size. CT/Myelogram Other:

Results/subgroup analysis (relevant to question): Inclusion criteria required only two weeks of failed medical/interventional treatment. VAS upper extremity pain scores (dominant complaint) improved significantly in both groups, from mean 8 to 3. Although less severe initially than arm pain, VAS neck pain scores had less improvement overall, but statistically significant improvement was noted in the ACDF group. CT follow-up at one year showed disc space collapse in both groups, but significantly more in the ACD group. There was some subsidence of the graft over the first year. Final foraminal dimensions were slightly larger in ACDF group, but not significant. Reported fusion rates were 100% in the ACDF group and 45% (5/11) in the ACD group.

Author conclusions (relative to question): ACD alone provides satisfactory clinical outcomes when Compared to: ACDF with semirigid plate.

Savolainen S, Level III Prospective Retrospective Critique of methodology: Rinne J, Nonconsecutive patients Hernesniemi J. Type of Study design: RCT Nonrandomized A prospective evidence: Nonmasked reviewers randomized therapeutic Stated objective of study: Compare Nonmasked patients study of clinical results of anterior cervical No Validated outcome measures anterior single- decompression (ACD) to anterior cervical used: level cervical decompression and fusion (ACDF) with or Small sample size disc operations without plate Inadequate length of follow-up with long-term <80% follow-up follow-up: Type of treatment(s): ACD, ACDF, Lacked subgroup analysis surgical fusion ACDFP with plate for one level disease, Diagnostic method not stated is unnecessary. using autograft ICBG. Other: randomization process not Neurosurgery. specified; phone follow-up at four Jul Total number of patients: 91 years 1998;43(1):51- Number of patients in relevant 55. subgroup(s): 91; specific number in each Work group conclusions: group were not reported Potential level: II Downgraded level: III Consecutively assigned? Yes Conclusions relative to question: Duration of follow-up: 3.2 to 4.8 years, This paper provides evidence that:for mean four years patients with cervical radiculopathy due to single level degenerative Validated outcome measures used: disease, ACD yields results equivalent to ACDF with or without a Nonvalidated outcome measures used: plate. The validity of the conclusions four point scale is uncertain due to small sample size.

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other: Radiologic studies, not specified

Results/subgroup analysis (relevant to question): Follow-up data were reported for 88/91 patients. Good/excellent results were reported in 76% of ACD patients, 82% ACDF, and 73% ACDFP. Of the 88 patients, 71 had long term radiographic

follow-up, with slight kyphosis in 62% of ACD, 41% ACDF, 44% ACDFP and fusion achieved in 100% of ACDF and 90% of ACD patients. Complication rates were similar for all groups, with the exception of short term ICBG pain which was severe in 80% of both ACDF groups.

Author conclusions (relative to question): Because outcomes were similar for the three groups, ACD is recommended as procedure of choice for ease of surgery and reduced complications. Wirth FP, Dowd Level III Prospective Retrospective Critique of methodology: GC, Sanders Nonconsecutive patients HF, Wirth C. Type of Study design: RCT Nonrandomized Cervical evidence: Nonmasked reviewers discectomy. A therapeutic Stated objective of study: Compare Nonmasked patients prospective clinical outcomes of anterior cervical No Validated outcome measures analysis of discectomy (ACD), anterior cervical used: three operative discectomy with fusion ( ACDF) and Small sample size techniques. posterior cervical foraminomtomy for Inadequate length of follow-up Surgical single level HNP with radiculopathy <80% follow-up neurology; Lacked subgroup analysis 2000:340-346; Type of treatment(s): ACD, ACDF, Diagnostic method not stated discussion 346- foraminotomy Other: Poor randomization; high 348. attrition rate for long term follow-up Total number of patients: 72 Number of patients in relevant Work group conclusions: subgroup(s): 22 foraminotomy, 25 ACD, Potential level: II 25 ACDF Downgraded level: III

Consecutively assigned? Yes Conclusions relative to question: This paper provides evidence that: for Duration of follow-up: Mean 60 months single level HNP causing cervical radiculopathy, outcomes for ACD are Validated outcome measures used: equivalent to ACDF.

Nonvalidated outcome measures used: grading scheme incorporating length of hospitalization, radicular pain improvement, and return to work

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram

Other: Imaging; not specified

Results/subgroup analysis (relevant to question): In immediate postoperative results, surgical time, hospital stay and cost were slightly better for the ACD group. Postoperative pain was worse in the foraminotomy group. At two months, according to the grading scheme implemented, all three groups were about the same. Reoperations were greater at the operative site for foraminotomy and adjacent sites for ACDF patients. Long- term follow-up was accomplished via phone interview at 53 months for the foraminotomy group (14/22 patients), 56 months for the ACD group (13/25 patients) and 69 months for the ACDF group (16/25 patients), with a loss of about 40% of patients to follow-up. Within the limits of their study design and patient capture, pain improvement remained high for all groups. Return to work for was 79% for the foraminotomy group, 92% for ACD and 81% for ACDF (not statisically significant). Of the patients available at final follow-up, 100% were satisfied and would have the surgery again.

Author conclusions (relative to question): For single level HNP, all procedures are efficacious. Xie JC, Hurlbert Level II Prospective Retrospective Critique of methodology: RJ. Discectomy Nonconsecutive patients versus Study design: RCT Nonrandomized discectomy with Type of Nonmasked reviewers fusion versus evidence: Stated objective of study: Compare Nonmasked patients discectomy with therapeutic clinical and radiographic outcomes of No Validated outcome measures fusion and anterior cervical discectomy (ACD), used: instrumentation: anterior cervical discectomy with fusion Small sample size a prospective (ACDF), and anterior cervical discectomy Inadequate length of follow-up randomized with instrumented fusion (ACDFI) for <80% follow-up study. single level cervical radiculopathy Lacked subgroup analysis Neurosurgery. Diagnostic method not stated Jul Type of treatment(s): ACD, ACDF, Other: 2007;61(1):107- ACDFI; graft was autograft iliac crest 116; discussion bone graft (ICBG) Work group conclusions: 116-107. Potential level: I Total number of patients: 45 Downgraded level: II Number of patients in relevant subgroup(s): 15 ACD, 15 ADCF, 15 Conclusions relative to question:

ACDFI This paper provides evidence that:clinical outcomes for treatment of Consecutively assigned? Yes cervical radiculopathy due to single level degenerative disease are similar Duration of follow-up: two years when comparing ACD to ACDF, with or without plating. Radiographic Validated outcome measures used: outcomes were worse with ACD, McGill Pain Questionnaire (MPQ), SF-36, resulting in a significant loss of General Health Outcome Measure lordosis, although the clinical consequences of this are Nonvalidated outcome measures used: unknown.The validity of the conclusions may be compromised by Diagnosis of cervical radiculopathy made a very small sample size. by: Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other:

Results/subgroup analysis (relevant to question): Three patients in the ACD group lost to follow-up. No graft site pain was reported at two years. In general, clinical results improved to one year then plateaued. Arm pain was completely absent in 92% of ACD patients, 93% of ACDF patients and 100% of ACDFI patients. Neck pain was absent in 83%, 80% and 73%, respectively. All had significant and similar improvements in MPQ and SF-36. At two years, fusion rate on radiograph was 67%, 93%, and 100% respectively. Of patients treated with ACD, 75% had kyphosis at two years.

Author conclusions (relative to question): Patient selection is the key to surgical success. Any of these surgeries are suitable for cervical radiculopathy due to nerve root compression. Because the long term effects of kyphosis are unknown, we cannot be certain about the potential consequences of ACD.

Evidentiary Table ● Cervical Radiculopathy from Degenerative Disorders, Surgical Treatment

Does anterior cervical decompression and fusion with instrumentation result in better outcomes (clinical or radiographic) than anterior cervical decompression and fusion without instrumentation?

Article Level (Alpha by of Description of study Conclusion Author) evidence

Grob D, Peyer Level II Prospective Retrospective Critique of methodology: JV, Dvorak J. Nonconsecutive patients The use of Type of Study design: RCT Nonrandomized plate fixation in evidence: Nonmasked reviewers anterior surgery therapeutic Stated objective of study: compare clinical Nonmasked patients of the and radiographic outcomes of anterior No Validated outcome measures degenerative cervical decompression and fusion used: cervical spine: (ACDF) and anterior cervical Small sample size a comparative decompression and fusion plus plate Inadequate length of follow-up prospective (ACDFP) <80% follow-up clinical study. Lacked subgroup analysis Eur Spine J. Type of treatment(s): ACDF, ACDFP Diagnostic method not stated Oct Other: Not sure if patients were 2001;10(5):408- Total number of patients: 54, 50 available consecutively assigned. 413. for follow-up Questionable randomization Number of patients in relevant method used. subgroup(s): 50: 24 ACDFP, 26 ACDF Work group conclusions: Consecutively assigned? No Potential level: I Downgraded level: II Duration of follow-up: 22 to 46 months, average 34 months. Conclusions relative to question: This paper provides evidence that:use Validated outcome measures used: of plate in addition to anterior cervical decompression and fusion is not Nonvalidated outcome measures used: supported for the treatment of cervical Visual Analog Scale (VAS) - pain, radiculopathy from degenerative neurological exam, functional (ROM) disorders. assessment, and radiographic evidence of fusion

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI CT

CT/Myelogram Other:

Results/subgroup analysis (relevant to question): Both groups had a statistically significant decrease in VAS pain scores and improvement in cervical spine range of motion postoperatively, but there was no significant difference between groups for either of these outcome measures. Radiographically, there was no difference in the frequency of pseudoarthrosis/nonunion. The authors defined inferior “graft quality” as ventral graft dislocation greater than 2mm and/or loss of disc height by more than 2mm. Based upon these criteria, the plate group had significantly better results (p=.04).

Author conclusions (relative to question): Addition of an anterior cervical plate did not lead to an improved clinical outcome for patients treated for cervical radiculopathy with a one or two level anterior procedure. Mobbs RJ, Rao Level III Prospective Retrospective Critique of methodology: P, Chandran Nonconsecutive patients NK. Anterior Type of Study design: comparative Nonrandomized cervical evidence: Nonmasked reviewers discectomy and therapeutic Stated objective of study: compare clinical Nonmasked patients fusion: analysis and radiographic outcomes of anterior No Validated outcome measures of surgical cervical decompression and fusion used: outcome with (ACDF) vs anterior cervical Small sample size and without decompression and fusion with plate Inadequate length of follow-up plating. J Clin (ACDFP) in patients with cervical <80% follow-up Neurosci. Jul radiculopathy Lacked subgroup analysis 2007;14(7):639- Diagnostic method not stated 642. Type of treatment(s): ACDF, ACDFP Other:

Total number of patients: 242; 212 Work group conclusions: radiculopathy Potential level: III Number of patients in relevant Downgraded level: III subgroup(s): 212: 116 ACDF, 96 ACDFP Conclusions relative to question: Consecutively assigned? No This paper provides evidence that:addition of an anterior locking Duration of follow-up: one year plate may not lead to an increased Validated outcome measures used: likelihood of a satisfactory clinical outcome, but it may lower the Nonvalidated outcome measures used: likelihood of a poor outcome and Odoms criteria, radiographic fusion need for reoperation.

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other: Imaging; not specified

Results/subgroup analysis (relevant to question): Using Odom’s criteria, there was no significant difference in good to excellent outcomes between the two groups (87% of the ACDF patient group and 92% of the ACDFP). On the other hand, the noninstrumented group had a statistically significantly higher frequency of poor outcomes at 7% (8/116) Compared to: the ACDFP group at 1% (1/96. Poor outcomes were considered to be postoperative kyphosis and nonunion.

Author conclusions (relative to question): Excellent results were similar for both groups. There was a significantly higher rate of poor outcomes in the uninstrumented group and this lead to higher rate of second surgery. Zoega B, Level II Prospective Retrospective Critique of methodology: Karrholm J, Nonconsecutive patients Lind B. One- Type of Study design: RCT Nonrandomized level cervical evidence: Nonmasked reviewers spine fusion. A therapeutic Stated objective of study: to evaluate Nonmasked patients randomized whether addition of a plate to a single No Validated outcome measures study, with or level cervical fusion for DDD enhances used: without plate fusion rate and contributes to maintaining Small sample size fixation, using alignment Inadequate length of follow-up radiostereometr <80% follow-up y in 27 patients. Type of treatment(s): anterior cervical Lacked subgroup analysis Acta Orthop discectomy and fusion (ACDF), anterior Diagnostic method not stated Scand. Aug cervical discectomy and fusion plus plate Other: 1998;69(4):363- (ACDFP) 368. Work group conclusions: Total number of patients: 27 Potential level: I Number of patients in relevant Downgraded level: II subgroup(s): 15 ACDFP, 12 ACDF Conclusions relative to question: Consecutively assigned? Yes This paper provides evidence that:plate maintains alignment. Duration of follow-up: 24 months

Validated outcome measures used: radiostereometry (RSA)

Nonvalidated outcome measures used: VAS pain scale

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other:

Results/subgroup analysis (relevant to question): There was a statistically significant increase in the frequency of postoperative kyphosis in the nonplated group at one year follow-up (p=.04). At two years statistical significance was lost (p=>06). There was one nonunion in the plate group; none in the ACDF group. Clinical scores were the same for both groups.

Author conclusions (relative to question): Plate maintains alignment, but provides no advantage for healing or for clinical outcomes

Evidentiary Table ● Cervical Radiculopathy from Degenerative Disorders, Surgical Treatment

Does anterior surgery result in better outcomes (clinical or radiographic) than posterior surgery in the treatment of cervical radiculopathy from degenerative disorders?

Article Level (Alpha by of Description of study Conclusion Author) evidence

Herkowitz HN, Level III Prospective Retrospective Critique of methodology: Kurz LT, Nonconsecutive patients Overholt DP. Type of Study design: comparative Nonrandomized Surgical evidence: Nonmasked reviewers management of therapeutic Stated objective of study: compare Nonmasked patients cervical soft anterior cervical decompression and No Validated outcome measures disc herniation. fusion (ACDF) to posterior used: A comparison laminoforaminotomy (PLF) Small sample size between the Inadequate length of follow-up anterior and Type of treatment(s): ACDF, PLF <80% follow-up posterior Lacked subgroup analysis approach. Total number of patients: 44: Type II Diagnostic method not stated Spine. Oct central herniations with myelopathy Other: Improper randomization 1990;15(10):10 (n=11), Type I lateral herniations with technique -- Randomization: Type I 26-1030. radiculopathy (n=17 ACDF, n = 16 PLF) herniations alternated between Number of patients in relevant ACDF and PLF (it did not state subgroup(s): 33: 17 ACDF, 16 PLF how the randomization was completed or how allocation was Consecutively assigned? Yes concealed). It simply states "alternated" and does not state Duration of follow-up: 1.6 to 8.2 years, "randomized." Uncertain how, or if, mean 4.2 years allocation was concealed from outcome observers. Also, it was Validated outcome measures used: uncertain if follow-up was at a similar times. Nonvalidated outcome measures used: Odom's type criteria [Excellent (complete Work group conclusions: relief of pain and weakness), good Potential level: II (improvement of pain and weakness), fair, Downgraded level: III poor] Conclusions relative to question: Diagnosis of cervical radiculopathy made This paper provides evidence that: by: anterior cervical decompression with Clinical exam/history fusion and posterior Electromyography laminoforaminotomy appear equally Myelogram effective in improving pain and MRI weakness. CT CT/Myelogram

Other:

Results/subgroup analysis (relevant to question): The average age of the 17 patients assigned to the ACDF group was 43, while the average age of the 16 patients assigned to the PLF group was 39. Of the 17 ACDF patients, 94% reported good (5/17) or excellent (11/17) results. Of the 16 PLF patients, 75% reported good (6/16) or excellent (6/16) results. ACDF was not significantly better (p<0.175). Osteophytic changes were seen in 9/17 ACDF patients and 8/16 PLF patients.

Author conclusions (relative to question): Both surgical procedures are effective, but ACDF tends to be better over long term. Korinth MC, Level III Prospective Retrospective Critique of methodology: Kruger A, Nonconsecutive patients Oertel MF, Type of Study design: comparative Nonrandomized Gilsbach JM. evidence: Nonmasked reviewers Posterior therapeutic Stated objective of study: compare clinical Nonmasked patients foraminotomy results of anterior vs. posterior surgery No Validated outcome measures or anterior for cervical radiculopathy due to soft disc used: discectomy with herniation Small sample size polymethyl Inadequate length of follow-up methacrylate Type of treatment(s): anterior cervical <80% follow-up interbody decompression with fusion (ACDF) using Lacked subgroup analysis stabilization for PMMA for median or paramedian discs, Diagnostic method not stated cervical soft posterior laminoforaminotomy (PLF) for Other: Tendency for patient disc disease: posterolateral or foraminal discs selection to more lateral disc results in 292 herniations for posterior procedure, patients with Total number of patients: 363 whereas anterior for paramedian monoradiculopa Number of patients in relevant and central introduced bias. This thy. Spine. May subgroup(s): 363: 154 ACDF, 209 PLF study excluded patients with pure 15 hard discs and pure foraminal 2006;31(11):12 Consecutively assigned? No stenosis (so not consecutively 07-1214; assigned). discussion Duration of follow-up: mean 72 months, 1215-1206. minimum 30 months Work group conclusions: Potential level: III Validated outcome measures used: Downgraded level: III

Nonvalidated outcome measures used: Conclusions relative to question:This Odoms criteria paper provides evidence that:ACDF Diagnosis of cervical radiculopathy made results in statistically significantly by: better outcomes than PLF; however, Clinical exam/history ACDF is associated with a higher risk

Electromyography of complications, primarily related to Myelogram dysphagia/hoarseness. PLF is MRI associated with a higher reoperation CT rate. CT/Myelogram Other:

Results/subgroup analysis (relevant to question): Of the 363 patients included in the study, 80% (292/363: 124/154 ACDF, 168/209 PLF) were available for long term follow-up via clinical outpatient examination (14.7%), questionnaire (64.4%), and/or a telephone interview (20.9%). Complication rates, primarily related to hoarseness and dysphagia, were reported in 6.5 % of ACDF patients and 1.8% of PLF patients. Reoperation rates were reported as 2.4% for the ACDF group and 7.1% for the PLF group. Mean operating time in the ACDF group was 112 minutes 94.1 minutes for the PLF group ( p<0.000). Of the patients in the ACDF group, 93.6% (116/124) reported good (36.3%) or excellent (59.5%) results according to Odom's criteria and 0.8% reported poor results (p<0.05). Of the patients in the PLF group, 85.1% (142/168) reported good (25.6%) or excellent (59.5%) results according to Odom's criteria and 7.2% reported poor results (p<0.05). In the ACDF group, a pure soft disc was removed in 60 cases (48.4%) and a mixture of both hard and soft disc elements was removed in 64 (51.6%). In the PLF group, a pure soft disc was removed in 148 cases (88.1%) and a mixture of both hard and soft disc elements was removed in 20 (11.9%) (p<0.000). Soft disc herniations did not have significantly better outcomes than the mixture of soft and hard disc, although there appeared to be a trend. In general, shorter duration of preoperative symptoms correlated with improved outcomes.

Author conclusions (relative to question): Anterior surgery yielded statistically superior outcomes, but both were effective. The findings show a higher

success rate with anterior microdiscectomy with PMMA interbody stabilization for treatment of degenerative cervical monoradiculopathy compared with posterior foraminotomy. Wirth FP, Dowd Level III Prospective Retrospective Critique of methodology: GC, Sanders Nonconsecutive patients HF, Wirth C. Type of Study design: RCT Nonrandomized Cervical evidence: Nonmasked reviewers discectomy. A therapeutic Stated objective of study: compare clinical Nonmasked patients prospective outcomes for surgery for unilateral disc No Validated outcome measures analysis of herniation causing radiculopathy used: three operative Small sample size techniques. Type of treatment(s): anterior cervical Inadequate length of follow-up Surg Neurol. decompression (ACD), anterior cervical <80% follow-up Apr decompression with fusion (ACDF), Lacked subgroup analysis 2000;53(4):340- posterior laminoforaminotomy (PLF) Diagnostic method not stated 346; discussion Other: Functional outcome tools 346-348. Total number of patients: 72 were too broad and subjective. The Number of patients in relevant initial clinical visit occurred at two subgroup(s): 22 PLF, 25 ACD, 25 ACDF months; the 60 month follow-up was poorly coordinated and varied. Consecutively assigned? Yes Numbers were small with poor statistical analysis. Duration of follow-up: 2 months scheduled visit, mean 60 months by phone or clinic Work group conclusions: visit Potential level: II Downgraded level: III Validated outcome measures used: Conclusions relative to question: Nonvalidated outcome measures used: This paper provides evidence Satisfaction; pain; perioperative that:ACD, ACDF and PLF result in demographics; complications; scoring comparable clinical outcomes in the scale for outcomes based on return to treatment of cervical radiculopathy work, hospital stay, and pain relief from unilateral disc herniation.

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other: Imaging; not specified

stay, charges and analgesics were similar. Pain improvement was reported by more than 96% of patients in all groups. It appears that all groups had similar outcomes. Return-to-work was reported as greater than 88% in all groups. Similar incidence of new weakness and new numbness across all groups. Reoperation rate were reported as 27% for the PLF group, 12% for ACD and 28% for ACDF.

Author conclusions (relative to question): Although the numbers in this study were small, none of the procedures could be considered superior to the others. This study suggests that the selection of surgical procedure may reasonably be based on the preference of the surgeon and tailored to the individual patient.

Evidentiary Table ● Cervical Radiculopathy from Degenerative Disorders, Surgical Treatment

Does anterior cervical decompression and reconstruction with total disc replacement result in better outcomes (clinical or radiographic) than anterior cervical decompression and fusion in the treatment of cervical radiculopathy from degenerative disorders?

Article Level (Alpha by of evidence Description of study Conclusion Author) Murrey D, Level I Prospective Retrospective Critique of methodology: Janssen M, Nonconsecutive patients Delamarter R, Type of Study design: RCT Nonrandomized et al. Results of evidence: Nonmasked reviewers the prospective, therapeutic Stated objective of study: compare safety Nonmasked patients randomized, and efficacy of total disc arthroplasty No Validated outcome measures controlled (TDA) to anterior cervical decompression used: multicenter with fusion (ACDF) for single level Small sample size Food and Drug symptomatic cervical disc disease with Inadequate length of follow-up Administration radiculopathy <80% follow-up investigational Lacked subgroup analysis device Type of treatment(s): ProDisc TDA, Diagnostic method not stated exemption ACDF with allograft and plate Other: study of the ProDisc-C total Total number of patients: 209 Work group conclusions: disc Number of patients in relevant Potential level: I replacement subgroup(s): 106 ACDF, 103 TDA Downgraded level: I versus anterior discectomy and Consecutively assigned? Yes Conclusions relative to question: fusion for the This paper provides evidence treatment of 1- Duration of follow-up: 2 years with follow- that:TDA shows equivalent outcomes level up intervals at 6 weeks, 3 months, 6 to ACDF at two years for treatment of symptomatic months, 12 months and 2 years cervical radiculopathy. cervical disc disease. Spine Validated outcome measures used: J. Apr Neck Disability Index (NDI), SF-36, Visual 2009;9(4):275- Analog Scale (VAS) pain scores 286. Nonvalidated outcome measures used: Neurological exam, VAS satisfaction

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram

Other:

Results/subgroup analysis (relevant to question): There was no difference in demographics between the TDA and ACDF groups. Follow-up rates were 98% for TDA and 94% for ACDF. ACDF had statistically significantly lower smaller blood loss and operative time (although differences small). Neurological improvement was better for TDA than ACDF at six months (p<0.05), but no significant difference was seen 24 months (p=0.638). NDI improved from baseline for each group (p<0.0001); however, between groups there was a significant difference at three months for TDA (p<0.05) but not at 24 months (p=1.0000). This was also true for aggregate patients who had greater than 15 point improvement. Secondary surgical procedure were performed in 1.9% of TDA patients and 8.5% of ACDF patients. Implant revision was required in no TDA patients, but 4.7% of the ACDF patients, with 2.8% of the ACDF patients requiring supplemental fixaton. VAS neck pain, arm pain frequency and intensity was similar for TDA and ACDF patients at 24 months.

Success, as defined by greater than 20% improvement in VAS scores, was reported for 87.9% of TDA patients and 86.9% of ACDF patients at 24 months. At 24 months, 80.8% of TDA patients and 74.4% of ACDF patients had successful outcomes as assessed by the SF-36 physical component summary. The SF-36 mental component summary showed 71.8% of TDA and 68.9% of ACDF patients were successful. Patient satisfaction, narcotic use and adverse events were similar for both groups.

Author conclusions (relative to question): TDA with ProDisc is safe and effective and at least as good as ACDF. Nabhan A, Level II Prospective Retrospective Critique of methodology: Ahlhelm F, Nonconsecutive patients Shariat K, et al. Type of Study design: RCT Nonrandomized The ProDisc-C evidence: Nonmasked reviewers

prothesis - therapeutic Stated objective of study: compare Nonmasked patients Clinical and radiographic and clinical results of total No Validated outcome measures radiological disc arthroplasty (TDA) to anterior cervical used: experience 1 decompression with fusion ( ACDF) Small sample size year after Inadequate length of follow-up surgery. Spine. Type of treatment(s): ProDIsc TDA, <80% follow-up Aug ACDF with PEEK cage and plate Lacked subgroup analysis 2007;32(18):19 Diagnostic method not stated 35-1941. Total number of patients: 49 Other: They used a good Number of patients in relevant radiographic analysis tool, but chose subgroup(s): 25 TDA and 24 ACDF, all neutral and extreme extension and with radiculopathy; however, only 20 TDA lateral rotation for their motion and 21 ACDF patients could be measured analysis. Clinical evaluation was due to artifact. limited and was not their emphasis. Follow-up of only one year. Also they Consecutively assigned? Yes conclude motion was maintained with TDA; however, it was not. Range of Duration of follow-up: One year motion was decreased, but significantly greater than with ACDF. Validated outcome measures used: RSA for dynamic radiographic evaluation Work group conclusions: Potential level: I Nonvalidated outcome measures used: Downgraded level: II VAS pain score Conclusions relative to question: Diagnosis of cervical radiculopathy made This paper provides evidence by: that:compared with ACDF, patients Clinical exam/history treated with TDA have statistically Electromyography significantly greater range of motion. Myelogram Clinical outcomes are similar for both MRI groups. CT CT/Myelogram Other: Imaging; not specified

Results/subgroup analysis (relevant to question): Range of motion decreased in both groups. In the TDA group, average motion decreased from 2.3 at one week to 0.8 at 52 weeks; in ACDF, it decreased from 0.6 at one week to 0.1 at 52 weeks. Comparison between groups showed that the motion was significantly less in the ACDF group for all time points except three weeks. Preoperatively, there was no statistical difference in symptoms between both groups (P=0.1), as measured by the VAS. Both groups showed the same pattern of pain relief in arm pain at all examination times without statically significant difference (P=0.13).

The ACDF group showed a higher postsurgical resolving ratio in neck pain relief at three weeks, although without any statistically significant differences (P=0.09).

Author conclusions (relative to question): Disc motion was maintained by TDA at one year and was greater than ACDF, with similar clinical results to ACDF.

Evidentiary Table ● Cervical Radiculopathy from Degenerative Disorders, Surgical Treatment

What is the long-term result (four+ years) of surgical management of cervical radiculopathy from degenerative disorders?

Article Level (Alpha by of Description of study Conclusion Author) evidence

Hamburger C, Level IV Prospective Retrospective Critique of methodology: Festenberg FV, Nonconsecutive patients Uhl E. Ventral Type of Study design: case series Nonrandomized discectomy with evidence: Nonmasked reviewers pmma therapeutic Stated objective of study: review results of Nonmasked patients interbody fusion anterior cervical decompression (ACD) No Validated outcome measures for cervical disc with polymethylmethacralate (PMMA) used: disease: long- Small sample size term results in Type of treatment(s): ACD with PMMA Inadequate length of follow-up 249 patients. <80% follow-up Spine. Feb 1 Total number of patients: 351 Lacked subgroup analysis 2001;26(3):249- Number of patients in relevant Diagnostic method not stated 255. subgroup(s): 319:; 249/319 available for Other: final follow-up Work group conclusions: Consecutively assigned? No Potential level: IV Downgraded level: IV Duration of follow-up: 10 to 15 years, mean 12.2 years Conclusions relative to question: This paper provides evidence that:for Validated outcome measures used: the treatment of cervical radiculopathy due to single level disease, ACD with Nonvalidated outcome measures used: PMMA interbody spacer results in Odoms criteria 77% of patients reporting satisfactory clinical outcomes at 10 to 15 years Diagnosis of cervical radiculopathy made following surgery. by:

Clinical exam/history Electromyography Myelogram MRI CT CT/Myelogram Other: radiograph

Results/subgroup analysis (relevant to question): Of the 249 patients available for final follow-up, 246 had single level

and 3 had two level surgery. Good or excellent results were reported by 87% of patients. Lumbar symptoms and high occupational stress were correlated with clinical failure. Patients with soft disc herniations reported the best results. Relatively worse outcomes were reported when "patients had unclear preoperative findings."

Author conclusions (relative to question): ACD with PMMA is a safe and reliable method for treating monosegmental radiculopathy with outcomes and complication rates similar to other published studies. Heidecke V, Level IV Prospective Retrospective Critique of methodology: Rainov NG, Nonconsecutive patients Marx T, Burkert Type of Study design: case series Nonrandomized W. Outcome in evidence: Nonmasked reviewers Cloward therapeutic Stated objective of study: to review Nonmasked patients anterior fusion outcomes of Cloward type fusion No Validated outcome measures for used: degenerative Type of treatment(s): anterior cervical Small sample size cervical spinal decompression with fusion (ACDF) using Inadequate length of follow-up disease. Acta Cloward technique and iliac crest bone <80% follow-up Neurochir graft (ICBG) Lacked subgroup analysis (Wien). Diagnostic method not stated 2000;142(3):28 Total number of patients: 156 Other: 3-291. Number of patients in relevant subgroup(s): 28 patients with Work group conclusions: radiculopathy only Potential level: IV Downgraded level: IV Consecutively assigned? No Conclusions relative to question: Duration of follow-up: 4 to 10.5 years, This paper provides evidence that:for mean 6.5 years treatment of cervical radiculopathy due to degenerative disease, ACDF Validated outcome measures used: with Cloward technique results in 93% satisfactory results with long term (4- Nonvalidated outcome measures used: 10 year) follow-up. three point scale of good, fair and poor; radiographic analysis; neurological exam.

Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI CT

CT/Myelogram Other:

Results/subgroup analysis (relevant to question): Of the 28 radiculopathy patients included, long term outcome was reported as good for 93% and fair for 7%. No poor results were reported. Adverse events were dominated by graft site complications.

Author conclusions (relative to question): Cloward ACDF is a reliable and safe procedure for single level disease. Jagannathan J, Level IV Prospective Retrospective Critique of methodology: Sherman JH, Nonconsecutive patients Szabo T, Type of Study design: case series Nonrandomized Shaffrey CI, evidence: Nonmasked reviewers Jane JA. The therapeutic Stated objective of study: review results of Nonmasked patients posterior posterior foraminotomy (PLF) for No Validated outcome measures cervical treatment of single level cervical used: foraminotomy in radiculopathy Small sample size the treatment of Inadequate length of follow-up cervical Type of treatment(s): PLF <80% follow-up disc/osteophyte Lacked subgroup analysis disease: a Total number of patients: 973 Diagnostic method not stated single-surgeon Number of patients in relevant Other: experience with subgroup(s): 212 a minimum of 5 Work group conclusions: years' clinical Consecutively assigned? Yes Potential level: IV and Downgraded level: IV radiographic Duration of follow-up: 5 to 15 years, mean follow-up. J 78 months Conclusions relative to question: Neurosurg This paper provides evidence Spine. Apr Validated outcome measures used: that:posterior laminoforaminotomy for 2009;10(4):347- Neck Disability Index (NDI) the treatment of cervical radiculopathy 356. due to degenerative disease results in Nonvalidated outcome measures used: significant improvement in 93% of cases at 5-15 year follow-up. There Diagnosis of cervical radiculopathy made may be a trend for patients older than by: 60 years with initial lordosis of less Clinical exam/history than 10 degrees to be more Electromyography vulnerable to development of Myelogram postoperative cervical kyphosis or MRI translational deformity, though the CT clinical significance of this is CT/Myelogram uncertain. Other:

Results/subgroup analysis (relevant to question): Follow-up was reported for

162/212 patients. While NDI improved in 93% of patients, 20% developed kyphosis. Patients who developed kyphosis reported worse results overall. During the follow-up period, 3.1% (5/162) required additional procedures; two had progression of disease at the index level, two developed stenosis and one developed "instability."

Author conclusions (relative to question): PLF is highly successful for treating cervical radiculopathy. Wirth FP, Dowd Level III Prospective Retrospective Critique of methodology: GC, Sanders Nonconsecutive patients HF, Wirth C. Type of Study design: RCT Nonrandomized Cervical evidence: Nonmasked reviewers discectomy. A therapeutic Stated objective of study: compare clinical Nonmasked patients prospective outcomes for surgery for unilateral disc No Validated outcome measures analysis of herniation causing radiculopathy used: three operative Small sample size techniques. Type of treatment(s): anterior cervical Inadequate length of follow-up Surg Neurol. discectomy ACD), anterior cervical <80% follow-up Apr discectomy with fusion (ACDF), posterior Lacked subgroup analysis 2000;53(4):340- foraminotomy Diagnostic method not stated 346; discussion Other: Functional outcome tools 346-348. Total number of patients: 72 were too broad and subjective. The initial clinical visit occurred at two Number of patients in relevant months; the 60 month follow-up was subgroup(s): 22 PLF, 25 ACD, 25 ACDF poorly coordinated and varied. Numbers were small with poor Consecutively assigned? Yes statistical analysis. 40% lost to follow- up. Duration of follow-up: 2 months scheduled visit, mean 60 months by phone or clinic Work group conclusions: visit Potential level: II Downgraded level: III Validated outcome measures used: Conclusions relative to question: Nonvalidated outcome measures used: This paper provides evidence that:for satisfaction; pain; perioperative unilateral radiculopathy caused by demographics; complications; scoring cervical disc herniation, ACD, ACDF scale for outcomes based on return to or posterior foraminotomy result in work, hospital stay, and pain relief satisfactory outcomes at five year follow-up. Diagnosis of cervical radiculopathy made by: Clinical exam/history Electromyography Myelogram MRI

CT CT/Myelogram Other: Imaging not stated

Results/subgroup analysis (relevant to question): Age, gender and duration of symptoms were similar for all groups. Although not specifically stated, follow-up was inclusive. Anesthesia time, hospital stay, charges and analgesics were similar. Pain improvement was reported by more than 96% of patients in all groups. It appears that all groups had similar outcomes. Return-to-work was reported as greater than 88% in all groups. Similar incidence of new weakness and new numbness across all groups. Reoperation rate were reported as 27% for the PLF group, 12% for ACD and 28% for ACDF. Of the 72 patients included in the study, 60% (43/72) were available at final follow-up [13/25 (52%) for ACD, 16/25 (64%) for ACDF, and 14/22 (64%) for posterior foraminotomy].

Author conclusions (relative to question): ACD, ACDF or posterior foraminotomy are reasonable surgical choices for cervical radiculopathy due to unilateral disc herniation.

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