Wilkinson • Injection Therapy for Axial Pain 167 Pain Physician. 2005;8:167-173, ISSN 1533-3159 A Randomized Trial

Injection Therapy for Enthesopathies Causing Axial Spine Pain and “The Failed Back Syndrome:” A Single Blinded, Randomized and Cross-Over Study

Harold A. Wilkinson, MD, PhD

Background: Enthesopathies are a patients obtained excellent to good relief of good as that achieved after their prolothera- common cause of axial pain that is amenable pain and tenderness after 80% of prolothera- py. Subsequent to this study, only four of 35 to “minimally invasive” therapy. py injections, but only 47% after anesthetics patients required additional spine surgery, Objective: To evaluate the effectiveness alone. By questionnaire, 66% reported excel- but 29 of the 35 patients requested addition- of injection therapy for enthesopathies. lent to good relief after prolotherapy vs. 34% al injections. Design: Single blinded, randomized, after anesthetics alone. Patients reported im- Conclusions: Injection therapy of pain- and cross-over study. provement in work capacity and social func- ful enthesopathies can provide signifi cant re- Methods: Thirty-fi ve patients diagnosed tioning following both types of injections, lief of axial pain and tenderness combined as having painful enthesopathies as a major but a greater reduction in focal pain inten- with functional improvement, even in “failed pain generator were studied. Of the patients sity following prolotherapy injections. The back syndrome” patients. Phenol-glycer- studied, 86% of patients had undergone pri- mean and median durations of persistent re- ol prolotherapy provides better and longer or lumbar spine surgery and all were referred lief were 2.4 and 1.75 months with prolother- lasting relief than injection with anesthetics for neurosurgical evaluation for possible sur- apy vs. 1.8 and 0.75 months with anesthetics alone. Prolotherapy provides over six months gery. Patients were injected either with anes- alone. Roughly 10% obtained greater than six of relief for some patients but generally pro- thetics alone or with anesthetics combined months of relief from either injection. In the vides relief for only a few months. However, with phenol-glycerol proliferant prolothera- crossover portion of the study, patients re- most patients described good to excellent re- py. Outcomes were analyzed both clinically ported that prolotherapy injections follow- lief, felt that the injections had been benefi - at the time of regular follow-ups, and by a se- ing initial anesthetic-only injections provid- cial, and requested additional injections for ries of multipart questionnaires. ed much better relief than that achieved after recurrent or residual focal pain. Results: Patients received a total of 86 their anesthetic-only injections, and that an- Keywords: Enthesopathies, prolother- injections, 39 with local anesthetics, and 47 esthetic-only injections following initial pro- apy, phenol/glycerol solution, spine pain, with prolotherapy. By clinical assessment lotherapy injections failed to provide relief as failed back syndrome

“Minimally invasive” approach- tion therapy. Enthesopathies are defined thesopathies. Prolotherapy aims to re- es to therapy have become a major goal in Dorland’s Medical Dictionary as “disor- duce pain in part by toughening tissues in current health care delivery. For many ders of the muscular or tendinous attach- through chemomodulation, mediated by years, osteopathic physicians have recog- ments to bone” (1) and are also referred to cytokines and multiple growth factors, to nized that painful enthesopathies can be as periosteal or fibroosseous junction trig- induce fibroblast proliferation and sec- clinically significant, major pain genera- ger points (which differ significantly from ondary deposition of collagen fibers, and tors and are a common cause of persis- muscular trigger points). An increasing in part through chemoneuromodulation tent axial or spine pain which responds number of allopathic orthopedists, in- of peripheral nociceptors (2, 8, 9, 12, 14, to “minimally invasive” office based injec- terventional pain physicians, and physiat- 17-19, 24, 34). It traces its roots to the rists are becoming aware of this entity and technique used by Hippocrates to treat its treatment (2-22). The author, a neuro- chronic shoulder subluxation through the From: Harold A. Wilkinson, MD, PhD, Wellesley surgeon, was introduced to diagnosis and insertion of red hot wires into the shoul- Hills, MA Address Correspondence: treatment of these conditions by injection der (27). It is similar in concept to the col- Harold A. Wilkinson, MD, PhD therapy several decades ago and continues lagen modulating electrothermal tech- 5 Rockridge Road to find it useful in his practice (23) despite niques that are currently being used for Wellesley Hills, MA 02481-1432 Disclaimer: There was no external funding in prepa- the scarcity of good scientific data quan- tightening damaged shoulder capsules or ration of this manuscript. titating its effectiveness and the optimal intervertebral discs (intradiscal electro- Confl ict of Interest: None formulation of the injectate. thermal techniques). Its modern day evo- Acknowledgement: Prolotherapy, or sclerotherapy, is a lution began in the 1930s with the studies Manuscript received on 11/15/2005 Revision submitted on 12/29/2004 form of injection therapy which seems of Hackett and others (25, 27), and is now Accepted for publication on 3/5/2005 to be especially suitable for treating en- widely practiced and discussed in many

Pain Physician Vol. 8, No. 2, 2005 168 Wilkinson • Injection Therapy for Axial Pain , neurosurgical, and or- Many studies of prolotherapy have ed, randomized, and crossover study com- thopedic texts (4, 5, 7, 8, 11, 16, 20, 21, 23, been published, but few of them have paring phenol-glycerol prolotherapy with 35-40). A variety of different sclerosing, been blinded and rigorously carried out injection only (Fig. 1). neuromodulating and/or hyperosmolar in a scientific fashion (4, 8, 9, 12, 14, 15, Local anesthetics were chosen as the con- solutions have been used for prolothera- 17, 18, 23, 25, 26, 31-34). This study en- trol injection because there are published py. Phenol-glycerol prolotherapy is weak- tails careful, quantitative observations by comments suggesting that injecting pain- ly hyperosmolar and probably also helps a neurosurgeon with extensive experience ful enthesopathies simply with local an- to reduce pain in tender areas through the both in the surgical management of pain esthetics can provide equally good out- deactivation of unmyelinated small “C” and in dealing with patients with “the comes (17, 18, 42). The injections in this nerve fibers (41). failed back syndrome.” It is a single blind- study were all into enthesopathies at the

Fig 1. Flow diagram for randomized trial

Pain Physician Vol. 8, No. 2, 2005 Wilkinson • Injection Therapy for Axial Pain 169 fibroosseous, periosteal interface, not into al by an Institutional Review Board was surgical operative intervention. As a ma- muscular trigger points. not required. All patients gave written in- jor component of their clinical picture, formed consent. their complaints included both axial pain METHODS Patients entered the study from a (i.e., pain in, or adjacent to, the spine) and This study was conducted at the au- larger group of patients referred to the au- localized tenderness as a major compo- thor’s private practice, and thus, approv- thor for consideration of possible neuro- nent of their clinical picture, although in addition many suffered from radicular Table 1. Patient demographics symptoms or symptoms suggesting other spinal disorders. Painful enthesopathies were further defined in this study as per- Prolotherapy Anesthesia All Patients sistent focal fibroosseous or periosteal ar- Number of Patients (1) 30 26 35 eas of marked and focal tenderness, with no underlying bony pathology, emanat- Average Age (Range) 50 (24-73) 47 (24-73) 50 (24-73) ing pain during inactivity and on motion. Male 12 (40%) 10 (38%) 14 (40%) Gender: Preliminary diagnosis was made by histo- Female 18 (60%) 16 (62%) 21 (60%) ry and palpation. Nice et al (30) demon- Enthesopathy Location: strated that specific training greatly im- proves intertester diagnostic reliability. Posterior Pelvis (2) 24 (80%) 21 (81%) 27 (77%) The diagnosis was confirmed by eliminat- Other Spinal 6 (20%) 5 (19%) 8 (23%) ing most of the tenderness and pain from Prior Back Operation 26 (87%) 23 (88%) 30 (86%) that area by anesthetic injection. Thirty-five patients were entered in (1) Most patients received more than one injection, and 21 received injections of both types the study, 14 male and 21 female (Table (2) 84% of those with prior back operations had posterior pelvic enthesopathies 1). Their ages ranged from 24 to 73 years and averaged 50 years. Thirty of the 35 pa- tients (86%) had undergone prior lumbar spine operations but still complained of severe axial pain and disability and were referred as “failed back syndrome” pa- tients. Before entering this study all pa- tients had the diagnosis of a painful en- thesopathy confirmed by at least one prior anesthetic injection at the same site (16 of the prior injections also included cortico- steroids and 25 injections included prolo- therapy). Twenty-seven of the enthesopa- thies were located at the posterior iliac crest (77%) and the other eight were lo- cated elsewhere along the spine (lumbar- 1, thoracic-6, cervical-1). Initial injections were randomized (using a table of random numbers in units of 10) between injection with anesthetics alone vs. injections with anesthetics then phenol-glycerol prolotherapy (Fig. 1). In all patients the entire tender periosteal area was initially infiltrated (Fig. 2) with 1% without epinephrine, usual- ly a 10 ml volume depending on the size of the enthesopathy, then patients were immediately tested to ensure that most if not all of the focal tenderness had been relieved. Patients randomized to the anes- thetics alone group received subsequent infiltrations in the same area with an equal volume of 0.5% bupivacaine with- Fig 2. Painful enthesopathies should be injected in the center of the area out epinephrine. Patients randomized to of maximum tenderness and in the surrounding tender area in a three the prolotherapy group received infiltra- dimensional confi guration. Maximum tenderness is usually encountered tions subsequent to the lidocaine with an at the fi broosseous junction adjacent to periosteum. equal volume of a mixture of the 0.5% bu-

Pain Physician Vol. 8, No. 2, 2005 170 Wilkinson • Injection Therapy for Axial Pain pivacaine which also contained 1% phe- received. Crossover results also were ob- prolotherapy reported excellent or good nol and 10% glycerol. (A solution con- tained when patients returned after more results from 80% of injections, and re- taining 10% phenol in anhydrous glyc- than six weeks and requested a repeat in- ported poor results from only 11% (two erol was prepared by a pharmacy; 1 ml of jection as a continuation of their partici- injections were lost to follow-up). This this solution was mixed with 9 ml of 0.5% pation in the study. These injections were difference is statistically significant (Ta- bupivacaine by the operator prior to in- again randomized, so that some patients ble 2). Excellent or good benefit follow- jection.) Immediately following injection received a repeat of the same injection and ing injection of anesthetics alone lasted a all patients were questioned about the de- others received the alternate solution. mean of 1.8 months with a median dura- gree of relief of pain achieved, spontane- An assessment of clinical results was tion of only 0.75 months. Three patients ously and on motion. Injection was con- made by examining and questioning pa- (8%) were still enjoying excellent or good sidered adequate if nearly all of the local tients at the time of their regularly sched- relief when last seen eight to 12 months tenderness and most of the spontaneous uled follow-up office visits. In addition after their anesthetic injections, and four pain from that area had been eliminated. patients were given written report forms. patients (10%) enjoyed sustained relief of The degree of benefit provided by An initial questionnaire was filled out greater than six months. Patients inject- each injection was characterized as “Ex- by patients prior to receiving their first ed with prolotherapy reported a statisti- cellent,” “Good,” “Partial,” or “Poor,” blinded injection and before each sub- cally significantly greater mean duration based on reduction of pain and tender- sequent blinded injection. Patients were of excellent or good results (2.4 months) ness at the injected site. Patients report- asked to mail in post injection forms one with a median duration of 1.75 months. ing “Excellent” or “Good” relief of pain week after their injection and then each Five patients (11%) were still enjoying ex- reported a reduction in analog pain month following the injection. Each re- cellent or good relief when last seen three scores (scale 0-10) to 3 or less at the in- port form contained questions regard- to 12 months after their prolotherapy in- jected site. Since painful and tender en- ing the current status of: (A) the severi- jections. Only five patients (11%) were thesopathies are encountered in patients ty of both their pain and their tenderness known to be still enjoying excellent or with other pain generating abnormali- (on a 0-10 analog pain scale) at the inject- good relief more than six months follow- ties, patients in whom the enthesopathy ed site and their overall pain burden; (B) ing injection − nearly the same percentage was found to be their chief pain genera- their medication usage; (C) their activities as those injected with anesthetics alone. tor were designated as having achieved of daily living; (D) their ability to work or There were no significant complications. “Excellent” outcomes, while those with to carry out their normal routine; (E) the A quantification of benefit obtained persistent pain or disability from oth- severity of impairment of their social ac- from each of the two types of injections er causes (but with good relief at the in- tivities which they ascribed to their enthe- based on patients’ self report by question- jected site) were designated as having sopathy and also to their overall pain bur- naire differs somewhat from the clinical achieved “Good” outcomes. Patients who den; and (F) how beneficial they felt their assessment of benefit. (Possible variables reported “Partial relief” continued to re- injection had been to them. responsible for the difference include the port analog pain scores of 4-6 at the in- Statistical significance was deter- variable intervals between injections and jected site, but nonetheless felt that the mined by calculating P values using the clinical evaluations versus the fixed inter- injection had been beneficial to them. Wilcoxon Rank Sum Test. vals between injections and reports, and Most of them requested repeat injections also that a number of patient reports were when the focal pain and tenderness per- RESULTS incomplete.) Patients reported that injec- sisted or again became more severe. Pa- Thirty-five patients received a total tion with anesthetics alone provided ex- tients who reported “Poor relief” ob- of 86 injections, 39 with local anesthet- cellent or good results in only 34% of in- tained no useful relief of pain subjective- ics alone and 47 with prolotherapy. This jections but poor results in 21% − with a ly or objectivity, so that they did not re- included 17 alternate injections which greater number reporting partial relief quest, or declined, repeat injections. The were given at the patients’ request be- (45%). In contrast, those injected with duration of relief obtained was defined cause of a perceived lack of benefit from prolotherapy reported excellent or good either as the maximum duration of relief the first injection. Twelve alternate injec- results from 66% of injections, and re- until the time of pain recurrence or the tions were given after a first injection with markably only 6% reported poor results. longest time of follow-up during which anesthetics alone and five were given af- This is again statistically significant (Ta- relief was maintained, thus underesti- ter a first injection which included prolo- ble 2). mating the actual duration of relief for therapy. This accounts for the larger num- An analysis of questionnaires which some patients. ber of prolotherapy injections and also is patients completed showed that the base- Crossover results were obtained in an indication of the better results achieved line status of patients was quite similar one of two ways (Fig. 1). Patients who felt with prolotherapy injections than with in- for both injection groups (Table 3). Pa- that they had not obtained adequate re- jections of anesthetics alone. tients reported a statistically significant lief of pain and tenderness within seven Based on clinical assessment, pa- improvement in work capacity and social to 14 days following injection were giv- tients who were injected with anesthet- activities following both injections, with a en the option to request a blinded sec- ics alone reported excellent or good re- greater reduction in focal pain intensity ond injection of “the other solution.” sults from 47% of injections and poor re- following prolotherapy injection as com- They were told only that the second in- sults from 45% (one patient was lost to pared to injection of anesthetics alone. jection was “the other solution” and not follow-up after one of his injections). In Many patients continued to require med- the blinded solution which they had first contrast, patients who were injected with ications and to suffer functional impair-

Pain Physician Vol. 8, No. 2, 2005 Wilkinson • Injection Therapy for Axial Pain 171

Table 2. Assessments of benefi t from injections Prolotherapy Anesthetic aloneComparison tional spine surgery. After the conclusion Number or Number of this study only four patients required P Value (1) Mean ± SD Mean ± SD repeat surgical intervention. However, 29 Clinical Assessment of the 35 patients subsequently request- ed additional trigger point injections for Number of injections with: Good/Excellent benefi t 36 of 45 (80%) 18 of 38 (47%) NA residual or recurrent axial spine pain and Poor benefi t 5 of 45 (11%) 17 of 38 (45%) NA tenderness. Degree of benefi t (2) 2.3 ± 1.0 1.3 ± 1.3 0.0001 DISCUSSION Duration of benefi t (mos.) 2.4 ± 2.8 1.8 ±3.1 0.01 Some skepticism has been expressed Patient Reported (3) in the literature regarding the clinical sig- Number of injections with: nificance and the effectiveness and appro- Good/Excellent benefi t 23 of 35 (66%) 10 of 29 (34%) NA priateness of prolotherapy (6, 43, 44). For- Poor benefi t 2 of 35 (6%) 6 of 29 (21%) NA mer United States Surgeon General C. Ev- Degree of benefi t 2.6 ± 1.1 1.8 ± 1.2 0.005 erett Koop explains this reluctance to ac- (1) Wilcoxon rank sum test (2) Scale: 0 - 3, with 3 = excellent benefi t, cept prolotherapy of myofascial pain as (3) Not all patient reports were complete follows: “Medical folks are skeptical, and prolotherapy, unless they have tried it and ment due to other painful, or functional- apy injections (initial injection and sub- proven its worth, seems to be too easy a ly limiting, components of their complex sequent injection) was significantly bet- solution to a series of complicated prob- problems. ter statistically than the results reported lems that afflict the human body and have Thirty-five pairs of injections were from anesthetic injections (benefit scores been notoriously difficult to treat by any available for analysis in the crossover por- = 2.3 and 2.5 for prolotherapy vs. benefit other method (44).” tion of the study (Table 4). More patients scores = 1.1 and 1.5 for anesthetics alone). Painful enthesopathies differ sig- received prolotherapy injections follow- Results from anesthetic injections subse- nificantly from muscular trigger points ing initial anesthetic injection because 12 quent to an initial prolotherapy injection both in anatomic location and pathology, patients requested an alternate injection were much inferior to those achieved af- though little histologic evidence is avail- for perceived failure to obtain satisfactory ter the prolotherapy injection (change in able for either condition (21, 23, 31, 33, relief following initial injection with an- average benefit score = -0.8). In contrast 37, 45). Both occur commonly in situa- esthetics only. Only five patients request- results from prolotherapy injections sub- tions of muscular weakness and ligamen- ed an alternate injection following initial sequent to an initial anesthetic injection tous laxity, especially when muscle ten- injection with prolotherapy. Prolotherapy were strikingly and significantly more sion is heightened by anxiety or depres- subsequent to an initial prolotherapy in- beneficial statistically (improvement in sion, but both can develop in otherwise jection, and anesthetics alone subsequent average benefit score = +1.4). healthy individuals following extreme or to an initial anesthetic injection, both As noted earlier, 30 of the 35 patients unexpected effort. Many patients develop provided slightly better, but not statisti- had been referred because of continu- painful enthesopathies while recovering cally significant, cumulative benefit (us- ing pain and disability despite prior lum- from lumbar disc disease and spinal sur- ing a scale of 0 to 3, with 3 representing bar spine surgery; they were referred as gery when they resume physical exertion excellent benefit). The benefit reported to “failed back syndrome” patients for neu- after prolonged periods of inactivity. have resulted from each set of prolother- rosurgical evaluation and possible addi- Repeated injections of corticoste-

Table 3: Data submitted by patients in written reports (by injection type before and after each injection)

Status Before Maximum Benefi t Comparative P values (Wilcoxon) Injection Post Injection Comparison of Change in Values Scale Anesthesia Prolotherapy Anesthesia Prolotherapy Baseline Values Post Injection “[A1]” “[P1]” “[A2]” “[P2]” A1 vs P1 A2 vs P2 A1 vs A2 P1 vs P2 Focal site pain 0 - 10 8.5 ± 1.4 7.9 ± 1.5 6.2 ± 2.6 5.8± 2.3 NS NS 0.0002 2x10-5 intensity (1) Medication intake (2) 0 - 2 1.8 ± 0.6 1.7 ± 0.6 1.5 ± 0..6 1.7 ± 0.5 NS NS NS NS Impairment activities 0 - 21 10.4 ± 2.9 10.0 ± 2.8 9.2 ± 3.0 9.4 ± 2.9 NS NS NS NS of daily living (3) Impairment work 0 - 4 3.3 ± 0.9 3.0 ± 0.8 2.4 ± 1.0 2.5 ± 1.1 NS NS 0.0003 0.03 capacity (4) Impairment social 0 - 4 2.8 ± 0.9 2.7 ± 1.0 2.1 ± 1.1 1.9 ± 1.2 NS NS 0.004 0.002 activities (5) Values are Means ± SD (1) Analog score for pain and tenderness, 10 = most severe; (2) 0 = No medication, 1 = non-narcotic anodynes &/or NSAID’s, 2 = narcotics (3) 0 = Normal, 21 = maximally impaired; (4) 0 = Normal, 4 = maximally impaired (5) 0 = Normal, 4 = maximally impaired

Pain Physician Vol. 8, No. 2, 2005 172 Wilkinson • Injection Therapy for Axial Pain

Table 4. Cross-over study of comparative benefi t spine: Differential diagnosis and non-sur- gical treatment. In Frymoyer JW (ed). The (Mean± SD) (P Values- Wilcoxon Rank Sum Test) Adult Spine: Principles and Practice. Ra- ven Press, New York, 1991, pp 1581-1605.

Given Given Benefi t From Same Agent Given Second 8. Dorman T. Diagnosis and Injection Tech- First Second Agent Repeated Compared With First niques in Orthopedic Medicine. Williams and Wilkins, Baltimore, 1991. Anesthetic 1.1 ± 1.2 1.5 ± 1.3 NS + 4 x 10-5 9. Dorman T. Treatment for spinal pain aris- [A1] [A2] [A1 vs A2] [A1 then P2] ing in ligaments using prolotherapy: A ret- rospective study. J Orthop Med 1991; 13: Prolotherapy 2.3 ± 1.0 2.5 ± 0.9 NS - 0.004 13-19. 10. Fast A. Low back disorders: conservative [P1] [P2] [P1 vs P2] [P1 then A2] management. Arch Phys Med Rehabil (1) Scale: 0 - 3, with 3 = greatest benefi t 1988; 59:880-891. 11. Finneson BE. . 2nd Ed. JB Lip- pincott Company, Philadelphia, 1980, pp roids into a focal area can cause tissue pain persists or develops despite prior 99-100. weakness (24, 27). In contrast, one advan- spine surgery. Phenol-glycerol prolother- 12. Garvey TA, Mark MR, Wiesel SW. A pro- tage of prolotherapy is its apparent cumu- apy provides better and longer lasting re- spective, randomized, double-blind evalu- lative benefit following repeated adminis- lief than injection with anesthetics alone. ation of trigger-point injection therapy for low back pain. Spine 1989; 14:962-964. tration. Prolotherapy provides sustained Some patients obtained long-lasting relief, 13. Haldeman S, Phillips RB. Spinal manipu- pain relief in part by producing tissue but improvement generally lasted for only lative therapy in the management of low toughening through initiating fibroblast a few months; nonetheless the majority of back pain. In Frymoyer JW (ed). The Adult and collagen proliferation, which is im- patients graded their relief as “excellent” Spine: Principles and Practice. Raven proved by repeated injections (2, 8, 9, 12, or “good,” reported that the injections had Press, New York, 1991, pp 1581-1605. 14, 17, 18, 23-29, 31, 34) and also by rel- been beneficial to them, and requested ad- 14. Hauser RA. Prolo Your Pain Away. Beulah atively long-lasting inactivation of small ditional injections after they left the study, Land Press, Oak Point, IL, 1998. nerve C fiber transmission produced by if focal symptoms persisted or recurred. 15. Ingber RS. Iliopsoas myofascial dysfunc- hyperosmotic solutions or by phenol and tion: A treatable cause of “failed” low AUTHOR AFFILIATION: back syndrome. Arch Phys Med Rehabil glycerol included in the prolotherapy so- 1989; 70:382-386. lution (41). Although other studies have 16. Kahanovitz N. Diagnosis and Treatment shown that repeated injections of prolo- of Low Back Pain. Raven Press, New York, therapy can provide cumulative benefit, 1991, pp 70-74. this study did not specifically address that Harold A. 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Pain Physician Vol. 8, No. 2, 2005