An Osteopathic Approach for the Concussed Athlete

AN OSTEOPATHIC APPROACH FOR THE CONCUSSED ATHLETE

ALBERT J KOZAR, DO, FAOASM, R-MSK BOARD CERTIFIED NMMOMM, FP, CAQSM, RMSK PROGRAM DIRECTOR / ASSOCIATE PROFESSOR ONMM RESIDENCY & INTEGRATED SPORTS MED / ONMM RESIDENCY EDWARD VIA COLLEGE OF OSTEOPATHIC MEDICINE

DISCLOSURES

My only disclosures are: • I am a Fighting Irish Fanatic !!! • I love Jazz !!! • really can’t stand country music OBJECTIVES ① Be able to discuss the Berlin Concussion Statement in relation to an Osteopathic Manipulative Approach ② Be able to discuss the anatomical connectivity and mobility of the cranial & spinal dura ③ Be able to discuss the newly discovered Glymphatic drainage system of the CNS and recent high quality OMT research of the lymphatic system by Lisa Hodges, PhD ④ Be able to formulate a manipulative approach to the mechanical and whiplash affects of concussion ?? ⑤ Be able to discuss the evidence in the literature ① Specific to OMT and concussions ② Specific to OMT and symptoms that occur in concussion

⑥ Be able to discuss the current active RTCs of OMT and concussion

⑦ Understand and be able to apply OMT techniques in the approach to treating concussion (Hands-On Lab) ⑧ Be able to discuss when to apply OMT in the treatment of concussions and the absolute / relative contra-indications (Hands-On Lab)

OSTEOPATHY “Do you practice decorticate or decerebrate Osteopathy ?”

Anthony Chila, DO, FAAO, FCA

OSTEOPATHY “Even heads have bodies attached to them …”

Viola Frymann, DO, FAAO, FCA CRANIAL CONCEPT

William Garner Sutherland proposed the cranial concept in 1929 “Cranial” osteopathy is a misnomer since it was originally described in the head but in reality is a whole- body concept Cranial is not a separate treatment modality but an extension of osteopathy as originally described by A. T. Still Sutherland Berlin 2016 Consensus Statement on Concussion in Sport. McCrory P, et al. Br J Sport Med 2017; 0; 1-10

DEFINITION OF SRC

“Sport related concussion is a traumatic brain injury induced by biomechanical forces. Several common features that may be utilized in clinically defining the nature of a concussive head injury include: “  SRC may be caused either by a direct blow to the head, face, neck or elsewhere on the body with an impulsive force transmitted to the head  SRC may result in neuropathological changes, but the acute clinical signs and symptoms largely reflect a functional disturbance rather than a structural injury and, as such, no abnormality is seen on standard structural neuroimaging studies Berlin 2016 Consensus Statement on Concussion in Sport. McCrory P, et al. Br J Sport Med 2017; 0; 1-10 SUSPECTED DX OF SRC CAN INCLUDE ONE OR MORE OF THE FOLLOWING …

Symptoms • Somatic (HA, nausea, dizziness, fatigue, sensitivity to light & noise) • Cognitive (feeling slowed down, feeling mentally “foggy”) • Emotional (lability, sadness, nervousness, feeling more emotional) Signs • Physical (vomiting, LOC, amnesia, neuro deficits) • Balance Impairment (gait unsteadiness) • Behavioral Changes (irritability, personality changes) • Cognitive Impairment (slowed reaction time) • Sleep Disturbances (somnolence, drowsiness, change in sleep patterns, trouble falling asleep) First organized this way with Zurich 2012 Consensus Statement on Concussion in Sport. Clin J Sport Med 2013; 23(2) Berlin 2016 Consensus Statement on Concussion in Sport. McCrory P, et al. Br J Sport Med 2017; 0; 1-10 DIAGNOSIS OF PCS

A standard definition for persistent post-concussive symptoms is needed to ensure consistency in clinical management and research outcomes ‘persistent symptoms’ …

 “following SRC should reflect failure of normal clinical recovery— that is, symptoms that persist beyond expected time frames (ie, >10–14 days in adults and >4 weeks in children)”

 “does not reflect a single pathophysiological entity, but describes a constellation of non-specific post-traumatic symptoms that may be linked to coexisting and/ or confounding factors, which do not necessarily reflect ongoing physiological injury to the brain”

Berlin 2016 Consensus Statement on Concussion in Sport. McCrory P, et al. Br J Sport Med 2017; 0; 1-10 DIAGNOSIS OF PCS

A standard definition for persistent post-concussive symptoms is needed to ensure consistency in clinical management and research outcomes ‘persistent symptoms’ …

 “detailed multimodal clinical assessment is required to identify specific primary and secondary pathologies that may be contributing to persisting post-traumatic symptoms”

 “Treatment should be individualized and target-specific medical, physical and psychosocial factors identified on assessment”

SOMATIC DYSFUNCTION

Impaired or altered function of related components of the somatic (body framework system) skeletal, arthrodial, and myofascial structures; and related vascular, lymphatic and neural elements GOAL OMT

①Primary - direct change in physiologic function • Neurologic • Vascular • Lymphatic • Optimization of body rhythms • Optimization of movement of musculoskeletal system – the primary machinery of life ②Secondary - restoration of structure

Berlin 2016 Consensus Statement on Concussion in Sport. McCrory P, et al. Br J Sport Med 2017; 0; 1-10

OMT FOR SRC & PCS

 “detailed multimodal clinical assessment is required to identify specific primary and secondary pathologies that may be contributing to persisting post- traumatic symptoms”

 “treatment should be individualized and target- specific medical, physical and psychosocial factors identified on assessment”

OMT should be individualized and target …specific areas of impaired or altered functional STRUCTURE / FUNCTION RECIPROCITY

Has moved beyond ‘simple’ muscle and bone to:

– BioTensegrity (Levin) & Mechanical-transduction Macro - system integration Micro - Individual cellular structure Nuclear - Proteonomics

– Neuromuscular Balance Systemic neuromotor integration of stability Engrams / Motor patterns

– Real Word Muscle Function (Brolinson & Gray) Ecconcentric contraction Supination / Pronation Link (Spiral Power) LETS REVIEW SOME IMAGES & FACTS ABOUT THE DURA The cranial dura mater: a review of its history, embryology, & anatomy. Adeeb N, et al. Childs Nerv Syst (2012) 28:827–837

The cranial dura mater: a review of its history, embryology, & anatomy. Adeeb N, et al. Childs Nerv Syst (2012) 28:827–837 The cranial dura mater: a review of its history, embryology, & anatomy. Adeeb N, et al. Childs Nerv Syst (2012) 28:827–837

The cranial dura mater: a review of its history, embryology, & anatomy. Adeeb N, et al. Childs Nerv Syst (2012) 28:827–837

Primal Pictures 37 WHY MIGHT CNS VENOUS SYSTEM VULNERABLE TO SOMATIC DYSFUNCTION (STASIS) ?

1. Cranial venous sinuses are carried within the dura mater 2. Lack of muscular system to promote flow – flow is dependent on primary respiratory mechanism (PRM) 3. Anatomical mechanical restrictors: 1. # obtuse & right angles to flow against current 2. Rigidity, width, & trabeculae crossings

The cranial dura mater: a review of its history, embryology, & anatomy. Adeeb N, et al. Childs Nerv Syst (2012) 28:827–837 DURAL TENSION

“When the dural membrane of the cranium is subjected to tension in a certain direction over time, the fibers within the membrane seem to organize and align themselves with the direction of tension. Study of the fiber organization patterns may disclose the direction of principal tensions to which the membranes were subjected during life.”

The cranial dura mater: a review of its history, embryology, & anatomy. Adeeb N, et al. Childs Nerv Syst (2012) 28:827–837

This would indicate that distortion of the cranial vault creates resultant tension in the cranial dura mater Dr. Alf Brieg Biomechanic of the Nervous System (1960) Precise & detailed movement in Rhesus monkeys Telescoping

DURAL MOBILITY SUMMARY

• The spinal Dura is suspended by the dentate ligaments, the brainstem by the cranial nerves • The pons-cord tract changes length by 4.5-7.5cm during dorsal extension & ventral flexion • 0.8-1.4 cm brainstem • 1.8-2.8 cervical • 0.9-1.3cm thoracic • 1-2cm in lumbosacral cord • The pons cord tract telescopes with dorsal extension • The Pons cord tract is continuous with the spinal nerve roots and peripheral nerves

SPINAL DURAL BRIDGES

1ST report of a myodural connection to the atlas (Hack, et al, Spine 1995) • a “connective tissue bridge” between the posterior atlanto-occipital membrane and the rectus capitus posterior minor muscle • observed that in all cases, extension of the head and neck produced an “infolding” of the dura mater • protect the flow of cerebrospinal fluid during head extension Dura mater is firmly attached to the 2nd and 3rd cervical vertebrae (Mitchell and Humphrey’s- JMPT 1998) Dura mater is also attached, variably, to the posterior longitudinal ligament by fibrous slips denser toward the lumbar region Most anatomy authorities tend to agree that the dura mater of the spinal cord attaches to the anterior surface of the sacral canal at the level of the 2nd sacral segment

Kourosh Kahkeshani And Peter J. Ward. Connection Between the Spinal Dura Mater and Suboccipital Musculature: Evidence for the Myodural Bridge and a Route for Its Dissection—A Review Clinical Anatomy 25:415–422 (2012) TAKE HOME PRINCIPLE “Core Link” between the Cranium & Spine Tensions that developed within the cranial dura mater may be transmitted to the spine and pelvis (AND Visa Versa) through ① the connections specifically at C1, C2, C3, the sacrum & coccyx, & ② via dural sheath to epineural connective tissue at each segmental level in the spine LETS REVIEW SOME FACTS ABOUT LYMPHATICS THE GLYMPHATIC

SYSTEM Virchow-Robin Space and Interstitial Flow • production of CSF is not only derived from the choroid plexus but also from water flux dynamics occurring at the Virchow-Robin space (VRS) • CSF interstitial flow directly drains into lymphatic channels at the base of the skull, suggesting a pathway that is equivalent to a drainage system for the clearance of waste molecules from the brain • hydrodynamic process is bidirectional in terms of communication flux and is driven, in part, by respiratory and cardiac pressure pulsations

THE GLYMPHATIC SYSTEM OMT & GLYMPHATIC The Glymphatic-Lymphatic Continuum: Opportunities for OMM. SYSTEM McCrory P, et al. JAOA March 2016 | Vol 116 | No. 3

OMT applied to the glymphatic system would have the same 4 goals as OMT applied to the lymphatic system: ① open myofascial transition areas ② maximize diaphragmatic movement, ③ augment lymphatic flow, and ④ mobilize fluid in the lymphatic- venous system

WHAT DO WE KNOW ABOUT LYMPHATICS IN OTHER PARTS OF THE BODY ? OMT & LYMPHATIC FLOW

Lisa M. Hodge, Ph.D has develop a small animal model to study the effect of LYMPHATIC PUMP TECHNIQUES (LPT) during disease Discovered that LPT protects against pneumonia by reducing the number of bacteria in the lungs of infected rats. Huff, J.B., Schander, A., Downey, H.F. and Hodge, L.M. Lymphatic Pump Treatment Enhances the Lymphatic Release of Lymphocytes. Lymphatic Research and Biology 2010; 2010; 8(4): 183-7. Creasy C, Schander A, Orlowski A, Hodge LM. Thoracic and Abdominal Lymphatic Pump Techniques Inhibit the Growth of S. pneumoniae Bacteria in the Lungs of Rats. Lymphat Res Biol 2013;11(3):183-6. Hodge LM, Creasy C, Carter K, Orlowski A, Schander A, King HH. Lymphatic pump treatment as an adjunct to antibiotics for pneumonia in a rat model. J Am Osteopath Assoc. 2015 May 1;115(5):306-16. OMT & LYMPHATIC FLOW

Treadmill exercise and Lymphatic Pump Techniques (LPT) enhanced lymphatic flow in instrumented dogs Lymphatic Pump Techniques (LPT) significantly increased the concentration of leukocytes in thoracic duct lymph in conscious dogs

Lisa M. Hodge, H.H. King, A. G. Williams, Jr., S. Reder, T.J. Belavadi, J. Simecka, S. Stoll, and H. F. Downey. Abdominal lymphatic pump treatment increases leukocyte count and flux in thoracic duct lymph. Lymphatic Research and Biology 2007; 5(2): 127-132.

OMT & LYMPHATIC FLOW

LPT significantly increased lymph flow and the lymphatic concentration of leukocytes in both dogs and rats. LPT did not preferentially mobilize any specific immune cell population But LPT significantly increased both thoracic duct lymph flow and total leukocyte concentrations, resulting in a tenfold increase in the leukocyte flux LPT also enhanced the lymphatic flux of inflammatory cytokines, chemokines and reactive oxygen and nitrogen species in both the thoracic and mesenteric lymph The mesentery was a significant source of the lymph, immune cells and inflammatory mediators that were mobilized during LPT Lisa M. Hodge, M.K. Bearden, A. Schander, J.B. Huff, A.Williams, Jr., H.H. King, H.F. Downey. Abdominal Lymphatic Pump Treatment Mobilizes Leukocytes from the Gastrointestinal Associated Lymphoid Tissue into Lymph. Lymphatic Research and Biology 2010; 8(2): 103-10. A. Schander, H.F. Downey and L.M. Hodge. Lymphatic Pump Manipulation Mobilizes Inflammatory Mediators into Lymphatic Circulation. Journal of Experimental Biology and Medicine 2012; 237(1):58- 63. Schander A, Padro D, King HH, Downey HF, Hodge LM. Lymphatic pump treatment repeatedly enhances the lymphatic and immune systems. Lymphat Res Biol. 2013 Dec;11(4):219-26. OMT & LYMPHATIC FLOW PENDING STUDIES

The purpose of this proposal to identify lymphatic pump treatment enhances efficacy of antibiotic for the treatment of pneumonia AOA 13-11-687, Hodge (Primary Investigator), 09/01/13-02/29-16. Lymphatic pump treatment as an adjunctive therapy for the treatment of pneumonia. The objective of this proposal is to determine if LPT provides protection during inflammatory bowel disease. American Academy of Osteopathy, Hodge (Primary Investigator), 04/01/14-06/30/15. Lymphatic pump technique as a treatment modality for inflammatory bowel disease. The purpose of this study is to ascertain if OMT improves low back pain symptoms in patients with Type 2 Diabetes Mellitus AOA 13-11-686, Licciardone (Primary Investigator), 09/01/13-08/31-15 . American Osteopathic Association Osteopathic Manipulative Treatment of Somatic Dysfunction and Chronic Low Back Pain in Patients with Type 2 Diabetes Mellitus OSTEOPATHIC PRINCIPLES APPLIED TO CONCUSSION CONCUSSION: OSTEOPATHIC PRINCIPLES Acute head trauma can create temporary craniosacral SD • Forces can be linear or rotational

SD in head trauma can occur in any part of the neurocranium, viscerocranium or sacrum • Dural attachments: described in prior slides

Diagnosis is made by ART: Screen, Scan, Segmental Diagnosis • Observation of Asymmetry • Palpation for position • Palpation for mobility of areas involved

Becker RE. Craniosacral Trauma in the Adult. Osteopathic Annals, 1976;5:213-25. Magoun HI. Whiplash Injury: A Greater Lesion Complex. JAOA, Feb 1964;63:524-35. CONCUSSION: OSTEOPATHIC PRINCIPLES “Most acute trauma is self-correcting because of the rhythmic forces inherent in each person”

“Any residual effect - longstanding trauma - can leave a lasting effect on the efficiency of inherent body rhythms possibly leading to acute symptom disappearance and slow functional degradation over time - days, weeks, months, years”

Becker RE. Craniosacral Trauma in the Adult. Osteopathic Annals, 1976;5:213-25. Magoun HI. Whiplash Injury: A Greater Lesion Complex. JAOA, Feb 1964;63:524-35. CRANIAL SOMATIC DYSFUNCTION AFFECTS FUNCTION Ophthalmologic • CN II, III, IV, VI Gastrointestinal • CN IX, X, XII Respiratory • CN X Musculoskeletal • CN XI Parasympathetics • CN III, VII, IX, X CONCUSSION: WHERE DO I LOOK FOR AREAS OF SOMATIC DYSFUNCTION Somatic Injury: Think: Whiplash assoc dysfunctions: • Impaired cranio-cervical flexion (OA) • Impaired lower cervical extension, mid to upper thoracic extension • 1st/2nd rib elevations • Lumbosacral compression What is autonomic innervation head ? • Sympathetic: T-L outflow T1-4, Infer & Super Cerv ganglia • Parasympathetic: 4 Ganglia: Ciliary, Pterygopalatine, Otic, & Submandibular What is somatic innervation of head ? • Somatic motor fibers of cervical nerves innervate muscles derived from cervical somites including the prevertebral (ventral rami) and postvertebral (dorsal rami) muscles, and the strap muscles (ansa cervicalis) • The cervical spinal nerve plexus formed by the ventral rami of C2, 3 & 4, innervates the anterior and lateral skin of the neck and innervate the posterior scalp and neck What is lymphatic drainage of head ? • Newly determined Glymphatic pathways What is arterial / venous flow to head ? • Why might they be vulnerable to SD ? What was direction/mechanism of impact ? • For direct cranial membranous, sutural, &/or intra-osseous restrictions • Compression of SBS is common, esp in football 5 MODELS OF Credit: Gregory Hon, DO 2015 AOASM Lecture CONCUSSION GENERAL OSTEOPATHIC OSTEOPATHIC APPROACH APPROACH TO CONCUSSION Structural Structural • Goal – optimize mobility and • Goal –Cranium, Sacrum, C/T/L Spine, biomechanics Ribs Restore tensegrity, postural/muscle imbal Respiratory/Circulatory Respiratory/Circulatory • Goal – increase respiration, increase • Goal – optimize CNS perfusion & oxygenation oxygenation, optimize CSF flow, optimize Metabolic lymphatic drainage • Goal – enhance homeostatic and self- Metabolic healing mechanisms • Goal – optimize CNS metabolism/self- Neurologic healing • Goal – enhance autonomic balance and neuronal reflex activity Neurologic Behavioral • Goal – optimize CNS fxn, ANS fxn, ENS function • Goal – improve psychological and social elements of well-being Behavioral • Goal – address psychosocial symptoms RESEARCH

RESEARCH RESEARCH

PRIOR STUDIES PRIOR RESEARCH SUMMARY

Cerritelli et al, J Pain Research, 2017 (OMT & primary headache) • RTC: Cerritelli et al. Complementary Therapies Med 2015 (migraine) • RTC: Rolle et al, JAOA 2014;114 (9):678-685 (frequent episodic tension-type headache) • RTC: Voigt et al, J Alter Comp Med, 2011 (migraine – 42 fem) • RTC: Anderson & Seniscal. J Head Face, 2006 (tension headache) • RTC: Hoyt et al, JAOA, 1979 (muscle headache)

Guillaud, Darbois, Monvoisin, & Pinsault, PLOS ONE, 2016 (Cranial OMT & …) • Efficacy Studies: (n= 14 RTCs): Raith 2016, Castro-Sanchez 2016, Haller 2015, Bialoszewski 2014, Elden 2013, Arnadottir 2013, Amrovabady 2013, Mataran-Penarrocha 2011, Sandhouse 2010, Nourbakhsh 2008, Melh-Madrona 2007, Hayden 2006, Hanten 1999 • Reliability Studies: (n= 9 RTCs): Halma 2008, Sommerfeld 2003, Moran 2001, Vivian 2000, Rogers 1998, Hanten 1998, Norton 1996, Systematic Wirth-Pattullo 1994, Upledger 1977 Reviews Franke, Franke, & Fryer, IJOM 2015 (chronic nonspecific neck pain) • RTC: Tempel et al. 2008; RTC: Schwerla, 2008; RTC: Mandara. 2010

Jakel, Hauenschild, & BA, JAOA 2011 (Cranial OMT and …) • RTC: Wyatt et al, Arch Dis Child 2011 (general health, well-being, cerebral palsy) • RTC: Sandhouse et al, JAOA. 2010 (visual function) • RTC: Hayden & Mullinger, Complement Ther Clin Pract. 2006 (crying, irritability, sleep in infantile colic) • RTC: Sergueef et al, Altern Ther Health Med. 2002 (Traube-Hering-Mayer oscillations) • RTC: Hanten et al. J Man and Manip Ther. 1999 (CV4, tension headache) • RTC crossover: Cutler et al, J Altern Comp Med 2005 (Sleep Latency & Sympathetic N activity) • RTC crossover: Nelson et al, J Manip Physiol Ther 2006 (low-frequency oscillations in cutaneous blood flow velocity) • Observational: Milnes & Moran, Int J Osteopath Med 2007 (CV4, autonomic nervous system function) OSTEOPATHIC MANIPULATIVE TREATMENT FOR CHRONIC NONSPECIFIC NECK PAIN: A SYSTEMATIC REVIEW AND META-ANALYSIS FRANKE, FRANKE, & FRYER, 2015 IJOM

• This review suggested clinically relevant effects of OMT for reducing pain in patients with chronic nonspecific neck pain • evidence is of moderate quality • larger, high-quality randomized controlled trials are required to confirm these findings PRIOR RESEARCH SUMMARY

Papa et al, J Bodywork Movt Ther 2017 (proprioceptive balance, dizzyness) Alessandro et al, JAOA, 2014 (ADD/hyperactivity disorders)

Giles et al, J Altern Comp Med, 2013 (suboccipital decompression on heart rate variability) RTCs Schwerla et al, J Altern Comp Med, 2013 (whiplash, neck pain) Wyatt et al, Arch Dis Child, 2011 (CST on general health CP patients – sleep, pain) Lopez et al, JAOA 2011 (balance in elderly) Shi et al, JAOA 2011 (cerebral tissue oxygenation) Duncan et al, JAOA 2008 (CST on general health CP patients & spasticity) Jull et al, Spine 2002 (cervicogenic headache) PRIOR RESEARCH SUMMARY

Cohort Studies Friax et al, JAOA 2013 (dizzyness) Friax M. PM R, 2010 (vertigo)

Frymann et al, JAOA, 1992 (OMT neurological development children)

Case Control Studies

Case Series Chappell, Dodge, & Dogbey, Osteo Fam Phys 2015 (concussion & CRS) Schabert & Crow, JAOA 2009 (cost, migraine)

Frymann V. JAOA. 1976 (learning difficulties in children)

Case Reports Guernsey, Leder, & Yao, JAOA 2016 (concussion) Castillo, Wolf, & Rakowsky, JAOA 2016 (concussion) McCallister et al. JAOA 2016 (severe mTBI – in level 1 trauma ward – St Barnabus, NY)

Channell, Mueller, Hahn, JAOA 2009 (concussion)

Ideas, Findings Greenman & McPartland, JAOA 1995. Frymann …..

ASSESSING THE IMMEDIATE EFFECTS OF OMT ON SPORTS RELATED CONCUSSION SYMPTOMS CRAIG CHAPPELL, DO, OUCOM

Journal Osteopathic Family Physician Retrospective analysis of the effect of OMT on concussion symptoms in athletes with sport-related concussion 26 patient charts included OMT improved each of 22 self-reported symptoms on SCAT 2 • Statistical significance in 10 symptoms – headache, pressure in head, blurred vision, sensitivity to light, feeling in a fog, don’t feel right, difficulty concentrating, fatigue/low energy, irritability, sadness • Would likely have reached statistical significance other symptoms if given more numbers – nausea/vomiting, dizziness, confusion, drowsiness There was no worsening of any symptom after OMT

RESEARCH

ACTIVE RTCS

① The safety and efficacy of osteopathic manipulation in the treatment of mTBI (mild traumatic brain injury) in U.S. service members as validated by SPECT scan: a reports of planned research. Natalie Nevins DO & Marcel Friax DO ② Cranial Osteopathic Manipulative Medicine as an adjunct Treatment for Concussion. Rosanna C Sabini DO, Northwell Health (ClinicalTrials.gov) ③ Comparing the Effect of Osteopathic Manipulative Medicine (OMM) vs Counseling in the Treatment of Concussion. Sheldon C Yao DO & Hallie Zwibel DO, New York Institute of Technology (ClinicalTrials.gov) ④ Head impact biomechanics, the clinical diagnosis of sport related concussion and the application of osteopathic structural diagnosis & treatment. Brolinson, Leslie, Rogers, Kozar, Griesemer, VCOM Objectives • To assess the safety of OMT in participants experiencing chronic mTBI • To measure response to OMT on SPECT and neurobehavioral testing Subjects – US soldiers with a diagnosis of mTBI Intervention – OMT (vs no OMT control) • 3 OMT treatments • Weeks 2, 3, 4

Rosanna C Sabini DO, Northwell Health

Study Design: Non-Randomized, Parallel Assignment, Single Group Assessment, Single Masking (Care Provider), Feb 2010 – Jan 2013 COMPARING THE EFFECT OF OSTEOPATHIC MANIPULATIVE MEDICINE (OMM) VERSUS COUNSELING IN THE TREATMENT OF CONCUSSION SHELDON C YAO DO & HALLIE ZWIBEL DO, NEW YORK INSTITUTE OF TECHNOLOGY

Primary Outcome Measure ① Change in concussive symptoms on the Post Concussion Symptom Scale [ Time Frame: 2 months ]

Eligibility Data: • Ages Eligible for Study: 14 Years and older (Child, Adult, Senior) • Sexes Eligible for Study: All Inclusion Criteria: • Concussion occurred within 8 weeks • Age greater or equal to 14 years • Complains of post-concussive symptoms with a symptom score of >10 on PCSS COMPARING THE EFFECT OF OSTEOPATHIC MANIPULATIVE MEDICINE (OMM) VERSUS COUNSELING IN THE TREATMENT OF CONCUSSION SHELDON C YAO DO & HALLIE ZWIBEL DO, NEW YORK INSTITUTE OF TECHNOLOGY

Experimental ARM: Osteopathic Manipulative Treatment Cranial Osteopathic Manipulative Medicine. The hands will be placed on the head using the "vault hold" (bilateral thumbs are off the head, index fingers on the temporal bones, middle fingers on the sphenoid bones, ring fingers on the mastoid and the 5th fingers on the occipital bone). Diagnosis and treatment of restrictions palpated on the scalp will be made using this hand position

Sheldon C Yao DO & Hallie Zwibel DO, New York Institute of Technology

Study Design: Randomized, Parallel Assignment, Single Masking (Outcomes Assessor), 40 patient goal, Nov 2015 – Dec 2019 COMPARING THE EFFECT OF OSTEOPATHIC MANIPULATIVE MEDICINE (OMM) VERSUS COUNSELING IN THE TREATMENT OF CONCUSSION SHELDON C YAO DO & HALLIE ZWIBEL DO, NEW YORK INSTITUTE OF TECHNOLOGY

Primary Outcome Measure ① SMART Balance Master balance scores pre and post intervention arm [ Time Frame: change from the pre-intervention score after the intervention, measured at each visit through study completion, an average of 1 week after the initial visit ]

OMT should show a statistically significant improvement in balance as measured by SMART Balance Master balance scores as measured by change pre and post procedure

COMPARING THE EFFECT OF OSTEOPATHIC MANIPULATIVE MEDICINE (OMM) VERSUS COUNSELING IN THE TREATMENT OF CONCUSSION SHELDON C YAO DO & HALLIE ZWIBEL DO, NEW YORK INSTITUTE OF TECHNOLOGY

Secondary Outcome Measures ① Post-concussion symptoms as measured by ImPACT [ Time Frame: measured on day 1, day 3, and day 7 post concussion ] OMT should decrease concussion symptoms as measured by subject responses on this performance test as measured by change pre and post procedure ② Post-concussion symptoms as measured by King-Devick [ Time Frame: measured on day 1, day 3, and day 7 post concussion ] OMT should decrease concussion symptoms as measured by subject responses on this performance test as measured by change pre and post procedure. ③ Post-concussion symptoms as measured by SCAT-3 [ Time Frame: measured on day 1, day 3, and day 7 post concussion ] OMT should decrease concussion symptoms as measured by subject responses on this survey as measured by change pre and post procedure. COMPARING THE EFFECT OF OSTEOPATHIC MANIPULATIVE MEDICINE (OMM) VERSUS COUNSELING IN THE TREATMENT OF CONCUSSION SHELDON C YAO DO & HALLIE ZWIBEL DO, NEW YORK INSTITUTE OF TECHNOLOGY

Other Outcome Measures ① Return to play time [ Time Frame: Up to 90 days ] Players will be tracked for eventual clearance to return to play and OMT should decrease return to play time.

Eligibility Data • Ages Eligible for Study: 18 Years to 50 Years (Adult) • Sexes Eligible for Study: All

COMPARING THE EFFECT OF OSTEOPATHIC MANIPULATIVE MEDICINE (OMM) VERSUS COUNSELING IN THE TREATMENT OF CONCUSSION SHELDON C YAO DO & HALLIE ZWIBEL DO, NEW YORK INSTITUTE OF TECHNOLOGY

Experimental ARM: Osteopathic Manipulative Treatment A board certified NMM/OMM or FP/OMM physician will perform an osteopathic structural exam and osteopathic treatment for a 30 minute session. The investigators will follow a generalized protocol for diagnosis and treatment of the head, neck, spine, rib cage, and pelvis. The following techniques will be included in the treatment protocol, OA (Occipitoatlantal) decompression, V-Spread, venous sinus drainage, balanced membranous tension (BMT), cranial lifts, CV4, and a mix of balanced ligamentous tension (BLT), muscle energy techniques, facilitated positional release, articulatory techniques (ART), high-velocity low-amplitude, and counterstrain to address any somatic dysfunctions. Active Comparator: Counseling For the control group, an investigator will complete a 30-minute counseling session with the subject. The focus of discussion will be from the CDC's "What to expect after a concussion" article. Other resources that will also be used come from the American Academy of Family Physicians (AAFP), FamilyDoctor.org, and the Brain Care Center. Each counseling session will follow the same protocol. The counseling session will provide subject with similar face-to-face time with the OMT arm.

HEAD IMPACT BIOMECHANICS, THE CLINICAL DIAGNOSIS OF SPORT RELATED CONCUSSION AND THE APPLICATION OF OSTEOPATHIC STRUCTURAL DIAGNOSIS & TREATMENT BROLINSON, LESLIE, ROGERS, KOZAR, GRIESEMER, VCOM

Prospective, Longitudinal, Observational Cohort Design – AOA Research Grant • 3 subject groups • Cohort 1: Concussed athletes • Cohort 2: “High Impact” (>98g) athletes • Previous research has demonstrated that this is the linear head acceleration threshold for increased risk of concussion • Cohort 3: Non-concussed non-impact athletes • Recruitment Goals: • Men & women, multi-sport HEAD IMPACT BIOMECHANICS, THE CLINICAL DIAGNOSIS OF SPORT RELATED CONCUSSION AND THE APPLICATION OF OSTEOPATHIC STRUCTURAL DIAGNOSIS & TREATMENT BROLINSON, LESLIE, ROGERS, KOZAR, GRIESEMER, VCOM

Aim 1: To delineates the typical osteopathic findings in concussion in both men and women • Hypothesis: ① Concussed athletes will demonstrate a pattern of somatic dysfunction that is different from high impact non-concussed active controls as well as non-impact, non-concussed controls

② Concussed athletes will demonstrate a Neuro EEG pattern that is different from high impact non-concussed active controls as well as non-impact, non- concussed controls

③ OMT will influence the Neuro EEG pattern in concussed athletes

④ OMT will not influence the Neuro EEG pattern in high impact non- concussed and non-impact non-concussed athletes

HEAD IMPACT BIOMECHANICS, THE CLINICAL DIAGNOSIS OF SPORT RELATED CONCUSSION AND THE APPLICATION OF OSTEOPATHIC STRUCTURAL DIAGNOSIS & TREATMENT BROLINSON, LESLIE, ROGERS, KOZAR, GRIESEMER, VCOM

Aim 1: To delineates the typical osteopathic findings in concussion in both men and women • multi-dimensional assessment: • standardized clinical measures • Neuro EEG parameters • performance-based testing • psychological health • osteopathic structural diagnosis

HEAD IMPACT BIOMECHANICS, THE CLINICAL DIAGNOSIS OF SPORT RELATED CONCUSSION AND THE APPLICATION OF OSTEOPATHIC STRUCTURAL DIAGNOSIS & TREATMENT BROLINSON, LESLIE, ROGERS, KOZAR, GRIESEMER, VCOM

Methods • Outcome measures • HEAD IMPACT BIOMECHANICS, THE CLINICAL DIAGNOSIS OF SPORT RELATED CONCUSSION AND THE APPLICATION OF OSTEOPATHIC STRUCTURAL DIAGNOSIS & TREATMENT BROLINSON, LESLIE, ROGERS, KOZAR, GRIESEMER, VCOM

Aim 2: Correlate head and neck impact biomechanics with osteopathic structural evaluation through instrumenting collegiate football players with helmet-mounted accelerometer arrays • A regression model will be developed from controlled laboratory impact tests to relate head acceleration measurements on the field to neck loads and moments experienced by athletes during play • Comparisons will be performed within a contact athlete cohort and between contact and non-contact cohorts • Assessment method(s): • Head Impact Telemetry (HIT) system sensors HEAD IMPACT BIOMECHANICS, THE CLINICAL DIAGNOSIS OF SPORT RELATED CONCUSSION AND THE APPLICATION OF OSTEOPATHIC STRUCTURAL DIAGNOSIS & TREATMENT BROLINSON, LESLIE, ROGERS, KOZAR, GRIESEMER, VCOM

Aim 2: Correlate head and neck impact biomechanics with osteopathic structural evaluation through instrumenting collegiate football players with helmet-mounted accelerometer arrays • Hypothesis: ① Neck loads, while not directly measured from the accelerometer arrays, can be accurately computed from measured head accelerations

② Within football subjects, concussions occurring on days without OMT (practice days) will be associated with lower head accelerations and lower neck loads than on days with pre-game OMT (game days)

③ The non-concussed contact athletes will demonstrate that higher head accelerations and greater necks loads are associated with increased somatic dysfunction compared to non-impact non- concussed controls

HEAD IMPACT BIOMECHANICS, THE CLINICAL DIAGNOSIS OF SPORT RELATED CONCUSSION AND THE APPLICATION OF OSTEOPATHIC STRUCTURAL DIAGNOSIS & TREATMENT BROLINSON, LESLIE, ROGERS, KOZAR, GRIESEMER, VCOM

Methods • Head Impact Telemetry (HIT) system sensors • Accelerometer array fits between the normal padding of football helmets • 1 of 5 Impact locations are determined from the accelerometer readings and are categorized as front (F), side (L and R), back (B), and top (T) • Minimum threshold: Any event resulting in a peak resultant linear head acceleration greater than 10g is recorded

HEAD IMPACT BIOMECHANICS, THE CLINICAL DIAGNOSIS OF SPORT RELATED CONCUSSION AND THE APPLICATION OF OSTEOPATHIC STRUCTURAL DIAGNOSIS & TREATMENT BROLINSON, LESLIE, ROGERS, KOZAR, GRIESEMER, VCOM

Methods • Full OMT evaluation and treatment for each subject • OMT (+) regions recorded • OMT is specific to individual HEAD IMPACT BIOMECHANICS, THE CLINICAL DIAGNOSIS OF SPORT RELATED CONCUSSION AND THE APPLICATION OF OSTEOPATHIC STRUCTURAL DIAGNOSIS & TREATMENT BROLINSON, LESLIE, ROGERS, KOZAR, GRIESEMER, VCOM

Methods • Neuro EEG performed before and after OMT evaluation and treatment for each subject HEAD IMPACT BIOMECHANICS, THE CLINICAL DIAGNOSIS OF SPORT RELATED CONCUSSION AND THE APPLICATION OF OSTEOPATHIC STRUCTURAL DIAGNOSIS & TREATMENT BROLINSON, LESLIE, ROGERS, KOZAR, GRIESEMER, VCOM

DEMOGRAPHICS Sport Cohort Valid Cumulative Frequeny Percent Percent Percent Frequenc Valid Cumulative y Percent Percent Percent Football 12 41.4 41.4 41.4 Valid Concussed 10 34.5 34.5 34.5 Soccer 5 17.2 17.2 58.6 Vali High impact 7 24.1 24.1 58.6 Basketball 3 10.3 10.3 69.0 d baseline

Lacrosse 3 10.3 10.3 79.3 Baseline 12 41.4 41.4 100.0 Swimming 2 6.9 6.9 86.2 Total 29 100.0 100.0 Softball 1 3.4 3.4 89.7

Sex 7 1 3.4 3.4 93.1

8 1 3.4 3.4 96.6 Cumulative Frequency Percent Valid Percent Percent 9 1 3.4 3.4 100.0

Valid Male 16 55.2 55.2 55.2 Total 29 100.0 100.0

Female 13 44.8 44.8 100.0

Total 29 100.0 100.0 CRANIAL SOMATIC DYSFUNCTION KEY FINDINGS

Comparison between sports-related concussion injuries (cohort 1) compared to baseline subjects (Cohort 1 and 2):

• Decreased Cranial Rhythmic Impulse (CRI)

• Key Suture Restrictions in concussed subjects

• Sphenosquamous Pivot

• Nasofrontal

• Zygomaticotemporal

• Occipitomastoid

• Parietomastroid

• Petrojugular (correlates with temporal paradoxical motion)

• Palatine CRI COMPARISON

AMONGST Cohort CRI Crosstabulation

COHORTS CRI

Normal Decreasd Total

Count 0 10 10 Cohor 1) Concussed % within 0.0% 100.0% 100.0% t Cohort

Count 6 1 7 2) High impact % within 85.7% 14.3% 100.0% baseline Cohort

Count 9 3 12 3) Baseline % within 75.0% 25.0% 100.0% Cohort

Count 15 14 29 Total % within 51.7% 48.3% 100.0% Cohort REGIONAL SOMATIC DYSFUNCTION KEY FINDINGS

Comparison between sports-related concussion injuries (Cohort 1) compared to baseline subjects (Cohort 1 and 2) • 90% of Cohort 1 had a pelvic and sacral somatic dysfunction • Increased prevalence of C2 and C7 somatic dysfunction • Increased prevalence of L2-L5 AIM: this study aims to assess brain cortex electrical activity (alpha band frequency) in individuals with nonspecific chronic low back pain submitted to CV4 technique Hypothesis: patients with chronic low back pain submitted to CV4 would have the peak alpha frequency (PAF) modulated and, thus, would experience physical relaxation & decreased pain Primary Outcome • blinded mean change in peak alpha participants will be recruited from the outpatient rehabilitation frequency (PAF) (EEG analysis) service of the University Hospital of Brasília Secondary Outcome from August 2015 to August 2017 • blinded mean change in pain intensity

EEG before & after each protocol section

EEG & CV4

Support: CV4 technique affects:

• both central and autonomous nervous system (Jakel & von Hausenchild 2011) • assessed by change in the blood flow (Nelson et al, 2001) • assessed by changes in the tissue oxygen saturation (Shi et al, 2011)

• brain cortex electrical activity by electroencephalography (EEG), • is a validated method to support the results (Abazol 2005, Guosheng 2013, Huneke 2013, Tiffany 2010)

• 2 crossover studies with healthy participants: • Cutler et al 2005 showed a decrease in sleep latency • Miana et al 2013 showed an increase in the absolute power of alpha frequency

The EEG exam is useful to detect changes in the central processing of pain (Jenson 2013) Marjan et al 2013 showed increased power amplitude in alpha frequency bands and a shift towards lower frequencies of the dominant peak in chronic pain patients

SUMMARY

Larger study – prospective, specific to concussion populations • Controlled trial – OMT vs non-OMT/conventional care Multi-center Further studies to evaluate specific OMT techniques Further study to elucidate optimum time course for OMT intervention

Osteopathic Manipulative Medicine (and often specifically Osteopathic in the Cranial Field) is helpful in: CNS oxygenation, CNS perfusion, HA (Migraine, Tension, Cervicogenic, non-osteopathic study), Neck pain, Dizziness (Vertigo, Cervicogenic Dizziness, non-osteopathic study), Sleep Latency (disruption?), Fatigue, Depression

Based on the evidence, it is reasonable to think OMT would be effective in the treatment of sub-acute concussion Based on the evidence, it is reasonable to think OMT would be effective in the treatment of chronic post-concussive syndrome OMT is (likely) safe in the treatment of concussion/post-concussion syndrome QUESTIONS ? Somatic Dysfunction Treatment of Concussion THERAPEUTIC EFFECT OF CRANIAL OSTEOPATHIC MANIPULATIVE MEDICINE: A SYSTEMATIC REVIEW JAKEL & HAUENSCHILD, 2011

14. Hanten WP, Olson SL, Hodson JL, et al. The effectiveness of CV-4 and resting position techniques on subjects with tension-type headaches. J Man and Manip- ulative Ther. 1999;7(2):64-70 15. Hayden C, Mullinger B. A preliminary assessment of the impact of cranial osteopathy for the relief of infantile colic. Complement Ther Clin Pract. 2006;12(2):83-90. 16. Sandhouse ME, Shechtman D, Sorkin R, et al. Effect of osteopathy in the cranial field on visual function—a pilot study. J Am Osteopath Assoc. 2010;110(4):239-243. 17. Sergueef N, Nelson KE, Glonek T. The effect of cranial manipulation on the Traube-Hering-Mayer oscillation as measured by laser-Doppler flowmetry. Altern Ther Health Med. 2002;8(6):74-76. 18. Wyatt K, Edwards V, Franck L, et al. Cranial osteopathy for children with cerebral palsy: a randomised controlled trial [published online ahead of print February 24, 2011]. Arch Dis Child. 2011;96(6):505-512. 19. Cutler MJ, Holland BS, Stupski BA, Gamber RG, Smith ML. Cranial manipulation can alter sleep latency and sympathetic nerve activity in humans: a pilot study. J Altern Complement Med. 2005;11(1):103-108. 20. Nelson KE, Sergueef N, Glonek T. The effect of an alternative medical procedure upon low-frequency oscillations in cutaneous blood flow velocity. J Manipulative Physiol Ther. 2006;29(8):626-636. 21. Milnes K, Moran RW. Physiological effects of a CV4 cranial osteopathic technique on autonomic nervous system function: a preliminary investigation. Int J Osteopath Med. 2007;10:8-17. RELIABILITY OF DIAGNOSIS AND CLINICAL EFFICACY OF CRANIAL OSTEOPATHY: A SYSTEMATIC REVIEW GUILLAUD, DARBOIS, MONVOISIN, PINSAULT DEC 2016, PLOS ONE

EFFICACY STUDIES -- RTCs

Hanten WP, Olson SL, Hodson JL, Imler VL, Knab VM, Magee JL. The Effectiveness of CV-4 and Rest- ing Position Techniques on Subjects with Tension- Type Headaches. J Man Manip Ther 1999; 7:64–70. Hayden C, Mullinger B. A preliminary assessment of the impact of cranial osteopathy for the relief of infantile colic. Complement Ther Clin Pract 2006 Mehl-Madrona L, Kligler B, Silverman S, Lynton H, Merrell W. The impact of acupuncture and craniosacral therapy interventions on clinical outcomes in adults with asthma. Explore N Y N 2007; 3:28–36 Nourbakhsh MR, Fearon FJ. The Effect of Oscillating-energy Manual Therapy on Lateral Epicondylitis: A Randomized, Placebo-control, Double-blinded Study. J Hand Ther 2008; 21:4–14. Sandhouse ME, Shechtman D, Sorkin R, Drowos JL, Caban-Martinez AJ, Patterson MM, et al. Effect of Osteopathy in the Cranial Field on Visual Function—A Pilot Study. J Am Osteopath Assoc 2010 Castro-Sanchez AM, Mataran-Peñarrocha GA, Sa nchez-Labraca N, Quesada-Rubio JM, Granero- Molina J, Moreno-Lorenzo C. A randomized controlled trial investigating the effects of craniosacral therapy on pain and heart rate variability in fibromyalgia patients. Clin Rehabil. 2011; 25:25–35. doi: 10. 1177/0269215510375909 PMID: 20702514 Matara ́ n-Peñarrocha GA, Castro-Sa ́ nchez AM, Garc ́ıa GC, Moreno-Lorenzo C, Carreño TP , Zafra MD. Influence of Craniosacral Therapy on Anxiety, Depression and Quality of Life in Patients with Fibromyal- gia. Evid-Based Complement Altern Med ECAM 2011; 2011:178769. Amrovabady Z, Pishyareh E, Esteki M, Haghgoo HA. Effect of Craniosacral Therapy on students’ symptoms of attention deficit hyperactivity disorder. Iran Rehabil J 2013; 11:41–50. Arnadottir TS, Sigurdardottir AK. Is craniosacral therapy effective for migraine? Tested with HIT-6 Questionnaire. Complement Ther Clin Pract 2013; 19:11–4. doi: 10.1016/j.ctcp.2012.09.003 PMID: 23337558 Elden H, O ̈ stgaard H-C, Glantz A, Marciniak P, Linne ́r -C, Olse ́n F . Effects of craniosacral therapy as adjunct to standard treatment for pelvic girdle pain in pregnant women: a multicenter, single blind, randomized controlled trial. Acta Obstet Gynecol Scand 2013; 92:775–82. doi: 10.1111/aogs.12096 PMID: 23369067 Białoszewski D, Bebelski M, Lewandowska M, Słupik A. Utility of Craniosacral Therapy in Treatment of Patients with Non-specific Low Back Pain. Preliminary Report. Ortop Traumatol Rehabil 2014; 16:605– 15. doi: 10.5604/15093492.1135120 PMID: 25694375 Haller H, Lauche R, Cramer H, Rampp T, Saha FJ, Ostermann T, et al. Craniosacral Therapy for the Treatment of Chronic Neck Pain: A Randomized Sham- controlled Trial. Clin J Pain 2015:1. Castro-Sa ́ nchez AM, Lara-Palomo IC, Matara ́ n-Peñarrocha GA, Saavedra-Herna ́ ndez M, Pe ́ rez-Fa ́ r- mol JM, Aguilar-Ferra ́ ndiz ME. Benefits of Craniosacral Therapy in Patients with Chronic Low Back Pain: A Randomized Controlled Trial. J Altern Complement Med. 2016. Raith W, Marschik PB, Sommer C, Maurer-Fellbaum U, Amhofer C, Avian A et al. General Movements in preterm infants undergoing craniosacral therapy: a randomised controlled pilot-trial. BMC Complement Altern Med. 2016; 16(12) OSTEOPATHIC MANIPULATIVE TREATMENT FOR CHRONIC NONSPECIFIC NECK PAIN: A SYSTEMATIC REVIEW AND META-ANALYSIS FRANKE, FRANKE, & FRYER, 2015 IJOM

3 RTCs

① Tempel R, Steffen S, Ruetz M, Schwerla F. Osteopathy as an effective treatment alternative to physical therapy for patients suffering from chronic non specific neck pain. A randomized controlled trial. Paper presented at: Seventh International Conference on Advances in Osteopathic Medicine. 2008. Florida, USA.

② Schwerla F, Bischoff A, Nurnberger A, Genter P, Guillaume JP, Resch KL. Osteopathic treatment of patients with chronic non-specific neck pain: a randomised controlled trial of efficacy. Forsch Komplementmed 2008; 15:138e45. ③ Mandara A, Ceriani A, Guzzetti G, Gulisano V, Fusaro A, Bado F. Osteopathic manipulative treatment for chronic neck pain: a randomized placebo controlled trial on the effect on pain and disability. Int J Osteopath Med 2010;13:105. THERAPEUTIC EFFECT OF CRANIAL OSTEOPATHIC MANIPULATIVE MEDICINE: A SYSTEMATIC REVIEW JAKEL & HAUENSCHILD, 2011

• RTC: Hanten et al. J Man and Manip Ther. 1999 • RTC: Hayden & Mullinger, Complement Ther Clin Pract. 2006 • RTC: Sandhouse et al, JAOA. 2010 • RTC: Sergueef et al, Altern Ther Health Med. 2002 • RTC: Wyatt et al, Arch Dis Child 2011 • RTC crossover: Cutler et al, J Altern Comp Med 2005 (Sleep Latency) • RTC crossover: Nelson et al, J Manip Physiol Ther 2006 (low-frequency oscillations in cutaneous blood flow velocity) • Observational: Milnes & Moran, Int J Osteopath Med 2007 (CV4, autonomic nervous system function) PRIOR STUDY REFERENCES

RTCs • Cerritelli F et al. Clinical effectiveness of osteopathic treatment in chronic migraine: 3-Armed randomized controlled trial. Complementary Therapies in Medicine (2015) 23, 149—156 • Rolle, G; Tremolizzo, L; Somalvico, F; Ferrarese, C; Bressan, LC: Trial of Osteopathic Manipulative Therapy for Patients With Frequent Episodic Tension-Type Headache, J Am Osteopath Assoc. 2014;114 (9):678-685 • Alessandro et al. Effect of Osteopathic Manipulative Therapy in the Attentive Performance of Children With Attention- Deficit/Hyperactivity Disorder. JAOA May 2014, Vol. 114, 374-381. • Florian Schwerla, MSc, DO, Albrecht K. Kaiser, MSc, DO, Richard Gietz, DO, and Ralf Kastner, DO. Osteopathic Treatment of Patients with Long-Term Sequelae of Whiplash Injury: Effect on Neck Pain Disability and Quality of Life. J Altern Comp Med, 19(6) 543–549, 2013 • Karen Voigt, MPH et al. Efficacy of Osteopathic Manipulative Treatment of Female Patients with Migraine: Results of a Randomized Controlled Trial. The Journal of Alternative and Complementary Medicine 17(3), p 225–230, 2011 • K. Wyatt, V. Edwards, L. Franck, et al., Cranial osteopathy for children with cerebral palsy: a randomised controlled trial, Arch. Dis. Child. 96 (6) (2011) 505–512. • Lopez D, King HH, Knebl J, Kosmopolous V, Collins D, Patterson RM. Effect of a comprehensive osteopathic manipulation treatment on balance in the elderly population. In press J Am Osteopath Assoc. 2011 • B. Duncan, S. McDonough-Means, K. Worden, et al., Effectiveness of osteopathy in the cranial field and myofascial release versus acupuncture as complementary treatment for children with spastic cerebral palsy: a pilot study, J. Am. Osteopath. Assoc. 108 (10) (2008) 559–570. • Anderson & Seniscal. A Comparison of Selected Osteopathic Treatment and Relaxation for Tension-Type Headache. The Journal of Head and Face 46(8), p 1273–1280, September 2006 • Jull et al. A Randomized Controlled Trial of Exercise and Manipulative Therapy for Cervicogenic Headache. Spine. 27(17):1835-1843, September 1, 2002

PRIOR STUDY REFERENCES

Cohort Studies • Frymann VM, Carney RE, Springall P. Effect of osteopathic medical management on neurologic development in children. J Am Osteopath Assoc. 1992;92:729-744.

Case Series • Erik Schabert, DO; William Thomas Crow, DO, FAAO. Impact of Osteopathic Manipulative Treatment on Cost of Care for Patients With Migraine Headache: A Retrospective Review of Patient Records. J Am Osteopath Assoc. 2009 Aug;109(8):403-7 • Frymann V. Learning difficulties of children viewed in the light of the osteopathic concept. JAOA. 1976;76:712-20.

PRIOR STUDY REFERENCES

Conference Presentations of Evidence base for OMT

• Kurt Heinking, DO, FAAO. Evidence Based Osteopathic Manipulative Medicine. 2017 ACOFP. • http://www.acofp.org/ACOFPIMIS/Acofporg/PDFs/ACOFP17/hando uts/FRIDAY/Fri_pm_200_Heinking,%20Kurt_OMT%20Evidence%2 0Based%20Medicine.pdf

• Hollis H King, DO, PhD, FAAO. Research on Osteopathy in the cranial Field, What we know, What we don’t know. American Academy of Osteopathy Convocation. March 18, 2011. • Available upon request

• Smartt & O’Brien. Summary of Research Findings for Osteopathic Treatment in the Cranial Field. March 2015. • http://www.brisbaneosteopathic.com.au/sites/default/files/Cranialres earch.pdf

CONCUSSION: TREATMENT PRINCIPLES

SPORT CONCUSSION ASSESSMENT TOOL — 5TH EDITION

Key points • Any athlete with suspected concussion should be REMOVED FROM PLAY, medically assessed and monitored for deterioration. No athlete diagnosed with concussion should be returned to play on the day of injury. • Concussion signs and symptoms evolve over time and it is important to consider repeat evaluation in the assessment of concussion. CONCUSSION: TREATMENT PRINCIPLES •Acute Txm Goals: •Subacute Txm Goals: • Serially evaluate with • Next day, Day 1-10 SCAT2 and regular • Assess & Treat whole body medical evaluation as • Move Fluids: usual • Assistance of the involuntary cycle of rhythmic • I do NOT do cranial fluctuation of the CSF work at the game or • Remove venous stasis in compressed head during first 1-2 hours • General patterns of membranous articular strain correction: • I may treat same • Flexion / Extension same day IF • Torsion • 1) symptoms are • Vertical improving • Side-bending rotation • 2) symptoms are mild- • Lateral moderate • Compression • 3) HA is really the only • Specific patterns of membranous articular symptom strain correction

CONTRA-INDICATIONS TO OMT IN CONCUSSION

Suspected/confirmed cerebral/intracranial hemorrhage Severe head trauma Skull fracture Suspected/confirmed cervical fracture RELIABILITY OF Reliability Studies DIAGNOSIS AND CLINICAL EFFICACY OF CRANIAL OSTEOPATHY: A SYSTEMATIC REVIEW GUILLAUD, DARBOIS, MONVOISIN, PINSAULT DEC 2016, PLOS ONE

• xxxxx RELIABILITY OF Efficacy Studies DIAGNOSIS AND CLINICAL EFFICACY OF CRANIAL OSTEOPATHY: A SYSTEMATIC REVIEW GUILLAUD, DARBOIS, MONVOISIN, PINSAULT DEC 2016, PLOS ONE

• This THERAPEUTIC EFFECT OF CRANIAL OSTEOPATHIC MANIPULATIVE MEDICINE: A SYSTEMATIC REVIEW JAKEL & HAUENSCHILD, 2011

Review – 8 studies met inclusion criteria Conclusion: Studies are heterogeneous and insufficient to draw definitive conclusions In general, cranial OMM showed positive outcomes PRIOR RESEARCH SUMMARY

Cerritelli et al, J Pain Research, 2017 (OMT & primary headache) Systematic • RTC: Cerritelli et al. Complementary Therapies Med 2015 (migraine) • RTC: Rolle et al, JAOA 2014;114 (9):678-685 (frequent episodic tension-type headache) Revews • RTC: Voigt et al, J Alter Comp Med, 2011 (migraine – 42 fem) • RTC: Anderson & Seniscal. J Head Face, 2006 (tension headache) • RTC: Hoyt et al, JAOA, 1979 (muscle headache)

Franke, Franke, & Fryer, IJOM 2015 (chronic conspecific neck pain) • RTC: Tempel et al. 2008; RTC: Schwerla, 2008; RTC: Mandara. 2010

Papa et al, J Bodywork Movt Ther 2017 (proprioceptive balance, dizzyness) Alessandro et al, JAOA, 2014 (ADD/hyperactivity disorders) Giles et al, J Altern Comp Med, 2013 (suboccipital decompression on heart rate variability) Schwerla et al, J Altern Comp Med, 2013 (whiplash, neck pain) RTCs Wyatt et al, Arch Dis Child, 2011 (CST on general health CP patients – sleep, pain) Lopez et al, JAOA 2011 (balance in elderly) Shi et al, JAOA 2011 (cerebral tissue oxygenation) Duncan et al, JAOA 2008 (CST on general health CP patients & spasticity) Jull et al, Spine 2002 (cervicogenic headache) CONCUSSION

WHAT OMT TECHNIQUE SHOULD I USE FOR CONCUSSIONS ?