The Effectiveness of Osteopathic Manipulative Medicine in the Management of Headaches Associated With Post Concussion Syndrome
Phase: EARLY_PHASE1
Conditions: Headache, Post-Concussion Syndrome
Sponsor: Hackensack Meridian Health

 
 
 
 
Protocol and Statistical Analysis Plan 
 
Study Title: The Usefulness of Osteopathic Manipulative Medicine in the Management 
of Headaches  with Post Concussion Syndrome  
 
Document Date: January 11, 2019 
 
NCT number: 04732338 
Study Team: Christine Greiss, DO, Kyle Weiss DO, Alphonsa Thomas, DO,  and Dmitry 
Esterov, DO, and Ekua Gilbert-Baffoe, MD  
 
 

Protocol (last update on January 11, 2019) 
A concussion, or mild traumatic brain injury (i.e. mTBI) is a complex  
pathophysiologic process that is caused by traumatic biomechanical forces to the head  [1]. 
There are an estimated 1.6–3.8 million sport-related concussions every year in the  United 
States [2]. However, this likely underestimates the true incidence, as there are  many mild 
traumatic brain injuries that go unreported or unrecognized [3]. The term  concussion is 
synonymous with mild traumatic brain injury, however the term concussion  may be used 
to describe instances where the individual experiences transient alteration in  mental status, 
such as from a sports related head injury, whereas a mild TBI is used in the  general medical 
context [4]. A mTBI is defined as an injury with Glasgow Coma Scale of  13–15 with loss 
of consciousness less than 30 min and post - traumatic amnesia less than  24 hrs. Overall, 
terms such as concussion, mild head injury, and mild TBI are often used  interchangeably 
to describe the physical injury itself as well as its immediate and later  symptomatic 
consequences [5].   
Mild TBI results in a constellation of physical, cognitive, vision, emotional and  
sleep-related disturbances. Signs and symptoms are broad and include headache,  dizziness, 
gait disturbance, nausea, vomiting, photophobia, trouble focusing, and fatigue.  Symptoms 
may last from several minutes to days, weeks, months or even longer in some  cases [6,7]. 
Headache is the most common physical complain after traumatic brain injury  (i.e. TBI) and 
historically is more common in patients with mTBI, with incidence ranging  from 30-90% 
[8]. Current treatment of those with mTBI has been physical and cognitive  rest, as about 
80-85% of patients with a concussion will recover to their neurological  baseline within 1-
2 weeks with this treatment [2]. Similarly, it is believed that most  patients with Post 
Traumatic Headaches (PTH) recover within a few weeks. However,  studies have shown 
15-42% of patients reporting PTH at 3 months, and 36% at 6 months  [8].   
Patients who do not recover after three months after a mTBI are categorized as  
having post concussive syndrome (PCS), which affects approximately 15% of patients  
[6,7]. A longitudinal study assessing 285 patients with PCS found that 27% of the  
population studied eventually recovered and 67% of those who recovered did so within  the 
first year [8]. In this study, no patient recovered who had PCS lasting 3 years or  longer. 
Symptoms included persistent headaches and depression. Guidelines for  management of 
PCS have not been completely established, and patients are generally  recommended to 
continue physical and cognitive rest.  
Osteopathic Manipulative Therapy (OMT) is a nonpharmacological, noninvasive  
form of manual medicine. Osteopathic practitioners use a wide variety of therapeutic  
manual techniques to improve physiological function and help restore homeostasis in the  
body. There is a structural assessment is to identify possible abnormalities of tissue  texture. 
Areas of asymmetry and misalignment of bony landmarks are also evaluated,  along with 
the quality of motion, balance, and organization. These asymmetries, also  known as 
somatic dysfunctions, are then treated by a variety of manual treatments,  administered by 
osteopaths [10].   
There has been research showing the effectiveness of OMT in the treatment of  
various types of headaches. A recent systematic review assessed 6 studies with various  

types of headaches including tension-type headaches, migraine headache, all which  showed 
statistically significant changes in various outcome measures. Outcome measures  included 
the Headache Impact Test (HIT-6) score, headache pain intensity / frequency,  and HRQoL 
[10]. A randomized control trial studied 62 patients with tension-type  headaches, and 
showed that manual therapy techniques to the suboccipital region offered  a positive 
improvement in some aspects of the patient’s quality of life [11]. Another  systematic 
review assessing migraine type headaches showed a preliminary low level of  evidence that 
OMT is effective in the management of headache [12]. Overall, studies  concluded that 
more rigorous designs and methodology are needed to strengthen the  evidence that OMT 
has benefit in headache management.   
Less has been studied regarding OMT in the treatment of symptoms related to  
concussion and post traumatic headaches. In our review of the literature, three case  reports 
were found of OMT in the treatment of concussion symptoms. One case assessed  a 16 year 
old female who had a chief complaint of headaches, and had significant  improvement of 
overall symptoms after treatment [13]. Another case report examined a  27 year old man 
with vestibular symptoms, who had symptomatic improvement after  OMT [14]. A third 
case described OMT to a 50 year old female with mTBI, and showed  improvements in 
HIT-6 scale [15].  
In the review of literature, we did not find any studies specifically looking at  
headaches related to post concussive syndrome. However, as shown above, such  headaches 
can persist for a significant amount of time and adversely affect patient’s  quality of life. 
With this study, we seek to study the effect of OMT on this population.  The techniques that 
will be utilized in our study are described below:  
1. Cervical muscle energy using postisometric relaxation - Muscle energy is a form  of 
OMT that engages the patient to voluntarily use targeted muscles on request.  After 
physical assessment of the patient’s neck and paraspinals, the physician will  place 
him/her into a precisely controlled position in a direction towards the tight  or 
restricted soft tissue barrier. The physician will then instruct the patient to  contract 
equally against the offered counterforce by the physician. This is an  isometric 
contraction where the distance between the origin and insertion of the  muscle 
remains the same. As the muscle contracts there will be a stretch of  internal 
connective tissues. Golgi tendon organs will sense this change in tension  and cause 
a reflex relaxation of the muscle fibers; similar to a negative feedback  loop. This 
reflex relaxation of the muscle will then allow the physician to  passively stretch the 
patient’s previously tightened muscle into an improved range  of motion in all planes 
of motion. This process will require isometric contraction  
for 3-5 seconds, then relax, and repeat for a total of 3 repetitions. Overall  objective 
is to stretch tightened muscles of the neck and improve range of motion  and pain 
tolerance.   
2. Myofascial Release of cervical paraspinals - Myo (muscle) and fascia (fascial,  
connective tissue) release involves a similar approach to muscle energy, in that,  the 
objective is to engage restrictive barriers. However, the treatment is more  
superficial directed toward fascial tissues that encompass and compartmentalize  all 
structures of the body. Fascia is normally a flexible and pliable tissue, but  under 
physical trauma or stress the fascia may become tight and restrictive. Steps  of the 
myofascial release will include the physician palpating the patient’s neck to  identify 

an area of restriction. Restrictive barrier will be identified as muscle  tension, 
tenderness or decreased movement of tissue. Once identified, the  physician will 
then move myofascial tissues toward a restrictive barrier, directly  applying a 
traction along the long axis of the muscle being engaged. He will then  add 
transverse forces (clockwise or counterclockwise) towards the restrictive  barriers. 
The patient will be asked to provide slow deep breaths to enhance a  relaxation and 
release of these tight tissues. The physician will then await a  “release”. This is a 
palpatory finding that requires a skilled practitioner to assess.  It will consist of a 
feeling that the previously noted tight tissues release in  pressure, or “melt away”. 
This may take several attempts. The goal of this  approach is to restore functional 
balance to all integrative tissues in the  musculoskeletal system, improve range of 
motion, pain tolerance and improve  lymphatic flow by removing myofascial 
restrictions.   
3. Sub-occipital Release - Sub-occipital release is a more focused form of  myofascial 
release that engages the sub-occipital muscles. This technique focuses  on releasing 
the fascia surrounding the sub-occipital muscles that attach to the C1- C2 vertebrae 
of the neck. With the patient laying on their back, the physician will  place his/her 
hands just below the occiput or base of the skull. The physician will  then cradle the 
occiput and apply gentle finger pressure using only the fingertips  up into the sub-
occipital space. This gentle pressure will be continued until tissue  starts to soften 
and release; approximately 30 seconds to one minute of pressure.  As the tissue 
softens, the head will extend back and rest in the physicians palms.  The goal of this 
technique will be to improve pain, stiffness and headaches. [16]  
Potential participants, after signing an informed consent, will be identified based on the  
following criteria:  
● Sustained a concussive injury at least 3 months ago  
● The injury did not involve any diagnosed bleeding within the brain 
● You did not lose consciousness for longer than 30 minutes  
● You have no history of severe migraine headaches prior to the injury 
● Were 18 years of age or older at the time of the injury  
● Are currently receiving treatment as an outpatient with Dr. Christine Greiss 
● You are not currently receiving IV infusions of medications from a headache  
specialist at the time of treatment  
● You do not have a history of rheumatoid arthritis  
The research protocol will be designed in the following way:  
1. A goal of 15 patients are to be enrolled in the study as well as an equal number of  15 
control subjects who will not participate in osteopathic treatments. The  selected 
patients will be seen for a total of three visits of which the first two  sessions will be 
treatment visits. All visits will be in 4 week intervals.   
2. Patients selected to participate in the study will undergo a musculoskeletal  
examination of the cervical spine. Testing will be comprised of :  

a. Range of motion testing involving cervical rotation, lateral side bending,  
flexion and extension.  
b. Muscular palpation of the cervical paraspinals for hypertonicity of the  
muscles and/or tenderness.   
3. The patient will then be placed supine on the examination table after which  
treatment will commence.   
4. Treatment sessions will last for 5-10 minutes each and will be performed by one  
osteopathic physician. In the time allotted, three OMT techniques will be  
performed: cervical muscle energy, myofascial release of the cervical paraspinals  
and a suboccipital release. The three physicians will have met prior to treatment to  
standardize protocol.  
5. Patients will be asked to complete the Headache Impact Test (HIT-6) at visit 1  and 
2 between about 6 weeks. All patients will also quantify their pain using a  pain 
scale before and after treatment.   
6. Change scores between pain scales between treatments will be assessed, and  
improvements between HIT-6 scores will be analyzed for statistical significance.  
Recruitment and Informed Consent  
Participants will be recruited from individuals who are being evaluated by Dr. Christine  
Greiss for Post Concussive Symptoms.   
Written informed consent will be obtained from all enrolled participants accordance with  
Institutional Review Board (IRB) policies. Potential participants will be informed that  there 
is no penalty for refusal to participate. A quiet private space will be available for the  consent 
process and there will be no time limits. Dr. Christine Greiss, the attending  physician, as 
well as the residents participating in the study will be available to answer  any questions or 
concerns that may arise.  
Consent will be in a language that is easily understood by most individuals with at least a  
6th grade education and each participant/proxy/informant will have a checklist to follow  to 
ensure they understand study procedures. All participants will be informed that the  purpose 
of the study is to help the participants pain and headaches, and will be informed  regarding 
the resident education component of the study.Time and effort commitments  
required for study participation will be explained. Verbal feedback will be solicited from  
potential participants about their understanding of the study, its risks, and potential  benefits 
prior to completion of the written informed consent form. Each potential study  participant 
will be asked to state in his/her own words what the purpose of the study is,  what he/she is 
expected to do, and what the risks and benefits are.   
All potential participants (or designated family member/legal guardian) will be given a  
copy of the written consent form. Prior to signing the consent documents, all potential  
participants will be given the opportunity to review the consent document, discuss it with  
whomever they choose (including the study investigators), and take as much time as they  
need to consider the information that has been presented to them in order to make an  
informed decision.   

Potential Risks  
There are no anticipated physical or medical risks associated with participation in the  study. 
There will be no high velocity or high impact techniques that would cause any  harm. There 
may involve some temporary discomfort during the procedure and  worsening of headache 
and neck pain. There is very little risk of any foreseeable  psychological, social, legal, or 
financial risks or harms that might result from  participating in this research study. There is 
very little risk of any orthopedic or  musculoskeletal injuries that would result from the 
treatment.   
Protection Against Risks  
All treatment will be conducted by osteopathic physicians (Doctors of Osteopathy i.e.  
DO), and residents will be supervised under the attending physician Christine Greiss,  DO.   
Participants will be informed at the time of consent that they will be offered treatment by  
JFK Medical Center in the event of a medical emergency, although the costs of this  
treatment will not be included as part of the research. Participants will be informed that  
they can withdraw their consent to participate at any time during the study without any  
consequences to them and their access to medical services.  
Confidential information will be protected by separating identifying material from data  
files and securing files in locked cabinets and/or password protected encrypted electronic  
files. JFK-JRI has internal security measures to further protect digital data, including  
identifying medical and clinical data, as per HIPAA requirements. Participants (or  proxies) 
will be informed that identifying records may be inspected by the sponsoring  agency or 
by the IRB and, therefore, absolute confidentiality cannot be assured.  
Importance of the Knowledge to be Gained  
We anticipate that the information gathered will make a significant contribution to  the 
knowledge and understanding of the treatment of headaches with OMT. We hope that  the 
treatment will improve symptomatology. We hope to provide an educational  
component to the other Physical Medicine and Rehabilitation residents in the program as  
well to increase the awareness and use of OMT in clinical practice.   
 
 

References  
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on Concussion in Sport. Clinical Journal of Sport Medicine 2010, 20(4),  332.  
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Statistical Plan (last update on July 15, 2017) 
 
JMP version 14.1 (SAS Institute Inc) was used for statistical analysis. Descriptive 
statistics (mean, median, SD) and graphical (box plots, bar charts) methods were used. 
For the treatment group, a paired Wilcoxon signed rank test was performed to assess the 
change in VAS data from pretreatment to posttreatment. With 10 patients, we had 89% 
power to detect a change of 2 in the VAS scores from pretreatment to posttreatment, 
assuming a 2-sided significance level of 5% and a standard deviation of 2 (effect size =1). 
The Wilcoxon rank sum test for continuous (eg, age) and discrete (eg. variables (eg, 
change in HIT-6 scores, time from injury to visit [months]) and the Pearson x2 
test for categorical variables (eg, mechanism of injury, history of prior MTBI) were 
performed for comparison of the treatment and control groups. With 20 patients (10 per 
group), we had 80% power to detect a difference in the means of 10 between the 
groups in HIT-6, assuming a standard deviation of 8, and a 2-sided significance level of 
5%. Two-sided P value <.05 was considered statistically significant.