Osteopathic Manipulative Techniques for the Treatment of Chronic Migraine Headaches (SMART-CM)

This study evaluates a standardized osteopathic manipulative therapy (OMT) as a treatment for chronic migraine headaches. It will determine the feasibility of enrolling patients in standardized osteopathic manipulative therapy trials, the acceptability of this specific treatment to patients, and evaluate its preliminary effectiveness.

In the United States, 12% of adults suffer from migraines. Migraines are categorized as episodic or chronic (CM). CM is less common than episodic, with a prevalence of 2%, but far more debilitating, with three times the annual per capita cost, putting the total U.S. direct and indirect cost estimate of CM at $15.5 billion dollars per year. Compared to patients with episodic migraine, those with CM have a lower quality of life (QoL) and higher utilization of primary and emergency care. CM has only two prophylactic pharmacologic treatment options with efficacy demonstrated through randomized, placebo-controlled trials. One is Topiramate, whose side effects, including fatigue, dizziness, mood changes and suicidal ideation, can compromise patients' QoL and adherence rate to this treatment, which has been estimated as under 25%. The other is onabotulinumtoxinA, whose side effects, including neck pain, eyelid ptosis and worsening headaches, are reported in over 25% of users. Due to these high frequency, debilitating side effects, ¬there is an urgent need to develop effective CM treatments with low side-effect profiles. Osteopathic manipulative treatment (OMT) has been reported to improve episodic and CM symptoms without major side effects. Improvements with OMT include decreased Headache Impact Test (HIT-6) scores, fewer headache days per month and decreased medication use. While promising, these studies have significant limitations, such as small sample sizes and high risk of bias. Further, even higher quality OMT studies rely on the treating physician to select from among several OMT treatment techniques, rather than using a standardized treatment procedure. Together, these limitations led the most recent literature assessment to conclude that, "more study is needed before manipulative therapies can be confidently recommended to prevent and treat headaches." To overcome these limitations, OMT studies for the treatment of CM should apply rigorous methods, including standardized treatment procedures. The investigators have developed a standardized OMT procedure to treat CM. The procedure is repeated every two weeks over a ten week period. Over the past five years it has been successfully used to treat 50 patients with CM in a single family physician's practice. Among the treated patients, 40 reported improved symptoms, and none reported adverse side effects. However, the procedure has not been formally evaluated using rigorous research methods. The specific objectives of this pilot study are to evaluate the feasibility and acceptability of the standardized OMT procedure for CM, and gather preliminary data on its potential efficacy when implemented in a primary care setting. The central hypothesis is that the standardized myofascial release OMT procedure will improve symptoms of CM as measured by improvement in HIT-6, Migraine Disability Assessment (MIDAS), Migraine-Specific Quality-of-Life Questionnaire (MSQ), and self-reported and electronic health record (EHR) medication usage and healthcare utilization. This hypothesis is supported by the investigators' anecdotal clinical success using this approach. The specific aims of this study are: Aim 1: Assess the feasibility of systematically identifying and treating patients with the standardized OMT procedure within the Penn State Health medical system. Feasibility will be measured by the investigators' ability to identify and enroll CM patients in this study. The investigators will enroll 20-40 adult patients with CM who do not have common confounders. This data will inform the recruitment strategy of a future randomized clinical trial (RCT). Aim 2: Assess the acceptability of the standardized OMT procedure. Acceptability will be measured by patient-reported satisfaction and perceived benefit, completion rate and adverse events or side-effects. This data will inform the sample size calculation of a future RCT. Aim 3: Assess the preliminary effectiveness of the standardized OMT procedure. Efficacy will be measured by improvement in HIT-6, MIDAS, and MSQ scores; patient-reported headache frequency, medication usage, and healthcare utilization surveys; and medication and healthcare utilization documented in the EHR. This data will provide estimates of effect size to better inform the sample size calculation of a future RCT.

Consenting chronic migraine patients will receive 3-5 standardized osteopathic manipulative treatments over the course of ten weeks, and will be assessed for acceptance and efficacy of the treatment.

As a single arm trial, all participants will know they are receiving a treatment. While the investigator and outcomes assessor will not know which particular patients reported individual responses, they will know that all patients received the same treatment.

Participants will receive 5 standardized osteopathic manipulative treatments, two weeks apart. (To be considered a study completer, a participant must complete at least 3 of these treatments.) In addition to assessments at intake and during treatments, 1 and 3 months after their last treatment patients will be asked to provide follow-up data. Assessments include the HIT-6, MIDAS, and MSQ surveys, treatment satisfaction assessments, and a headache diary. Participants will also consent to an electronic medical record extraction of medication and healthcare services utilization.

Mandibular: the clinician applies gentle pressure bilaterally to the subject's mandible, in the direction of the patient's clavicles. Frontal: the clinician applies gentle pressure bilaterally to the subject's forehead, in a direction halfway between the parietals and ears. Temporal: the clinician applies gentle pressure bilaterally to the subject's temples, in the direction of the patient's occiput. Parietal: the clinician applies gentle pressure bilaterally to the subject's parietal bones, in the direction of the patient's occipital atlanto joint. Occipital: the clinician applies gentle pressure to the subject's occipital bone, in the direction of the patient's neck.

Number of eligible patients identified through electronic medical record search, number of contacts needed to schedule an appointment, number of consent meetings to enroll a patient, number of patients who complete the study

5 point Likert-type scale assessing: treatment satisfaction on the day of treatment and likelihood of continuing treatments.

5 point Likert-type scale assessing: treatment satisfaction on the day of treatment, likelihood of continuing treatments, and (for treatments 2-5) how helpful the treatments have been overall in managing the subjects' chronic migraine

5 point Likert-type scale assessing: treatment satisfaction on the day of treatment, likelihood of continuing treatments, and (for treatments 2-5) how helpful the treatments have been overall in managing the subjects' chronic migraine

5 point Likert-type scale assessing: treatment satisfaction on the day of treatment, likelihood of continuing treatments, and (for treatments 2-5) how helpful the treatments have been overall in managing the subjects' chronic migraine

5 point Likert-type scale assessing: treatment satisfaction on the day of treatment, likelihood of continuing treatments, and (for treatments 2-5) how helpful the treatments have been overall in managing the subjects' chronic migraine

A measurement of total type and amount of medication used to manage migraines, obtained from patient reports on their Headache Diary and from the electronic medical record at the end of the study.

A measurement of the total type and number of healthcare visits as self reported in the Headache Diary and extracted from the electronic health record at the end of the study.

Inclusion Criteria: To be included in this study patients must be: An adult ≥ 18 years of age and ≤ 60 years of age Enrolled for care at Penn State Hershey Family and Community Medicine as demonstrated by at least one primary care visit within the past 3 years Diagnosed with chronic migraine (as defined by the International Headache Society: "Headache occurring on 15 or more days/month for more than 3 months, which, on at least 8 days/month, has the features of migraine headache" Legally and physically able to consent in English Willing and able to complete seven in-person visits, each approximately 30 minutes in length, over the course of 21 weeks. Exclusion Criteria: Patients will be ineligible to participate in this study if they: Are diagnosed with secondary headache Are pregnant (as reported at the time of enrollment; no pregnancy test is required; patients who become pregnant during the study will be withdrawn from the study. (However, they may continue to receive non-study related OMT treatments through their primary care provider as OMT has been shown to be safe in pregnancy.)) Are less than 18 or more than 60 years of age Are diagnosed with fibromyalgia. Have current or prior migraine or other headache treatment with onabotulinumtoxinA (Botox®) Have received any treatment of neck or head with onabotulinumtoxinA (Botox®) within the past year Have current or prior (within 12 months) treatment for any condition with Topiramate Are determined by the physician administering OMT to have a medical condition, history, or medication that is likely to decrease the efficacy or increase the risk of OMT. Not all patients with the following conditions will be excluded, but some patients with any of the following may be determined to be unlikely to benefit from OMT or at increased risk of OMT, and will be excluded. A history of surgery in the head or neck (except for: uncomplicated dental surgery that is more than 2 years prior and required no significant implantation (i.e., routine wisdom tooth extraction, braces, or root canal)) Unstable mental health disorders Chronic chronic inflammatory disorders, severe osteoporosis, tumors, evidence of central nervous system pathology include facial palsy, abnormality in vision, speech or balance, paresthesia, or weakness Have had previous osteopathic treatment for migraine or other headache Have current or past substance abuse disorder Have current or pending disability payments, applications for disability or litigation for disability.

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