An interventional study of Osteopathic manipulative therapy in Chronic Migraine, Headache, sponsored by Milton S. Hershey Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Treatment
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 11 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
To be included in this study patients must be:
Exclusion Criteria:
Patients will be ineligible to participate in this study if they:
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.
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.
Procedure: Osteopathic manipulative therapy
1. Mandibular: the clinician applies gentle pressure bilaterally to the subject's mandible, in the direction of the patient's clavicles. 2. Frontal: the clinician applies gentle pressure bilaterally to the subject's forehead, in a direction halfway between the parietals and ears. 3. Temporal: the clinician applies gentle pressure bilaterally to the subject's temples, in the direction of the patient's occiput. 4. Parietal: the clinician applies gentle pressure bilaterally to the subject's parietal bones, in the direction of the patient's occipital atlanto joint. 5. Occipital: the clinician applies gentle pressure to the subject's occipital bone, in the direction of the patient's neck.
Also known as: OMT, myofascial release
Recruitment metrics
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
Time frame: 6 months
Treatment satisfaction, first treatment
5 point Likert-type scale assessing: treatment satisfaction on the day of treatment and likelihood of continuing treatments.
Time frame: 1st treatment, week 12
Treatment satisfaction, second treatment
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
Time frame: 2nd treatment, week 14
Treatment satisfaction, second treatment
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
Time frame: 3rd treatment, week 16
Treatment satisfaction, second treatment
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
Time frame: 4th treatment, week 18
Treatment satisfaction, second treatment
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
Time frame: 5th treatment, week 20
Headache impact test (HIT-6)
A validated method of measuring headache morbidity
Time frame: 1st treatment, week 12
Headache impact test (HIT-6)
A validated method of measuring headache morbidity
Time frame: 1 month post-intervention, week 24
Headache impact test (HIT-6)
A validated method of measuring headache morbidity
Time frame: 3 months post-intervention, week 36
MIDAS (Migraine Disability Assessment Test)
A validated method of measuring headache morbidity
Time frame: 1st treatment, week 12
MIDAS (Migraine Disability Assessment Test)
A validated method of measuring headache morbidity
Time frame: 3 months post-intervention, week 36
MSQ (Migraine Specific Quality of Life Questionnaire Version 2.1)
A validated method of measuring headache morbidity
Time frame: 1st treatment, week 12
MSQ (Migraine Specific Quality of Life Questionnaire Version 2.1)
A validated method of measuring headache morbidity
Time frame: 1 month post-intervention, week 24
MSQ (Migraine Specific Quality of Life Questionnaire Version 2.1)
A validated method of measuring headache morbidity
Time frame: 3 months post-intervention, week 36
Headache Diary
A validated self-assessment method of measuring headache morbidity
Time frame: 2nd treatment, week 14
Headache Diary
A validated self-assessment method of measuring headache morbidity
Time frame: 3rd treatment, week 16
Headache Diary
A validated self-assessment method of measuring headache morbidity
Time frame: 4th treatment, week 18
Headache Diary
A validated self-assessment method of measuring headache morbidity
Time frame: 5th treatment, week 20
Headache Diary
A validated self-assessment method of measuring headache morbidity
Time frame: 1 month post-intervention, week 24
Headache Diary
A validated self-assessment method of measuring headache morbidity
Time frame: 3 months post-intervention, week 36
Medication Use
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.
Time frame: 3 months post-intervention from electronic health record, week 36
Healthcare Utilization
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.
Time frame: 3 months post-intervention from electronic health record, week 36
Plan to share: No — Individual participant data will not be made available to other researchers.
This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Milton S. Hershey Medical Center