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

August 10, 2023 updated by: Milton S. Hershey Medical Center
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

To be included in this study patients must be:

  1. An adult ≥ 18 years of age and ≤ 60 years of age
  2. 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
  3. 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"
  4. Legally and physically able to consent in English
  5. 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:

  1. Are diagnosed with secondary headache
  2. 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.))
  3. Are less than 18 or more than 60 years of age
  4. Are diagnosed with fibromyalgia.
  5. Have current or prior migraine or other headache treatment with onabotulinumtoxinA (Botox®)
  6. Have received any treatment of neck or head with onabotulinumtoxinA (Botox®) within the past year
  7. Have current or prior (within 12 months) treatment for any condition with Topiramate

  8. 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.

    1. 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))
    2. Unstable mental health disorders
    3. 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
    4. Have had previous osteopathic treatment for migraine or other headache
    5. Have current or past substance abuse disorder
    6. Have current or pending disability payments, applications for disability or litigation for disability.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
Other Names:
  • OMT, myofascial release

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment metrics
Time Frame: 6 months
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
6 months
Treatment satisfaction, first treatment
Time Frame: 1st treatment, week 12
5 point Likert-type scale assessing: treatment satisfaction on the day of treatment and likelihood of continuing treatments.
1st treatment, week 12
Treatment satisfaction, second treatment
Time Frame: 2nd treatment, week 14
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
2nd treatment, week 14
Treatment satisfaction, second treatment
Time Frame: 3rd treatment, week 16
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
3rd treatment, week 16
Treatment satisfaction, second treatment
Time Frame: 4th treatment, week 18
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
4th treatment, week 18
Treatment satisfaction, second treatment
Time Frame: 5th treatment, week 20
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
5th treatment, week 20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache impact test (HIT-6)
Time Frame: 1st treatment, week 12
A validated method of measuring headache morbidity
1st treatment, week 12
Headache impact test (HIT-6)
Time Frame: 1 month post-intervention, week 24
A validated method of measuring headache morbidity
1 month post-intervention, week 24
Headache impact test (HIT-6)
Time Frame: 3 months post-intervention, week 36
A validated method of measuring headache morbidity
3 months post-intervention, week 36
MIDAS (Migraine Disability Assessment Test)
Time Frame: 1st treatment, week 12
A validated method of measuring headache morbidity
1st treatment, week 12
MIDAS (Migraine Disability Assessment Test)
Time Frame: 3 months post-intervention, week 36
A validated method of measuring headache morbidity
3 months post-intervention, week 36
MSQ (Migraine Specific Quality of Life Questionnaire Version 2.1)
Time Frame: 1st treatment, week 12
A validated method of measuring headache morbidity
1st treatment, week 12
MSQ (Migraine Specific Quality of Life Questionnaire Version 2.1)
Time Frame: 1 month post-intervention, week 24
A validated method of measuring headache morbidity
1 month post-intervention, week 24
MSQ (Migraine Specific Quality of Life Questionnaire Version 2.1)
Time Frame: 3 months post-intervention, week 36
A validated method of measuring headache morbidity
3 months post-intervention, week 36
Headache Diary
Time Frame: 2nd treatment, week 14
A validated self-assessment method of measuring headache morbidity
2nd treatment, week 14
Headache Diary
Time Frame: 3rd treatment, week 16
A validated self-assessment method of measuring headache morbidity
3rd treatment, week 16
Headache Diary
Time Frame: 4th treatment, week 18
A validated self-assessment method of measuring headache morbidity
4th treatment, week 18
Headache Diary
Time Frame: 5th treatment, week 20
A validated self-assessment method of measuring headache morbidity
5th treatment, week 20
Headache Diary
Time Frame: 1 month post-intervention, week 24
A validated self-assessment method of measuring headache morbidity
1 month post-intervention, week 24
Headache Diary
Time Frame: 3 months post-intervention, week 36
A validated self-assessment method of measuring headache morbidity
3 months post-intervention, week 36
Medication Use
Time Frame: 3 months post-intervention from electronic health record, week 36
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.
3 months post-intervention from electronic health record, week 36
Healthcare Utilization
Time Frame: 3 months post-intervention from electronic health record, week 36
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.
3 months post-intervention from electronic health record, week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Robert P Lennon, MD, Penn State Health Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2022

Primary Completion (Actual)

January 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

August 13, 2020

First Submitted That Met QC Criteria

August 18, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00014287

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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