Osteopathic Manipulative Techniques for the Treatment of Chronic Migraine Headaches

NCT04520425 | Terminated

• 1 other identifier: 00014287
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Migraine, Headache

Keywords

migraine; chronic migraine; osteopathic manipulative therapy

Outcome Measures

Primary Outcomes (6)

• 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

  6 months

• Treatment satisfaction, first treatment

  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

  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

  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

  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

  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 Outcomes (16)

• Headache impact test (HIT-6)

  1st treatment, week 12

• Headache impact test (HIT-6)

  1 month post-intervention, week 24

• Headache impact test (HIT-6)

  3 months post-intervention, week 36

• MIDAS (Migraine Disability Assessment Test)

  1st treatment, week 12

• MIDAS (Migraine Disability Assessment Test)

  3 months post-intervention, week 36

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Osteopathic manipulative therapy PROCEDURE

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

Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (27)

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• Voigt K, Liebnitzky J, Burmeister U, Sihvonen-Riemenschneider H, Beck M, Voigt R, Bergmann A. Efficacy of osteopathic manipulative treatment of female patients with migraine: results of a randomized controlled trial. J Altern Complement Med. 2011 Mar;17(3):225-30. doi: 10.1089/acm.2009.0673. Epub 2011 Mar 8.

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MeSH Terms

Conditions

Headache; Migraine Disorders

Interventions

Manipulation, Osteopathic; Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Massage; Therapy, Soft Tissue

Study Officials

• Robert P Lennon, MD

  Penn State Health Milton S Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 20, 2020
• Study Start: September 8, 2022
• Primary Completion: January 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)