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

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ClinicalTrials.gov Identifier: NCT04520425
Recruitment Status : Not yet recruiting
First Posted : August 20, 2020
Last Update Posted : August 6, 2021
Sponsor:
Information provided by (Responsible Party):
Robert Lennon, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment Phase
Chronic Migraine, Headache Procedure: Osteopathic manipulative therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Osteopathic Manipulative Techniques for the Treatment of Chronic Migraine Headaches
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : October 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

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 Name: OMT, myofascial release




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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


Secondary Outcome Measures :
  1. Headache impact test (HIT-6) [ Time Frame: 1st treatment, week 12 ]
    A validated method of measuring headache morbidity

  2. Headache impact test (HIT-6) [ Time Frame: 1 month post-intervention, week 24 ]
    A validated method of measuring headache morbidity

  3. Headache impact test (HIT-6) [ Time Frame: 3 months post-intervention, week 36 ]
    A validated method of measuring headache morbidity

  4. MIDAS (Migraine Disability Assessment Test) [ Time Frame: 1st treatment, week 12 ]
    A validated method of measuring headache morbidity

  5. MIDAS (Migraine Disability Assessment Test) [ Time Frame: 3 months post-intervention, week 36 ]
    A validated method of measuring headache morbidity

  6. MSQ (Migraine Specific Quality of Life Questionnaire Version 2.1) [ Time Frame: 1st treatment, week 12 ]
    A validated method of measuring headache morbidity

  7. 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

  8. 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

  9. Headache Diary [ Time Frame: 2nd treatment, week 14 ]
    A validated self-assessment method of measuring headache morbidity

  10. Headache Diary [ Time Frame: 3rd treatment, week 16 ]
    A validated self-assessment method of measuring headache morbidity

  11. Headache Diary [ Time Frame: 4th treatment, week 18 ]
    A validated self-assessment method of measuring headache morbidity

  12. Headache Diary [ Time Frame: 5th treatment, week 20 ]
    A validated self-assessment method of measuring headache morbidity

  13. Headache Diary [ Time Frame: 1 month post-intervention, week 24 ]
    A validated self-assessment method of measuring headache morbidity

  14. Headache Diary [ Time Frame: 3 months post-intervention, week 36 ]
    A validated self-assessment method of measuring headache morbidity

  15. 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.

  16. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04520425


Contacts
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Contact: Jessica Wright 7175310003 ext 284713 jwright3@pennstatehealth.psu.edu
Contact: Debbie Firestine 7175316116 dfirestine@pennstatehealth.psu.edu

Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Robert P Lennon, MD Penn State Health Milton S. Hershey Medical Center
Publications:

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Responsible Party: Robert Lennon, Associate Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT04520425    
Other Study ID Numbers: 00014287
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be made available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Lennon, Milton S. Hershey Medical Center:
migraine
chronic migraine
osteopathic manipulative therapy
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations