Chiropractic Care for Episodic Migraine

July 3, 2025 updated by: Peter M. Wayne, Ph.D., Brigham and Women's Hospital
Migraine, a chronic intermittent headache disorder, ranks in the top five causes of years lived with disability. One promising non-pharmacologic and integrative treatment for migraine may be chiropractic care due to the co-occurrence of migraine and musculoskeletal complaints. The goal of this application is to perform a pilot study of chiropractic care for episodic migraine to help inform the design of a future, full-scale pragmatic effectiveness trial.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Migraine, a chronic intermittent headache disorder, ranks in the top five causes for years lived with disability. Due to the high disability burden associated with migraine, individuals who experience migraine often seek treatments to reduce the frequency and severity of their attacks and often express interest in nonpharmacologic and integrative approaches. One promising treatment may be chiropractic care due to the comorbidity of migraine and musculoskeletal complaints.

Our long-term goal is to conduct a multi-site large-scale, fully powered trial evaluating the effectiveness of a validated multimodal chiropractic care intervention to reduce migraine frequency, severity, and disability.

To help inform the design of a large-scale trial with both pragmatic and explanatory features, we propose to conduct a two-arm pilot randomized attention-controlled trial at two sites which are representative of sites to be included in the future large-scale trial. We will recruit and randomize 60 individuals (30 per site) to either 1) 14 visits of chiropractic care (CC) (6 visits of CC over 3-5 weeks followed by 8 visits of CC over 12 weeks); or 2) 14 sessions of headache health education (15-minute 1:1 virtual sessions focused on pre-defined migraine specific topics) - both added to usual medical care. This study will allow us to address the following aims: 1) To train a team of chiropractors from established clinics within two academic medical centers with existing partnerships with headache programs, refine our intervention, and assess the fidelity of intervention protocols; 2) To optimize data collection, data management, and reporting procedures across sites and establish the infrastructure needed for a large-scale trial; 3) To assess the feasibility of recruitment, retention, and adherence across multiple study sites; 4) To assess participant expectations and treatment experience.

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Osher Center for Integrative Health, Mass General Brigham
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter Wayne, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Age 18-65 years
  • Confirmed diagnosis of migraine with or without aura which does not meet criteria for chronic migraine according to the International Classification for -Headache Disorders (ICHD)-3 guidelines at the screening visit with the study physician
  • History of migraines dating for at least one year
  • Completion of at least 26 headache diary days out of 28
  • Confirmed migraine frequency ≥4 to ≤13 days per month during a run-in period
  • If use of medication is applicable, dose must be stable for 2 months prior to study enrollment
  • If use of medication for non-migraine pain condition is applicable (with the exception of episodic tension type headache), dose must be stable for 2 months prior to study enrollment
  • Willing and able to complete all study procedures and be randomized to either of the two intervention groups
  • Fluency in English
  • Confirmed access to and proficiency with use of a smartphone, computer, and/or tablet
  • Working email address or willingness to create an email account for the study

Exclusion Criteria

  • Non-Veterans (VAMC only)
  • Received botulinum toxin treatment for headache and/or neck pain within the 4 months prior to the start of the baseline phase
  • Received chiropractic care for any condition within the 3 months prior to the start of the baseline phase
  • Received behavioral interventions (e.g., cognitive behavioral therapy, acceptance and commitment therapy, mindfulness, relaxation techniques, hypnosis) within the past 3 months)
  • Used neuromodulation (i.e., "headache devices"), procedures for migraine prevention within the 2 months before the baseline period, or investigational medications or headache devices for at least 90 days prior to screening
  • Diagnosis of medication overuse headache according to the ICHD-3 guidelines at the screening visit with the study physician
  • Traumatic Brain Injury ≤ 1 year before screening visit or worsening of migraine as noted by the screening study physician
  • Head or neck trauma within the past year causing neurological or musculoskeletal signs or symptoms requiring treatment
  • Any medical, neurologic, or psychiatric condition that the screening study physician deems would lead to difficulty complying with the protocol or negatively impact the safety profile of the interventions
  • Psychiatric hospitalization in the last 6 months
  • Receiving hospice or palliative care
  • History of carotid or vertebral artery dissection
  • Presence of carotid bruits
  • Presence of contraindications (relative or absolute) for spinal manipulation or mobilization where these procedures cannot be modified for safe administration and are consistent with those published by the World Health Organization (WHO) guidelines, including but not limited to:
  • Local spinal hypermobility/instability
  • Conditions causing general spinal hypermobility, such as Marfan, Ehlers-Danlos syndrome, and Osteogenesis imperfecta
  • Malignancy of the spine or spinal cord
  • Frank disc herniation with signs of progressive neurological deficit
  • Spinal or intracanalicular hematomas Inflammatory spondyloarthropathies such as rheumatoid arthritis
  • Spinal fractures or dislocations
  • Avascular necrosis in an area of proposed joint manipulation
  • Bone-weakening disorders affecting the spine, such as benign bone tumors, infection, or osteoporosis
  • Vertebrobasilar insufficiency syndrome
  • Aneurysm involving a major blood vessel in an area of potential joint manipulation
  • History of stroke
  • Anticoagulant therapy or blood disorders cause significant bleeding tendency
  • Cervical spine congenital anomalies that affect the stability or neurologic integrity of the individual or history of cervical spine surgery
  • Either self-reported current alcohol or substance use disorder or current alcohol or substance use disorder documented by a treating medical provider within the past 6 months
  • Hormone replacement therapy for less than six months, or if prescriptions greater than 6 months in duration must be at a stable dose
  • Significant cognitive impairment that would impair participation in the trial
  • Currently pregnant or intention to become pregnant within the next six months

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Headache Health Education (HHE)
Participants randomized to Headache Health Education (HHE) will receive 14 interactive 15-minute education sessions delivered via videoconference.
Behavioral: Headache Health Education

Participants randomized to the HHE arm will receive 14 interactive 15-minute education sessions delivered via video conference.

To partially control for attention and expectation associated with chiropractic care, participants randomized to the control group will receive a modified version of a headache education intervention we employed in our pilot study. Participants randomized to HHE will receive 14 interactive 15-minute education sessions delivered via VA or MGB Teams. Material to be covered will focus on pre-defined migraine-specific topics, compared with the control for our pilot study, in addition to greater contact time, HHE will be delivered in a more interactive manner utilizing active learning principles known to support adult learning. We will also utilize publicly available short videos (e.g., from the American Headache Society) followed by scripted discussions with the participant. Example topics include the physiology of migraine or the contribution of life.
Experimental: Chiropractic Care
4 sessions of chiropractic care (6 sessions of chiropractic care over 3-5 weeks followed by 8 sessions of chiropractic care over 12 weeks); participants will be allowed to continue usual care throughout the study.
Procedure: Chiropractic Care
The chiropractic care protocol can be personalized to the patient's clinical needs and follows the scope of chiropractic care practice in the Commonwealth of Massachusetts and the State of Connecticut. Components of the chiropractic intervention include: posture correction / spinal stabilization exercises; soft tissue relaxation techniques; spinal manipulation (i.e. chiropractic adjustment) / mobilization; breathing and relaxation techniques; stretches, self-care; ergonomic modifications; bracing and supports.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment feasibility (average number of participants per month)
Time Frame: 16 months
Each site will be able to recruit 30 participants within 16 months
16 months
Retention feasibility (proportion of participants not lost to follow-up)
Time Frame: 20 weeks
Retention will be quantified by the proportion of subjects who record their migraines for at least 26 out of 28 days and all questionnaires at each outcome assessment.
20 weeks
Intervention adherence feasibility
Time Frame: 15 weeks
Adherence will be calculated as the proportion of subjects who attend at least 80% of the chiropractic care visits or 80% of the one-on-one headache health education video-conferences.
15 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of responders
Time Frame: Change from baseline to initial follow-up (16 weeks) and change from baseline to final follow-up (20 weeks).
Proportion of individuals who experience a ≥50% reduction in migraine days.
Change from baseline to initial follow-up (16 weeks) and change from baseline to final follow-up (20 weeks).
Average severity of migraine attacks
Time Frame: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.
Average severity of migraine attacks (on a 1 to 10 scale) as recorded in migraine diaries.
Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.
Average number of hours for a migraine attack (duration)
Time Frame: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.
Average number of hours a migraine attack lasted as recorded in migraine diaries.
Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.
Average number of medications used for a migraine attack
Time Frame: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.
Average number of medications used to treat a migraine attack as recorded in migraine diaries
Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.
Neck Disability Index (NDI)
Time Frame: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.

Self-report questionnaire used to determine how neck pain impacts daily activities of living and self-related neck pain disability.

Score range: 10 - 60. Higher scores indicate greater disability.
Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.
Headache Related Disability (HIT-6)
Time Frame: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.
HIT-6 is a validated 6-item assessment that evaluates the impact headaches have on a participant's life. Score range: 36 - 78. Higher scores indicate greater disability.
Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.
Migraine Specific Quality of Life Questionnaire, version 2.1 (MSQv2.1)
Time Frame: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.

Migraine Specific Quality of Life Questionnaire, version 2.1 (MSQv2.1) is a validated 14-item questionnaire; it is one of the most frequently used disability instrument in migraine research and is highly reliable.

Participants are asked to provide their response to each question using a standard six point Likert-type scale (none of the time; a little bit of the time; some of the time; a good bit of the time; most of the time; all of the time). Each MSQoL v.2.1 dimension is scored independently from 0 to 100 such that a higher score indicates a better quality of life.
Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time Frame: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.

PROMIS-29 is a system of validated, highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being.

PROMIS-29 v2. 0 profile measure assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items for each domain.The patients' answers to the PROMIS-29 are scored from 1-5 (with the exception of the NRS). The sum of the PROMIS results in the raw score, which lies between 4 and 20. There is no total score, but each axis forms its own score.
Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.
PTSD Checklist for DSM-5 (PCL-5)
Time Frame: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.
20-item self-report measure of the DSM-5 symptoms of PTSD. Score range: 0 - 5. Higher scores are associated with greater likelihood of PTSD.
Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time Frame: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.

Godin Leisure-Time Exercise Questionnaire will be used to measure the amount and intensity of general exercise during the study period. This validated instrument consists of 4 items measuring the frequency of light, moderate, and vigorous-intensity leisure-time physical activity. In the GLTEQ, individuals are asked to complete a self-explanatory, brief four-item query of usual leisure-time exercise habits.

Higher score indicate more leisure-time exercise per week.
Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.
The Expectations for Complementary and Alternative Medicine Treatments Questionnaire short form (EXPECT)
Time Frame: Assess only at baseline following the 4 weeks run-in phase but before randomization.

EXPECT Questionnaire (short form) is a recently developed and validated questionnaire used to assess individuals' expectations of treatments for chronic pain.

Score range: 0 - 40. Higher scores indicate higher expectation of recovery after treatment.
Assess only at baseline following the 4 weeks run-in phase but before randomization.
Number of days with migraine headaches
Time Frame: Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.
Number of migraine headaches as recorded in migraine diaries.
Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.

Collaborators and Investigators

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

Sponsor

Brigham and Women's Hospital

Collaborators

Yale University
VA Connecticut Healthcare System
National Center for Complementary and Integrative Health (NCCIH)
Palmer College of Chiropractic

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)

March 22, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 3, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023P003554
  • R01AT012228-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Investigators interested in using data from this trial will be directed to contact the multiple principle investigators for data access.

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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