RecruitingNot Applicable

Chiropractic Care for Episodic Migraine

United States60 participantsStarted 2025-03-22

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment feasibility (average number of participants per month)

Timeframe: 16 months

Retention feasibility (proportion of participants not lost to follow-up)

Timeframe: 20 weeks

Intervention adherence feasibility

Timeframe: 15 weeks

Trial details

NCT IDNCT06229834

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-01

Contact for this trial

Pamela M Rist, ScD

617-278-0835 prist@mail.harvard.edu

View on ClinicalTrials.gov More Episodic Migraine trials