Chiropractic care to reduce episodic migraine attacks.
Chiropractic Care for Episodic Migraine
This pilot will test whether a 14-visit chiropractic care program, compared with headache health education plus usual care, can reduce migraine days and severity in adults with episodic migraine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06229834 on ClinicalTrials.gov |
What this trial studies
This is a two-arm, pilot randomized attention-controlled trial at two academic sites enrolling 60 adults with episodic migraine. Participants are randomized to 14 visits of multimodal chiropractic care delivered over 15 weeks or to 14 brief virtual headache health education sessions, with both arms receiving usual medical care. The trial will train chiropractors at established clinics and collect feasibility, safety, and preliminary effectiveness data to inform a larger pragmatic effectiveness trial. Key outcomes include migraine frequency, severity, and disability measured during and after the intervention.
Who should consider this trial
Good fit: Adults aged 18–65 with a confirmed diagnosis of episodic migraine (4–13 migraine days per month), at least one year of migraine history, stable relevant medications for ≥2 months, English fluency, and access to a smartphone or computer are ideal candidates.
Not a fit: Patients with chronic migraine (>15 headache days per month), unstable medication regimens, inability to attend in-person chiropractic visits, or lacking English proficiency or required technology are unlikely to benefit from this pilot.
Why it matters
Potential benefit: If successful, the intervention could reduce the number and severity of migraine attacks and provide a validated non-drug treatment option for episodic migraine.
How similar studies have performed: Previous research on manual therapies and multimodal chiropractic approaches for headache has been mixed but occasionally promising, so this approach is somewhat supported but not yet definitively proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Osher Center for Integrative Health, Mass General Brigham — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Pamela M Rist, ScD
- Email: prist@mail.harvard.edu
- Phone: 617-278-0835
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.