Tests chiropractic care for people with episodic migraine

Trial details

Who runs it

Brigham and Women's Hospital

Trial code

NCT06229834

Record updated

26 June 2026

Original description

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.Read full original descriptionShow less

Chiropractic Care for Episodic Migraine

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.

Inclusion: 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: 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; Receiving hospice or palliative care; Hormone replacement therapy for less than six months, or if prescriptions greater than 6 months in duration must be at a stable dose; 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; History of carotid or vertebral artery dissection; Conditions causing general spinal hypermobility, such as Marfan, Ehlers-Danlos syndrome, and Osteogenesis imperfecta; Malignancy of the spine or spinal cord; Bone-weakening disorders affecting the spine, such as benign bone tumors, infection, or osteoporosis; Vertebrobasilar insufficiency syndrome; 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; Significant cognitive impairment that would impair participation in the trial; Non-Veterans (VAMC only); 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; 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; 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; Aneurysm involving a major blood vessel in an area of potential joint manipulation; Currently pregnant or intention to become pregnant within the next six months.

ClinicalTrials.gov NCT06229834