Recruiting

Chiropractic Care

Sponsor:

Brigham and Women's Hospital

Code:

NCT06229834

Conditions

Episodic Migraine

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Chiropractic Care

Headache Health Education

Study Details

Brief 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.

Conditions

Episodic Migraine

Study ID

NCT06229834

Start date

Mar 22, 2025

Status verified date

Jun, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

other: Headache Health Education (HHE)

Participants randomized to Headache Health Education (HHE) will receive 14 interactive 15-minute education sessions delivered via videoconference.

Interventions

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.

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.

Primary outcome measure

  • Recruitment feasibility (average number of participants per month) [ Time Frame: 16 months ]
  • Retention feasibility (proportion of participants not lost to follow-up) [ Time Frame: 20 weeks ]
  • Intervention adherence feasibility [ Time Frame: 15 weeks ]

Central Contacts and Locations

Central contacts

Pamela M Rist, ScD

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

Viviane Nguyen, BS

617-525-9836Vnguyen11@bwh.harvard.edu

Locations

Osher Center for Integrative Health, Mass General Brigham

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Viviane Nguyen, BS

617-525-9836vnguyen11@bwh.harvard.edu

Peter Wayne, PhD

617-732-6271pwayne@bwh.harvard.edu

Principal Investigator:

Peter Wayne, PhD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • migraine
  • headache disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-06-26.