Chiropractic Care for Episodic Migraine

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06229834
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Chiropractic Care — PROCEDURE
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Mar 22, 2025
Status verified
Jul 2025
Primary completion
Apr 1, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

Recruitment feasibility (average number of participants per month) [ Time Frame: 16 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Osher Center for Integrative Health, Mass General BrighamBostonMassachusetts02215
Viviane Nguyen, BS
[email protected]
617-525-9836
Peter Wayne, PhD
[email protected]
617-732-6271
Peter Wayne, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Migraine
By specialty
Neurology
By research site
Osher Center for Integrative Health, Mass General Brigham· Boston, MA

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