Chiropractic Care for Episodic Migraine

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Osher Center for Integrative Health, Mass General Brigham
RECRUITING
Boston
Contact Information
Primary
Pamela M Rist, ScD
prist@mail.harvard.edu
617-278-0835
Backup
Viviane Nguyen, BS
Vnguyen11@bwh.harvard.edu
617-525-9836
Time Frame
Start Date: 2025-03-22
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: National Center for Complementary and Integrative Health (NCCIH), Yale University, Palmer College of Chiropractic, VA Connecticut Healthcare System

This content was sourced from clinicaltrials.gov