Chiropractic Care for Episodic Migraine
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Episodic Migraine
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Recruitment feasibility (average number of participants per month)
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
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.
Detailed Description
Migraine, a chronic intermittent headache disorder, ranks in the top five causes for years lived with disability. Due to the high disability burden associated with migraine, individuals who experience migraine often seek treatments to reduce the frequency and severity of their attacks and often express interest in nonpharmacologic and integrative approaches. One promising treatment may be chiropractic care due to the comorbidity of migraine and musculoskeletal complaints. Our long-term goal is to conduct a multi-site large-scale, fully powered trial evaluating the effectiveness of a validated multimodal chiropractic care intervention to reduce migraine frequency, severity, and disability. To help inform the design of a large-scale trial with both pragmatic and explanatory features, we propose to conduct a two-arm pilot randomized attention-controlled trial at two sites which are representative of sites to be included in the future large-scale trial. We will recruit and randomize 60 individuals (30 per site) to either 1) 14 visits of chiropractic care (CC) (6 visits of CC over 3-5 weeks followed by 8 visits of CC over 12 weeks); or 2) 14 sessions of headache health education (15-minute 1:1 virtual sessions focused on pre-defined migraine specific topics) - both added to usual medical care. This study will allow us to address the following aims: 1) To train a team of chiropractors from established clinics within two academic medical centers with existing partnerships with headache programs, refine our intervention, and assess the fidelity of intervention protocols; 2) To optimize data collection, data management, and reporting procedures across sites and establish the infrastructure needed for a large-scale trial; 3) To assess the feasibility of recruitment, retention, and adherence across multiple study sites; 4) To assess participant expectations and treatment experience.
Investigators
Peter M. Wayne, Ph.D.
Associate Professor of Medicine
Brigham and Women's Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Recruitment feasibility (average number of participants per month)
Time Frame: 16 months
Each site will be able to recruit 30 participants within 16 months
Retention feasibility (proportion of participants not lost to follow-up)
Time Frame: 20 weeks
Retention will be quantified by the proportion of subjects who record their migraines for at least 26 out of 28 days and all questionnaires at each outcome assessment.
Intervention adherence feasibility
Time Frame: 15 weeks
Adherence will be calculated as the proportion of subjects who attend at least 80% of the chiropractic care visits or 80% of the one-on-one headache health education video-conferences.
Secondary Outcomes
- Number of days with migraine headaches(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Proportion of responders(Change from baseline to initial follow-up (16 weeks) and change from baseline to final follow-up (20 weeks).)
- Average severity of migraine attacks(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Average number of hours for a migraine attack (duration)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Average number of medications used for a migraine attack(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Neck Disability Index (NDI)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Headache Related Disability (HIT-6)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Migraine Specific Quality of Life Questionnaire, version 2.1 (MSQv2.1)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Patient-Reported Outcomes Measurement Information System (PROMIS-29)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- PTSD Checklist for DSM-5 (PCL-5)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- Godin Leisure-Time Exercise Questionnaire (GLTEQ)(Assess during three 4-week periods (baseline, initial follow-up, final follow-up) within the total of 24 weeks that participants are enrolled in the trial.)
- The Expectations for Complementary and Alternative Medicine Treatments Questionnaire short form (EXPECT)(Assess only at baseline following the 4 weeks run-in phase but before randomization.)