Chiropractic Care for Episodic Migraine
- Conditions
- Episodic Migraine
- Interventions
- Behavioral: Headache Health EducationProcedure: Chiropractic Care
- Registration Number
- NCT06229834
- Lead Sponsor
- Brigham and Women's Hospital
- 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 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Migraine frequency between 4 to 13 days per month during a four week run-in period, and with a history of migraines dating for at least one year;
- Stable use of behavioral interventions or, if not currently using behavioral interventions, agree to not begin new behavioral interventions during this trial;
- Be willing to complete all study procedures and be randomized to all intervention groups;
- Be fluent in English.
- Any major systemic illness or unstable medical condition (e.g. Parkinson's disease, cancer) or psychiatric condition requiring immediate treatment or that could lead to difficulty complying with the protocol;
- History of stroke, carotid artery dissection, or vertebral artery dissection;
- Signs of myelopathy or carotid bruits or evidence of hypermobility during the clinical exam;
- Head or neck trauma within the past year;
- Current alcohol or substance abuse (self-reported);
- Diagnosis of medication overuse headache (International 3rd Classification of Headache Disorders-edition);
- Currently or recently (past 6 months) received Botox treatment for migraine;
- Currently or recently received chiropractic care (past 3 months) for any condition;
- Failure to complete baseline migraine logs use during run-in phase.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Headache Health Education (HHE) Headache Health Education Participants randomized to Headache Health Education (HHE) will receive 14 interactive 15-minute education sessions delivered via videoconference. Chiropractic Care Chiropractic Care 4 sessions of chiropractic care (6 sessions of chiropractic care over 3 weeks followed by 8 sessions of chiropractic care over 12 weeks); participants will be allowed to continue usual care throughout the study.
- Primary Outcome Measures
Name Time Method Recruitment feasibility (average number of participants per month) 16 months Each site will be able to recruit 30 participants within 16 months
Intervention adherence feasibility 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.
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. Number of migraine headaches as recorded in migraine diaries; this will be the primary clinical outcome.
Retention feasibility (proportion of participants not lost to follow-up) 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.
- Secondary Outcome Measures
Name Time Method 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. Self-report questionnaire used to determine how neck pain impacts daily activities of living and self-related neck pain disability.
Score range: 10 - 60. Higher scores indicate greater disability.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. Godin Leisure-Time Exercise Questionnaire will be used to measure the amount and intensity of general exercise during the study period. This validated instrument consists of 4 items measuring the frequency of light, moderate, and vigorous-intensity leisure-time physical activity. In the GLTEQ, individuals are asked to complete a self-explanatory, brief four-item query of usual leisure-time exercise habits.
Higher score indicate more leisure-time exercise per week.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 hours a migraine attack lasted as recorded in migraine diaries.
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 severity of migraine attacks (on a 1 to 10 scale) as recorded in migraine diaries.
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. Migraine Specific Quality of Life Questionnaire, version 2.1 (MSQv2.1) is a validated 14-item questionnaire; it is one of the most frequently used disability instrument in migraine research and is highly reliable.
Participants are asked to provide their response to each question using a standard six point Likert-type scale (none of the time; a little bit of the time; some of the time; a good bit of the time; most of the time; all of the time). Each MSQoL v.2.1 dimension is scored independently from 0 to 100 such that a higher score indicates a better quality of life.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. 20-item self-report measure of the DSM-5 symptoms of PTSD. Score range: 0 - 5. Higher scores are associated with greater likelihood of PTSD.
Proportion of responders Change from baseline to initial follow-up (16 weeks) and change from baseline to final follow-up (20 weeks). Proportion of individuals who experience a ≥50% reduction in migraine days.
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. Average number of medications used to treat a migraine attack as recorded in migraine diaries
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. HIT-6 is a validated 6-item assessment that evaluates the impact headaches have on a participant's life. Score range: 36 - 78. Higher scores indicate greater disability.
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. PROMIS-29 is a system of validated, highly reliable, precise measures of patient-reported health status for physical, mental, and social well-being.
PROMIS-29 v2. 0 profile measure assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items for each domain.The patients' answers to the PROMIS-29 are scored from 1-5 (with the exception of the NRS). The sum of the PROMIS results in the raw score, which lies between 4 and 20. There is no total score, but each axis forms its own score.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. EXPECT Questionnaire (short form) is a recently developed and validated questionnaire used to assess individuals' expectations of treatments for chronic pain.
Score range: 0 - 40. Higher scores indicate higher expectation of recovery after treatment.