Clinical trial NCT06229834: Chiropractic Care for Episodic Migraine
Official title: Chiropractic Care for Episodic Migraine
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Episodic Migraine
Keywords: migraine
headache disorder
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Palmer College of Chiropractic
name: Yale University
name: VA Connecticut Healthcare System
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 (Osher Clinic, BWH, and VA Medical Center, West Haven, CT). We will recruit and randomize 60 individuals (30 per site). Individuals will be randomized (1:1) to: 1) 14 sessions of CC (6 sessions of chiropractic care over 3 weeks followed by 8 sessions of chiropractic care (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. Individuals will be followed for 4 weeks after the end of their intervention period.
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Recruitment feasibility (average number of participants per month)
timeFrame: 16 months
measure: Retention feasibility (proportion of participants not lost to follow-up)
timeFrame: 20 weeks
measure: Intervention adherence feasibility
timeFrame: 15 weeks
measure: Number of days with migraine headaches
timeFrame: 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.
Secondary outcomes:
measure: Proportion of responders
timeFrame: Change from baseline to initial follow-up (16 weeks) and change from baseline to final follow-up (20 weeks).
measure: Average severity of migraine attacks
timeFrame: 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.
measure: Average number of hours for a migraine attack (duration)
timeFrame: 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.
measure: Average number of medications used for a migraine attack
timeFrame: 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.
measure: Neck Disability Index (NDI)
timeFrame: 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.
measure: Headache Related Disability (HIT-6)
timeFrame: 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.
measure: Migraine Specific Quality of Life Questionnaire, version 2.1 (MSQv2.1)
timeFrame: 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.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29)
timeFrame: 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.
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: 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.
measure: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
timeFrame: 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.
measure: The Expectations for Complementary and Alternative Medicine Treatments Questionnaire short form (EXPECT)
timeFrame: Assess only at baseline following the 4 weeks run-in phase but before randomization.
Other outcomes:
Locations:
Study officials:
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