Chiropractic Care for Episodic Migraine

Project Summary/Abstract 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 non- pharmacologic and integrative approaches. One promising treatment may be chiropractic care due to the co- morbidity of migraine and musculoskeletal complaints. We recently completed a pilot single-site multimodal randomized clinical trial among 61 adult women with episodic migraine evaluating chiropractic care (CC) (10 visits over 14 weeks) and enhanced usual care (EUC) versus EUC alone on migraine frequency, severity, duration, and medication use. Recruitment, retention, and adherence to our study protocols were demonstrated to be feasible and preliminary clinical outcomes were promising. 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. However, several important knowledge gaps remain which need to be addressed before undertaking a large- scale study. We need to: 1) recruit and train teams of chiropractors from established chiropractic care clinics, refine our interventions, and assess fidelity of intervention protocols; 2) establish infrastructure in preparation for a multi-site trial including coordinated institutional review board oversight, data sharing agreements, as well as harmonized data collection and reporting procedures across sites; and 3) refine recruitment and retention procedures across multiple settings, and to other groups, particularly men, who were not included in our pilot study. 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 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 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.