The Integrative Migraine Pain Alleviation through Chiropractic Therapy (IMPACT) trial: Study rationale, design and intervention validation.

introductionApproximately 15% of the US population experiences migraine, with women afflicted three times as often as men. While medications are often used as first-line treatments, up to 50% of people with migraine pursue complementary and integrative medicine. One promising non-pharmacological approach for migraine is chiropractic care, due to the co-occurrence of migraine disease and musculoskeletal tension and pain. To date, no large-scale trials have evaluated the impact of a comprehensive model of chiropractic care on migraine.

methodsThe Integrative Migraine Pain Alleviation through Chiropractic Therapy (IMPACT) study is a two-arm pilot pragmatic randomized clinical trial evaluating a multimodal chiropractic care intervention plus enhanced usual care (UC) vs. enhanced UC alone for adult women with episodic migraine. A total of 60 women aged 20-55 who meet criteria for episodic migraine will be randomly assigned to an evidence-informed, musculoskeletal focused multimodal chiropractic care (10 sessions over 14 weeks) plus enhanced UC vs. enhanced UC alone. Enhanced UC includes conventional care, migraine education materials, and biweekly check-in phone calls. Study specific aims include: 1) Determine safety and feasibility of the study design; 2) Provide preliminary data on the effectiveness of chiropractic care on migraine frequency, severity, duration and medication use; and 3) Provide preliminary estimates of the effects of chiropractic care on disability, health-related quality of life, and psychosocial well-being. DISCUSSION: Findings will be used to inform the design of a full-scale trial evaluating chiropractic care for women with episodic migraines.