Wayne P M, Bernstein C, Kowalski M, Connor J P, Osypiuk K, Long C R, Vining R, Macklin E, Rist P M
Osher Center for Integrative Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA.
Division of Preventive Medicine, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA.
Contemp Clin Trials Commun. 2020 Jan 22;17:100531. doi: 10.1016/j.conctc.2020.100531. eCollection 2020 Mar.
Approximately 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.
The 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.
Findings will be used to inform the design of a full-scale trial evaluating chiropractic care for women with episodic migraines.
约15%的美国人口患有偏头痛，女性患病几率是男性的三倍。虽然药物常被用作一线治疗方法，但高达50%的偏头痛患者会寻求补充和整合医学。由于偏头痛疾病与肌肉骨骼紧张和疼痛同时存在，脊椎按摩疗法是一种很有前景的偏头痛非药物治疗方法。迄今为止，尚无大规模试验评估全面的脊椎按摩疗法模型对偏头痛的影响。
通过脊椎按摩疗法缓解偏头痛疼痛（IMPACT）研究是一项双臂试点实用随机临床试验，评估多模式脊椎按摩疗法干预加强化常规护理（UC）与单独强化UC对发作性偏头痛成年女性的效果。共有60名年龄在20至55岁之间、符合发作性偏头痛标准的女性将被随机分配到基于证据的、以肌肉骨骼为重点的多模式脊椎按摩疗法组（14周内进行10次治疗）加强化UC组与单独强化UC组。强化UC包括常规护理、偏头痛教育材料和每两周一次的随访电话。研究的具体目标包括：1）确定研究设计的安全性和可行性；2）提供关于脊椎按摩疗法对偏头痛频率、严重程度、持续时间和药物使用效果的初步数据；3）提供脊椎按摩疗法对残疾、健康相关生活质量和心理社会幸福感影响的初步估计。
研究结果将用于为评估发作性偏头痛女性脊椎按摩疗法的全面试验设计提供信息。
