Madigan Army Medical Center, 9040 Jackson Ave, Tacoma, WA 98431, USA.
School of Nursing & Health Studies, University of Washington Bothell, Box 358531, Bothell, WA 98011, USA.
Contemp Clin Trials. 2018 Oct;73:68-74. doi: 10.1016/j.cct.2018.08.008. Epub 2018 Aug 24.
Chronic pain is a leading cause of disability among active duty service members in the U.S. armed forces. Standard rehabilitative care and complementary and integrative health therapies are used for chronic pain rehabilitation. However, the optimal sequence and duration of these therapies has yet to be determined. This article describes a sequential multiple assignment randomized trial (SMART) protocol being used to identify the optimal components and sequence of standard rehabilitative care and complementary and integrative health therapies for reducing pain impact and improving other patient outcomes. Active duty service members referred to Madigan Army Medical Center for treatment of chronic pain are being recruited to the Determinants of the Optimal Dose and Sequence of Functional Restoration and Integrative Therapies study. Study participants are randomized to either standard rehabilitative care (physical and occupational therapy and psychoeducation) or complementary and integrative health therapies (chiropractic, acupuncture, yoga and psychoeducation). Those participants who do not respond to the first 3 weeks of treatment are randomized to receive an additional 3 weeks of either (1) the alternative treatment or (2) the first-stage treatment plus the alternative treatment. This study will also determine factors associated with treatment response that can support clinical decision making, such as baseline fitness, pain catastrophizing, kinesiophobia, post-traumatic stress, pain self-efficacy, and biological indicators. The information gained from this research will be applicable to all integrative chronic pain rehabilitation programs throughout the U.S. Department of Defense and the U.S. Department of Veterans Affairs, and the broader rehabilitation community.
慢性疼痛是美国现役军人残疾的主要原因。标准康复护理和补充及整合健康疗法用于慢性疼痛康复。然而,这些疗法的最佳顺序和持续时间尚未确定。本文介绍了一种序贯多项分配随机试验(SMART)方案,用于确定标准康复护理和补充及整合健康疗法的最佳组成部分和顺序,以减轻疼痛影响和改善其他患者结局。现役军人因慢性疼痛到 Madigan 陆军医疗中心接受治疗,正在被招募参加确定功能恢复和整合疗法最佳剂量和顺序的研究。研究参与者被随机分配到标准康复护理(物理和职业治疗和心理教育)或补充和整合健康疗法(整脊、针灸、瑜伽和心理教育)。那些对前 3 周治疗没有反应的参与者被随机分配再接受 3 周的治疗,要么是(1)替代治疗,要么是(2)第一阶段治疗加替代治疗。本研究还将确定与治疗反应相关的因素,这些因素可以支持临床决策,如基线健康状况、疼痛灾难化、运动恐惧症、创伤后应激、疼痛自我效能和生物指标。这项研究的结果将适用于整个美国国防部和美国退伍军人事务部以及更广泛的康复社区的所有整合慢性疼痛康复项目。