A SMART design to determine the optimal treatment of chronic pain among military personnel

Contemp Clin Trials. 2018 Oct;73:68-74. doi: 10.1016/j.cct.2018.08.008. Epub 2018 Aug 24.

Abstract

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.

Keywords: Chronic pain; Complementary therapies; Integrative health therapies; Military; Rehabilitation; SMART design.

Publication types

  • Clinical Trial Protocol
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Acupuncture Therapy
  • Catastrophization / psychology
  • Chronic Pain / psychology
  • Chronic Pain / rehabilitation*
  • Complementary Therapies*
  • Humans
  • Manipulation, Chiropractic
  • Military Personnel*
  • Occupational Therapy*
  • Patient Education as Topic
  • Physical Therapy Modalities*
  • Self Efficacy
  • Stress Disorders, Post-Traumatic / psychology
  • Yoga