Enhancing the success of functional restoration using complementary and integrative therapies: Protocol and challenges of a comparative effectiveness study in active duty service members with chronic pain.

Chronic pain significantly impairs physical, psychological and social functioning. Among military populations, pain due to injuries sustained both on and off the battlefield is a leading cause of short and long-term disability. Improving the quality of pain care for active duty service members is a major priority of the Department of Defense. This article describes an ongoing comparative effectiveness study which aims to (1) evaluate the benefit of a multimodal complementary and integrative health (CIH) pain management program when added to standard rehabilitative care (SRC) prior to an intensive functional restoration (FR) program compared to SRC alone, and (2) identify factors that predict improvement in pain impact following treatment completion. Using a randomized controlled trial design, active duty service members with pain related to musculoskeletal injury are assigned to a 3-week course of either SRC or SRC combined with CIH therapies prior to beginning a 3-week course of FR. Outcomes are collected at baseline, at the end of stage 1 treatment, post-FR, and at 3- and 6-months post-FR. Outcome measures include provider-measured functional assessments and patient-reported assessment through the Pain Assessment Screening Tool and Outcomes Registry (PASTOR). The military health system provides a supportive environment for implementation of this research protocol. Challenges to conducting the study have included new technology systems at the study site, slower than projected enrollment, and program delivery issues. These challenges have been successfully managed and have not significantly impacted study participant enrollment and completion of study treatments.