Community-Based Exercise for Chronic Pain in People with Spinal Cord Injury: A Pragmatic Randomized Controlled Trial

OBJECTIVE: To test the hypothesis that home/community-based exercise, prescribed according to the Spinal Cord Injury (SCI) Exercise Guidelines, reduces chronic pain. DESIGN: Single-blinded, pragmatic randomized controlled trial with two arms (exercise intervention, wait-list control) and assessments at baseline, 3-months, and 6-months. SETTING: Testing at two university-based laboratories located on separate campuses within the same institution. Exercise in participants' preferred locations. PARTICIPANTS: =16.5±12.8) and chronic neuropathic or musculoskeletal pain, who did not routinely achieve the SCI exercise guidelines. INTERVENTION: Intervention participants (n=25) received an individualized exercise prescription for aerobic and strength-training. Fitness trainers and exercise counsellors supported implementation. Control participants (n=21) continued their usual activities. MAIN OUTCOME MEASURES: The primary outcome was the SF-36 Pain score at 6-months. Secondary outcomes were International SCI Pain Basic Dataset version 2.0 (ISCIPBDS) pain-intensity and interference scores, and standardized measures of pain coping, well-being, conditioned pain modulation and pro-inflammatory cytokines. RESULTS: In intent-to-treat analyses, the estimated treatment effect (95% CI) on SF-36 Pain was 7.9 (-1.9,17.7; p=0.11) at 6-months. Tipping-point analyses suggest these effects may have been significant if target sample size had been achieved. Treatment effects for ISCIPBDS pain-intensity were -1.8 (-3.4,-0.1; p=0.04) at 6-months. Relative to controls, participants in the intervention condition reported significant reductions in pain interference at 3-months and reduced use of pain-coping strategies at 6-months (ps<.05). No other effects were significant. CONCLUSIONS: Intervention effects on SF-36 Pain were inconclusive. Analyses of secondary outcomes (ISCIPBDS) suggest exercise prescribed according to the SCI Exercise Guidelines, and implemented in real-world settings, can reduce pain intensity. Meeting the aerobic-exercise guideline may be especially important. Further replication in pragmatic trials is required.