OBJECTIVE: To test the hypothesis that home- and community-based exercise, prescribed according to the spinal cord injury (SCI) exercise guidelines, reduces chronic pain.
DESIGN: Single-blinded, pragmatic randomized controlled trial with 2 arms (exercise intervention, waitlist control) and assessments at baseline, 3 months, and 6 months.
SETTING: Testing at 2 university-based laboratories located on separate campuses within the same institution. Exercise in participants' preferred locations.
PARTICIPANTS: Forty-six adults with SCI (76% men/male; 59% paraplegic; Mage=50.6±14.1; Myears since injury=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 counselors 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 proinflammatory cytokines.
RESULTS: In intent-to-treat analyses, the estimated treatment effect (95% CI) on SF-36 Pain was 7.9 (-1.9 to 17.7; P=.11) at 6 months. Tipping-point analyses suggested that these effects may have been significant if the target sample size had been achieved. Treatment effects for ISCIPBDS pain intensity were -1.8 (-3.4, -0.1; P=.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<0.05). 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.
| Discipline Area | Score |
|---|---|
| Physician |  |
Physician rater
A pragmatic, single-blind, randomized controlled trial with a smaller-than-planned sample size because of the COVID-19 pandemic. The study did not demonstrate a benefit regarding the primary endpoint (SF-36 Pain), showing a non-statistically significant improvement at 6 months (p=0.11), possibly due to the study being underpowered. Regarding the secondary outcome (ISCIPBDS), a significant reduction in pain intensity was observed at 3 and 6 months (approximately -1.8 points), with more patients achieving a clinically relevant reduction (>30%). There is a need for larger pragmatic studies.
, McMaster University