Abstract
Background: Persistent pain after extremity fracture requiring surgical repair is common and associated with long-term morbidity. We sought to determine whether app-based cognitive behavioural therapy (CBT) reduces persistent postsurgical pain after fracture repair.Methods: We performed a randomized controlled trial of adults from 11 American and Canadian hospitals with an extremity fracture treated with internal fixation. We allocated participants 1:1 to an app-based CBT program or usual care, and followed them at 3, 6, 9, and 12 months post-fracture. Our primary outcome was moderate-to-severe persistent post-surgical pain. We constructed a mixed-effects log-binomial model to explore the effect of CBT versus usual care on moderate-to-severe persistent post-surgical pain over 12 months postfracture.
Results: We randomized 1009 participants to app-based CBT (n = 506) or usual care (n = 503). The mean age of participants was 44.5 years, and 129 (12.8%) presented with an open fracture. Adherence to CBT was modest, with 237/506 patients (46.8%) completing all 7 modules. App-based CBT, compared with usual care, did not reduce the risk of persistent postsurgical pain over 12 months postfracture (30.8% v. 30.3%, adjusted relative risk 1.02, 95% confidence interval [CI] 0.89 to 1.16). The 365-day probability of returning to leisure activities without restrictions was 29.0% in the intervention group and 22.4% in the control group (hazard ratio 1.33, 95% CI 1.00 to 1.77). The other secondary outcomes showed no significant differences between treatments.
Interpretation: Among adults with an operatively managed extremity fracture, app-based CBT did not reduce the risk of persistent postsurgical pain over 12 months. Future research is warranted to develop more effective CBT approaches for adults with extremity fractures and to evaluate alternative supportive interventions that may be more acceptable to patients with fracture.