Abstract
BACKGROUND: Sustaining injury is a common consequence of playing sport. At least one in every three recreational athletes with anterior cruciate ligament (ACL) reconstruction do not return to their preinjury sport following treatment. Psychological factors including confidence and fear of new injury exert large effects on returning to sport. The primary aim of this trial is to test whether a custom smartphone application delivering cognitive-behavioural therapy is effective for improving the number of people who return to their preinjury sport and level following ACL reconstruction. METHODS: Participants scheduled for primary ACL reconstruction are recruited prior to surgery from one of six trial sites in Sweden. We aim to recruit 222 participants (111 in each group) for the BANG trial. Participants are randomly allocated to receive either usual rehabilitation care alone or usual rehabilitation care plus the Back in the Game smartphone application intervention. Back in the Game is a 24-week Internet-delivered programme, based on cognitive-behavioural therapy. The primary outcome is return to the preinjury sport and level at 12 months follow-up. The secondary outcomes assess physical activity participation, new knee injuries, psychological factors, quality of life and physical function. Physical activity participation and new injuries are self-reported every two weeks for 12 months, then every 4 weeks to 24 months follow-up. Psychological readiness to return to sport, knee self-efficacy, motivation to participate in leisure time physical activity, knee-related quality of life, and self-reported knee function are also assessed at 3, 6, 9, 12 and 24 months after surgery. A clinical assessment of strength, knee range of motion, effusion and hopping performance is completed by a blinded assessor at 12 months to assess physical function. DISCUSSION: This protocol outlines how we plan to assess the efficacy of a custom smartphone application, delivering cognitive-behavioural therapy to address fear, confidence and recovery expectations, for improving return to sport following serious sports-related musculoskeletal injury. The BANG trial employs a pragmatic design to best reflect the reality of, and inform, clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03959215 . Registered 22 May 2019.