A preliminary RCT of a mind body skills based intervention addressing mood and coping strategies in patients with acute orthopaedic trauma

Abstract Objective To test the acceptability and feasibility of a mind body skills-based intervention (RRCB) and estimate its preliminary effect in reducing disability and pain intensity as compared to standard care (SC) in patients with acute musculoskeletal trauma. Design Randomised controlled trial. Setting Level I trauma centre. Patients Adult patients with acute fractures at risk for chronic pain and disability based on scores on two coping with pain measures who presented to an orthopedic trauma center and met inclusion and exclusion criteria. Intervention Participants were randomied to either RRCB with SC or SC alone. Main outcome measurement Disability (short musculoskeletal functional assessment, SMFA) and pain (Numerical Analogue Scale). Secondary outcome measures: coping strategies (Pain Catastrophizing Scale, PCS and Pain Anxiety Scale, PAS) and mood (CESD Depression and PTSD checklist). Results Among the 50 patients consented, two did not complete the initial assessment. Of these, the first four received the intervention as part of an open pilot and the next 44 were randomised (24 RRCBT and 20 UC) and completed initial assessment. We combined the patients who received RRCB into one group, N  = 28. Of the entire sample, 34 completed time two assessments (24 RRCBT and 10 SC). The RRCB proved to be feasible and accepted (86% retention, 28 out of 24 completers). Analyses of covariance ANCOVA showed a significant ( p Conclusion The RRCB is feasible, acceptable and potentially efficacious. Level of evidence Level 1 prognostic.