Objective: Persistent post-surgical pain is common among patients undergoing surgery, is detrimental to patients' quality of life, and can precipitate long-term opioid use. The purpose of this randomized controlled trial is to assess the effects of a behavioral intervention offered prior to surgery for patients at risk for poor post-surgical outcomes, including persistent pain and impaired functioning.
Methods: Described herein is an ongoing randomized, patient- and assessor-blind, attention-controlled multisite clinical trial. Four hundred and thirty Veterans indicated for total knee arthroplasty (TKA) with distress and/or pain will be recruited for this study. Participants will be randomly assigned to a one-day (~5 h) Acceptance and Commitment Therapy workshop or one-day education and attention control workshop. Approximately two weeks following their TKA surgery, patients receive an individualized booster session via phone. Following their TKA, patients complete assessments at 1 week, 6 weeks, 3 months, and 6 months.
Results: The primary outcomes are pain intensity and knee-specific functioning; secondary outcomes are symptoms of distress and coping skills. Mediation analyses will examine whether changes in symptoms of distress and coping skills have an impact on pain and functioning at 6 months in Veterans receiving ACT. This study is conducted mostly with older Veterans; therefore, results may not generalize to women and younger adults who are underrepresented in this veteran population.
Conclusions: The results of this study will provide the first evidence from a large-scale, patient- and assessor-blind controlled trial on the effectiveness of a brief behavioral intervention for the prevention of persistent post-surgical pain and dysfunction.
Keywords: ACT; Chronic post-surgical pain; Efficacy; Function; Mechanisms of change; Moderators.
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