McKenzie K Roddy1, Derrecka M Boykin2, Katherine Hadlandsmyth3, James N Marchman4, David M Green5, Joseph A Buckwalter6, Lauren Garvin7, Bridget Zimmerman8, Jaewon Bae9, Jordan Cortesi9, Merlyn Rodrigues10, Jennie Embree9, Barbara A Rakel11, Lilian Dindo12. 1. Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States of America. 2. South Central Mental Illness, Research and Clinical Center, Michael E. DeBakey VA Medical Center, Houston, TX, United States of America. 3. Department of Anesthesia, Carver College of Medicine, University of Iowa, Iowa City, IA, United States of America. 4. Department of Psychology, University of Iowa, Iowa City, IA, United States of America. 5. Michael E. DeBakey Veteran Affairs Medical Center, Houston, TX, United States of America. 6. Department of Orthopedics and Rehabilitation, Carver College of Medicine, University of Iowa, United States of America. 7. Department of Psychiatry, University of Iowa Hospitals and Clinics, Iowa City, IA, United States of America. 8. College of Public Health, University of Iowa, Iowa City, IA, United States of America. 9. College of Nursing, University of Iowa, Iowa City, IA, United States of America. 10. Department of Medicine, Baylor College of Medicine, Houston, TX, United States of America. 11. College of Nursing, University of Iowa, Iowa City, IA, United States of America. Electronic address: barbara-rakel@uiowa.edu. 12. Department of Medicine, Baylor College of Medicine, Houston, TX, United States of America; Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, United States of America. Electronic address: lilian.dindo@bcm.edu.
Abstract
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.
RCT Entities:
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.
Authors: Robert R Edwards; Jennifer A Haythornthwaite; Michael T Smith; Brendan Klick; Jeffrey N Katz Journal: Pain Res Manag Date: 2009 Jul-Aug Impact factor: 3.037
Authors: Orazio Caffo; Maurizio Amichetti; Antonella Ferro; Antonio Lucenti; Francesco Valduga; Enzo Galligioni Journal: Breast Cancer Res Treat Date: 2003-07 Impact factor: 4.872