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Open Access Study protocol

A phase III randomized three-arm trial of physical therapist delivered pain coping skills training for patients with total knee arthroplasty: the KASTPain protocol

Daniel L Riddle1*, Francis J Keefe2, Dennis Ang3, Khaled J4, Levent Dumenci5, Mark P Jensen6, Matthew J Bair7, Shelby D Reed8 and Kurt Kroenke9

Author Affiliations

1 Departments of Physical Therapy and Orthopaedic Surgery, Virginia Commonwealth University, Richmond, VA, USA

2 Department of Psychiatry and Behavioral Sciences, Duke Pain Prevention and Treatment Research Program, Duke University, Durham, NC, USA

3 Section of Rheumatology, Wake Forest University, Winston-Salem, NC, USA

4 Department of Orthopaedic Surgery, Southern Illinois University, Springfield, IL, USA

5 Department of Social and Behavioral Health, Virginia Commonwealth University, Richmond, VA, USA

6 Department of Rehabilitation Medicine, University of Washington, Harborview Medical Center, Seattle, WA, USA

7 Roudebush VA Medical Center of Excellence on Implementing Evidence-Based Practice, Indianapolis, IN 46202, USA

8 Duke Clinical Research Institute and Department of Medicine, Duke University School of Medicine, Durham, NC 27715, USA

9 Department of Medicine, Indiana University, Indianapolis, IN, USA

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BMC Musculoskeletal Disorders 2012, 13:149  doi:10.1186/1471-2474-13-149

Published: 20 August 2012

Abstract

Background

Approximately 20% of patients report persistent and disabling pain following total knee arthroplasty (TKA) despite an apparently normally functioning prosthesis. One potential risk factor for unexplained persistent pain is high levels of pain catastrophizing. We designed a three-arm trial to determine if a pain coping skills training program, delivered prior to TKA, effectively reduces function-limiting pain following the procedure in patients with high levels of pain catastrophizing.

Methods/design

The trial will be conducted at four University-based sites in the US. A sample of 402 patients with high levels of pain catastrophizing will be randomly assigned to either a pain coping skills training arm, an arthritis education control arm or usual care. Pain coping skills will be delivered by physical therapists trained and supervised by clinical psychologist experts. Arthritis education will be delivered by nurses trained in the delivery of arthritis-related content. The primary outcome will be change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain scale score 12 months following surgery. A variety of secondary clinical and economic outcomes also will be evaluated.

Discussion

The trial will be conducted at four University-based sites in the US. A sample of 402 patients with high levels of pain catastrophizing will be randomly assigned to either a pain coping skills training arm, an arthritis education control arm or usual care. Pain coping skills will be delivered by physical therapists trained and supervised by clinical psychologist experts. Arthritis education will be delivered by nurses trained in the delivery of arthritis-related content. The primary outcome will be change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain scale score 12 months following surgery. A variety of secondary clinical and economic outcomes also will be evaluated.

Trial Registration

NCT01620983

Keywords:
Knee; Arthroplasty; Coping skills; Pain; Catastrophizing