Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial

• WOMAC Physical Function Scale [ Time Frame: two, six and twelve months ] [ Designated as safety issue: No ]
• 0 to 10 verbal pain rating scale [ Time Frame: two, six and twelve months ] [ Designated as safety issue: No ]
• Pain Catastrophizing Scale [ Time Frame: two, six and twelve months ] [ Designated as safety issue: No ]
• Global Rating of Change Scale [ Time Frame: two, six and twelve months ] [ Designated as safety issue: No ]
  11 point scale ranging from -5 to +5
• PHQ-8 Depression Scale [ Time Frame: two, six and twelve months ] [ Designated as safety issue: Yes ]
• EQ-5D-5L [ Time Frame: two, six and twelve months ] [ Designated as safety issue: No ]
  health status measure to be used in cost analyses
• Healthcare related cost diary [ Time Frame: two, six and twelve months ] [ Designated as safety issue: No ]
  Cost diary completed by all patients and includes days lost from work, outpatient care and inpatient care
• WOMAC Pain Scale [ Time Frame: two months and six months ] [ Designated as safety issue: No ]
• Six-minute Walk Test [ Time Frame: twelve months ] [ Designated as safety issue: No ]
• Short Physical Performance Battery [ Time Frame: twelve months ] [ Designated as safety issue: No ]
  timed balance, chair stand and walking tests

Patients undergoing knee replacement surgery and who have high levels of pain catastrophizing are at risk for poor outcome. The clinical trial is designed to determine if a pain coping skills training intervention delivered by physical therapists and supervised by psychologists is more effective at reducing pain and improving function and is more cost effective than arthritis education or usual care.

Approximately 25% of patients following knee arthroplasty have disabling pain following apparently successful surgery. Recent research suggests that pain catastrophizing plays a key role in determining which patients with knee arthroplasty have a poor outcome. In addition to this evidence, a substantial literature suggests that pain coping skills training is effective for patients with chronic pain but the intervention has not been studied for surgical patients with severe arthritic knee pain. We designed the Knee Arthroplasty pain coping Skills Training (KASTPain) trial to address this research need. This Phase III three-arm randomized clinical trial seeks to combine a strong and diverse group of researchers to examine an important and understudied area in the joint arthroplasty literature. The KASTPain trial will be the first to examine the utility of a perioperative pain coping intervention for this substantial population of patients.

• Behavioral: Pain Coping Skills Training
• Behavioral: Arthritis Education
• Other: Usual Care

• Experimental: Pain Coping Skills Training
  The pain coping skills training will be delivered by physical therapists in eight one-hour sessions by telephone over a 2-month perioperative period. Patients will be taught a variety of skills designed to improve maladaptive pain related thoughts and actions to enhance recovery following arthroplasty.
  Intervention: Behavioral: Pain Coping Skills Training
• Active Comparator: Arthritis Education
  The eight one-hour perioperative arthritis education sessions will be delivered by nurse educators via telephone and will use a presentation and discussion format. Figures and discussion sessions will present information on the nature of arthritis, what to expect following knee arthroplasty, treatment of osteoarthritis, the role of exercise, joint protection and making future treatment decisions.
  Intervention: Behavioral: Arthritis Education
• Usual Care
  Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
  Intervention: Other: Usual Care

• Riddle DL, Keefe FJ, Nay WT, McKee D, Attarian DE, Jensen MP. Pain coping skills training for patients with elevated pain catastrophizing who are scheduled for knee arthroplasty: a quasi-experimental study. Arch Phys Med Rehabil. 2011 Jun;92(6):859-65. Epub 2011 Apr 29.
• Riddle DL, Johnson RE, Jensen MP, Keefe FJ, Kroenke K, Bair MJ, Ang DC. The Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) instrument was useful for refining a randomized trial design: experiences from an investigative team. J Clin Epidemiol. 2010 Nov;63(11):1271-5. Epub 2010 Jun 17.
• Riddle DL, Keefe FJ, Ang D, J K, Dumenci L, Jensen MP, Bair MJ, Reed SD, Kroenke K. A phase III randomized three-arm trial of physical therapist delivered pain coping skills training for patients with total knee arthroplasty: the KASTPain protocol. BMC Musculoskelet Disord. 2012 Aug 20;13(1):149. doi: 10.1186/1471-2474-13-149.

Inclusion Criteria:

• Adults 45 years and older and capable of providing informed consent
• Diagnosis of osteoarthritis as determined by participating orthopaedic surgeons
• Scheduled for an elective unilateral knee arthroplasty no sooner than 1 week and no later than 8 weeks from the time of recruitment
• Score of greater than or = to 16 on the Pain Catastrophizing Scale
• Score of greater than or = to 5 on the WOMAC Pain Scale
• Able to read and speak English

Exclusion Criteria:

• Scheduled for revision arthroplasty surgery
• Underwent contralateral knee arthroplasty surgery or hip arthroplasty surgery within 1 year of currently planned surgery
• Unable to or declines study participation
• Self-reported diagnosis of rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosis, ankylosing spondylitis
• Arthroplasty surgery scheduled because of fracture, malignancy or infection
• Scheduled for bilateral arthroplasty surgery
• Scheduled for unicompartmental arthroplasty surgery
• Plans to undergo hip or knee arthroplasty within one year of current knee arthroplasty
• Score of 20 or greater on the PHQ-8 depression scale
• Score of less than 3 on the six-item cognitive screener