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

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Behavioral: Arthritis Education; Behavioral: Pain Coping Skills Training; Other: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01620983

1UM1AR062800-01 (U.S. NIH Grant/Contract)

HM14326

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 402 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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 total or unicompartmental 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 6 months 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 to undergo hip or knee arthroplasty within 6 months 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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402 participants in 3 patient groups

Pain Coping Skills Training

Experimental group

Description:

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.

Treatment:

Behavioral: Pain Coping Skills Training

Arthritis Education

Active Comparator group

Description:

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.

Treatment:

Behavioral: Arthritis Education

Usual Care

Other group

Description:

Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.

Treatment:

Other: Usual Care