This trial is active, not recruiting.

Condition knee osteoarthritis
Treatments pain coping skills training, arthritis education, usual care
Phase phase 3
Sponsor Virginia Commonwealth University
Collaborator National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Start date December 2012
End date February 2017
Trial size 402 participants
Trial identifier NCT01620983, 1UM1AR062800-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
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.
pain coping skills training
(Active Comparator)
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.
arthritis education
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
usual care

Primary Outcomes

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale
time frame: twelve months

Secondary Outcomes

WOMAC Physical Function Scale
time frame: two, six and twelve months
0 to 10 verbal pain rating scale
time frame: two, six and twelve months
Pain Catastrophizing Scale
time frame: two, six and twelve months
Global Rating of Change Scale
time frame: two, six and twelve months
Patient Health Questionnaire (PHQ-8) Depression Scale
time frame: two, six and twelve months
EuroQol (EQ-5D-5L)
time frame: two, six and twelve months
Healthcare related cost diary
time frame: two, six and twelve months
WOMAC Pain Scale
time frame: two months and six months
Six-minute Walk Test
time frame: twelve months
Short Physical Performance Battery
time frame: twelve months

Eligibility Criteria

Male or female participants at least 45 years old.

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

Additional Information

Official title Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial
Principal investigator Daniel L. Riddle, Ph.D., PT
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Virginia Commonwealth University.