Skip to main content
OpenTrials
Completed

NCT Number: NCT01620983

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southern Illinois University, Springfield, Illinois, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pain Coping Skills Training

Behavioral

Arthritis education

Behavioral

Usual Care

Other

Primary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale

    Time frame: twelve months

    A self report scale that quantifies the extent of function limiting pain. The scale ranges from 0 to 20 with higher scores denoting worse activity related pain.

Secondary outcomes

  1. WOMAC Physical Function Scale

    Time frame: twelve months

    A self report scale that quantifies the extent of difficulty with everyday activity. The scale ranges from 0 to 68 with higher scores denoting greater difficulty with daily function.

  2. 0 to 10 Verbal Pain Rating Scale

    Time frame: twelve months

    An 11 point verbal pain rating scale with higher scores denoting higher pain intensity.

  3. Pain Catastrophizing Scale

    Time frame: twelve months

    A scale that quantifies the extent to which a participant catastrophizes about their pain. Score range from 0 to 52 with higher scores denoting greater pain catastrophizing.

  4. Global Rating of Change Scale

    Time frame: twelve months

    11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery.

  5. Six-minute Walk Test

    Time frame: twelve months

    Distance walked in six minutes.

  6. Short Physical Performance Battery

    Time frame: twelve months

    The Short Physical Performance Battery measures actual physical performance of four common daily physical activities including standing balance, single standing from a chair, repeated standing from a chair, and a 4 meter walk test. Scores range from 0 to 12 with higher scores indicating better physical performance.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Acronym: KASTPain

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Jun 15, 2012
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.