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

Knee Osteoarthritis Clinical Trial

— KASTPain  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620983
• Other study ID #: HM14326
• Secondary ID: 1UM1AR062800-01
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: June 30, 2018

Study information

• Verified date: October 2018
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: June 30, 2018
• Est. primary completion date: June 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Pain Coping Skills Training

• Arthritis Education

Other:
• Usual Care

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	New York University	New York	New York
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Southern Illinois University	Springfield	Illinois
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Riddle DL, Jensen MP, Ang D, Slover J, Perera R, Dumenci L. Do Pain Coping and Pain Beliefs Associate With Outcome Measures Before Knee Arthroplasty in Patients Who Catastrophize About Pain? A Cross-sectional Analysis From a Randomized Clinical Trial. Clin Orthop Relat Res. 2018 Apr;476(4):778-786. doi: 10.1007/s11999.0000000000000001. — View Citation

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. doi: 10.1016/j.jclinepi.2010.03.006. Epub 2010 Jun 17. — View Citation

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;13:149. doi: 10.1186/1471-2474-13-149. — View Citation

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. doi: 10.1016/j.apmr.2011.01.003. Epub 2011 Apr 29. — View Citation

Riddle DL, Slover J, Ang D, Perera RA, Dumenci L. Construct validation and correlates of preoperative expectations of postsurgical recovery in persons undergoing knee replacement: baseline findings from a randomized clinical trial. Health Qual Life Outcomes. 2017 Dec 1;15(1):232. doi: 10.1186/s12955-017-0810-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale	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.	twelve months
Secondary	WOMAC Physical Function Scale	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.	twelve months
Secondary	0 to 10 Verbal Pain Rating Scale	An 11 point verbal pain rating scale with higher scores denoting higher pain intensity.	twelve months
Secondary	Pain Catastrophizing Scale	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.	twelve months
Secondary	Global Rating of Change Scale	11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery.	twelve months
Secondary	Six-minute Walk Test	Distance walked in six minutes.	twelve months
Secondary	Short Physical Performance Battery	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.	twelve months