Clinical trial NCT01620983: Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial
Official title: Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: arthroplasty
pain
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2012-06-15
Enrollment: 402
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale
timeFrame: twelve months
Secondary outcomes:
measure: WOMAC Physical Function Scale
timeFrame: twelve months
measure: 0 to 10 Verbal Pain Rating Scale
timeFrame: twelve months
measure: Pain Catastrophizing Scale
timeFrame: twelve months
measure: Global Rating of Change Scale
timeFrame: twelve months
measure: Six-minute Walk Test
timeFrame: twelve months
measure: Short Physical Performance Battery
timeFrame: twelve months
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Southern Illinois University
state: Illinois
city: New York
country: United States
facility: New York University
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Daniel L. Riddle, Ph.D., PT
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.
citation: Orndahl CM, Perera RA, Riddle DL. Associations Between Physical Therapy Visits and Pain and Physical Function After Knee Arthroplasty: A Cross-Lagged Panel Analysis of People Who Catastrophize About Pain Prior to Surgery. Phys Ther. 2021 Jan 4;101(1):pzaa182. doi: 10.1093/ptj/pzaa182.
citation: Riddle DL, Slover J, Keefe FJ, Ang DC, Dumenci L, Perera RA. Racial Differences in Pain and Function Following Knee Arthroplasty: A Secondary Analysis From a Multicenter Randomized Clinical Trial. Arthritis Care Res (Hoboken). 2021 Jun;73(6):810-817. doi: 10.1002/acr.24177.