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

NCT ID: NCT01620983

Last Updated: 2018-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 402 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2018-06-30

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pain Coping Skills Training

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.

Group Type: EXPERIMENTAL

Pain Coping Skills Training

Intervention Type: BEHAVIORAL

Arthritis Education

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.

Group Type: ACTIVE_COMPARATOR

Arthritis Education

Intervention Type: BEHAVIORAL

Usual Care

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

Group Type: OTHER

Usual Care

Intervention Type: OTHER

Interventions

Pain Coping Skills Training

Intervention Type: BEHAVIORAL

Arthritis Education

Intervention Type: BEHAVIORAL

Usual Care

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel L. Riddle, Ph.D., PT

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Southern Illinois University

Springfield, Illinois, United States

New York University

New York, New York, United States

Duke University

Durham, North Carolina, United States

Wake Forest University

Winston-Salem, North Carolina, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21530943 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20670911 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29543659 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29191188 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22906061 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32990311 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32144884 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1UM1AR062800-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM14326

Identifier Type: -

Identifier Source: org_study_id