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

NCT01620983 | Completed Results DMC

• 2 other identifiers: HM143261UM1AR062800-01
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 5

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.

Conditions

Knee Osteoarthritis

Keywords

arthroplasty; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• WOMAC Physical Function Scale

  twelve months

• 0 to 10 Verbal Pain Rating Scale

  twelve months

• Pain Catastrophizing Scale

  twelve months

• Global Rating of Change Scale

  twelve months

• Six-minute Walk Test

  twelve months

Study Arms (3)

Pain Coping Skills Training

EXPERIMENTAL

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.

Behavioral: Pain Coping Skills Training

Arthritis Education

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.

Behavioral: Arthritis Education

Usual Care

OTHER

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

Other: Usual Care

Interventions

Pain Coping Skills Training BEHAVIORAL

Pain Coping Skills Training

Arthritis Education BEHAVIORAL

Arthritis Education

Usual Care OTHER

Usual Care

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (5)

Southern Illinois University

Springfield, Illinois, 19679, United States

Location

New York University

New York, New York, 10003, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (7)

• 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.

  PMID: 21530943 BACKGROUND

• 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.

  PMID: 20670911 BACKGROUND

• 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.

  PMID: 29543659 BACKGROUND

• 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.

  PMID: 29191188 BACKGROUND

• 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.

  PMID: 22906061 BACKGROUND

• 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.

  PMID: 32990311 DERIVED

• 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.

  PMID: 32144884 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

No limitations were noted.

Results Point of Contact

• Title: Dr. Daniel L. Riddle
• Organization: Virginia Commonwealth University

dlriddle@vcu.edu

804-828-0234

Study Officials

• Daniel L. Riddle, Ph.D., PT

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: June 15, 2012
• Study Start: December 1, 2012
• Primary Completion: June 27, 2017
• Study Completion: June 30, 2018
• Last Updated: October 19, 2018
• Results First Posted: October 19, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Two years after publication of the primary findings to allow the investigators to publish secondary work from the trial. Data will no longer be available 5 years after publication of the primary findings.
• Access Criteria: Proposals must be submitted to the primary investigator who, along with the co-investigators will review the proposal. Access to the dataset will be granted based on scientific merit of the project, absence of overlap with other projects, and impact of the request on other planned uses of the dataset. A signed data user agreement will be required.

Locations

US (5)