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

18. oktober 2018 opdateret af: Virginia Commonwealth University
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

402

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Illinois
      • Springfield, Illinois, Forenede Stater, 19679
        • Southern Illinois University
    • New York
      • New York, New York, Forenede Stater, 10003
        • New York University
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest University
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23298
        • Virginia Commonwealth University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Træning i smertehåndtering
Aktiv komparator: 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.
Adfærdsmæssigt: Arthritis Education
Andet: Usual Care
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
Andet: Sædvanlig pleje

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale
Tidsramme: 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.
twelve months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
WOMAC Physical Function Scale
Tidsramme: 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.
twelve months
0 to 10 Verbal Pain Rating Scale
Tidsramme: twelve months
An 11 point verbal pain rating scale with higher scores denoting higher pain intensity.
twelve months
Pain Catastrophizing Scale
Tidsramme: 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.
twelve months
Global Rating of Change Scale
Tidsramme: twelve months
11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery.
twelve months
Six-minute Walk Test
Tidsramme: twelve months
Distance walked in six minutes.
twelve months
Short Physical Performance Battery
Tidsramme: 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.
twelve months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Virginia Commonwealth University

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Daniel L. Riddle, Ph.D., PT, Virginia Commonwealth University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2012

Primær færdiggørelse (Faktiske)

27. juni 2017

Studieafslutning (Faktiske)

30. juni 2018

Datoer for studieregistrering

Først indsendt

13. juni 2012

Først indsendt, der opfyldte QC-kriterier

14. juni 2012

Først opslået (Skøn)

15. juni 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. oktober 2018

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HM14326
  • 1UM1AR062800-01 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Individual participant data that underlie the results of the main trial, after de-identification.

IPD-delingstidsramme

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.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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