Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial (KASTPain)
18 oktober 2018 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
402
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Illinois
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Springfield, Illinois, Verenigde Staten, 19679
- Southern Illinois University
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New York
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New York, New York, Verenigde Staten, 10003
- New York University
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North Carolina
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Durham, North Carolina, Verenigde Staten, 27710
- Duke University
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Winston-Salem, North Carolina, Verenigde Staten, 27157
- Wake Forest University
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Virginia
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Richmond, Virginia, Verenigde Staten, 23298
- Virginia Commonwealth University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
45 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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Actieve vergelijker: 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.
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Ander: Usual Care
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale
Tijdsspanne: twelve months
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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.
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twelve months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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WOMAC Physical Function Scale
Tijdsspanne: twelve months
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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.
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twelve months
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0 to 10 Verbal Pain Rating Scale
Tijdsspanne: twelve months
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An 11 point verbal pain rating scale with higher scores denoting higher pain intensity.
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twelve months
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Pain Catastrophizing Scale
Tijdsspanne: twelve months
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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.
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twelve months
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Global Rating of Change Scale
Tijdsspanne: twelve months
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11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery.
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twelve months
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Six-minute Walk Test
Tijdsspanne: twelve months
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Distance walked in six minutes.
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twelve months
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Short Physical Performance Battery
Tijdsspanne: twelve months
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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.
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twelve months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Daniel L. Riddle, Ph.D., PT, Virginia Commonwealth University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 december 2012
Primaire voltooiing (Werkelijk)
27 juni 2017
Studie voltooiing (Werkelijk)
30 juni 2018
Studieregistratiedata
Eerst ingediend
13 juni 2012
Eerst ingediend dat voldeed aan de QC-criteria
14 juni 2012
Eerst geplaatst (Schatting)
15 juni 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 oktober 2018
Laatste update ingediend die voldeed aan QC-criteria
18 oktober 2018
Laatst geverifieerd
1 oktober 2018
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HM14326
- 1UM1AR062800-01 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
Individual participant data that underlie the results of the main trial, after de-identification.
IPD-tijdsbestek voor delen
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-toegangscriteria voor delen
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 delen Ondersteunend informatietype
- LEERPROTOCOOL
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .