Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial (KASTPain)
18 oktober 2018 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
402
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Illinois
-
Springfield, Illinois, Förenta staterna, 19679
- Southern Illinois University
-
-
New York
-
New York, New York, Förenta staterna, 10003
- New York University
-
-
North Carolina
-
Durham, North Carolina, Förenta staterna, 27710
- Duke University
-
Winston-Salem, North Carolina, Förenta staterna, 27157
- Wake Forest University
-
-
Virginia
-
Richmond, Virginia, Förenta staterna, 23298
- Virginia Commonwealth University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
45 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
|
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.
|
|
|
Övrig: Usual Care
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
WOMAC Physical Function Scale
Tidsram: 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
Tidsram: twelve months
|
An 11 point verbal pain rating scale with higher scores denoting higher pain intensity.
|
twelve months
|
|
Pain Catastrophizing Scale
Tidsram: 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
Tidsram: twelve months
|
11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery.
|
twelve months
|
|
Six-minute Walk Test
Tidsram: twelve months
|
Distance walked in six minutes.
|
twelve months
|
|
Short Physical Performance Battery
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Daniel L. Riddle, Ph.D., PT, Virginia Commonwealth University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 december 2012
Primärt slutförande (Faktisk)
27 juni 2017
Avslutad studie (Faktisk)
30 juni 2018
Studieregistreringsdatum
Först inskickad
13 juni 2012
Först inskickad som uppfyllde QC-kriterierna
14 juni 2012
Första postat (Uppskatta)
15 juni 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 oktober 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 oktober 2018
Senast verifierad
1 oktober 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HM14326
- 1UM1AR062800-01 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Individual participant data that underlie the results of the main trial, after de-identification.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .