Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial (KASTPain)
18 octobre 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
402
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Illinois
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Springfield, Illinois, États-Unis, 19679
- Southern Illinois University
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New York
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New York, New York, États-Unis, 10003
- New York University
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North Carolina
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Durham, North Carolina, États-Unis, 27710
- Duke University
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Winston-Salem, North Carolina, États-Unis, 27157
- Wake Forest University
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Virginia
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Richmond, Virginia, États-Unis, 23298
- Virginia Commonwealth University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
45 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Autre: Usual Care
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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WOMAC Physical Function Scale
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Daniel L. Riddle, Ph.D., PT, Virginia Commonwealth University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 décembre 2012
Achèvement primaire (Réel)
27 juin 2017
Achèvement de l'étude (Réel)
30 juin 2018
Dates d'inscription aux études
Première soumission
13 juin 2012
Première soumission répondant aux critères de contrôle qualité
14 juin 2012
Première publication (Estimation)
15 juin 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 octobre 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 octobre 2018
Dernière vérification
1 octobre 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HM14326
- 1UM1AR062800-01 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Individual participant data that underlie the results of the main trial, after de-identification.
Délai de partage IPD
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.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
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