Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica
4 août 2026 mis à jour par: Washington University School of Medicine
Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica: a Feasibility Randomized Clinical Trial
Polymyalgia rheumatica (PMR) is a condition that causes joint pain and stiffness, making it hard for people to do everyday tasks.
Movement pattern training is a special, personalized rehabilitation program that aims to reduce pain by improving how people move during their daily activities.
The investigators plan to test if it's possible to conduct a detailed study to find out how effective Movement pattern training is for people with PMR.
The investigators will look at whether it helps them perform activities they want to do, reduce their use of certain medications, and strengthen their muscles.
The investigators will also gather feedback from patients about their experience with Movement pattern training.
This study will help us understand if carrying out a larger study on Movement pattern training's effectiveness is practical.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
20
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.
Coordonnées de l'étude
- Nom: Marcie Harris-Hayes, DPT, MSCI
- Numéro de téléphone: 314-286-1435
- E-mail: harrisma@wustl.edu
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
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Patient reports a diagnosis or flare of polymyalgia rheumatica (PMR) < 5 months before the screening contact
Diagnosis or flare of PMR according to the European League against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria as follows (must satisfy all criteria)10:
- Age ≥50 years at time of diagnosis
- Presence of bilateral shoulder pain
- Elevated acute phase reactants C-reactive protein (CRP) >10 milligram/Liter and/or Erythrocyte Sedimentation Rate (ESR) >30 millimeters/hour*
A score ≥4 at the time of diagnosis based on the following (without ultrasound):
- Duration of morning stiffness >45 minutes: 2 points
- Hip pain or limited range of motion: 1 point
- Seronegative for rheumatoid factor and anti-cyclic citrullinated peptide: 2 points
- Absence of other joint involvement: 1 point
- Initiated pharmacological treatment
- Able to give informed consent
- Physician's clearance to participate in physical activity
Exclusion Criteria:
- Diagnosis of fibromyalgia, neuropathic muscular disease, complex regional pain syndrome, or small fiber neuropathy
- planned major surgical procedure during the study
- Current active uncontrolled infection
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: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Usual Care
Patients will be encouraged to complete their treatment as described by their physician.
|
|
|
Expérimental: Movement Pattern Training (MoveTrain)
Movement pattern Training (MoveTrain) is progressive activity-specific training to improve altered joint motion during patient-specific tasks.
At baseline, each patient identifies specific activities (e.g., getting out of bed), work (e.g., reaching overhead), and physical activities (e.g., cycling) that are difficult due to their pain.
A movement examination is performed to identify the altered joint motion on associated with movement-evoked pain and the motion modification that reduces their pain.
The treatment provider then instructs the patient in activity-specific training, which includes practicing multiple repetitions of the modified activity as their home exercise program.
Patients also are instructed to use the trained modified motion during their daily activities to maximize their use in daily routines.
This encourages frequent practice and potentially greater program sustainability.
|
6 individualized treatment sessions over 10 weeks
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of potential participants accessed.
Délai: 7 months
|
The total number of people with Polymyalgia rheumatica (PMR) who were recruited each week
|
7 months
|
|
Percent of eligible participants who were willing to be randomized
Délai: 7 months
|
Percent of eligible participants are willing to be randomized during the study
|
7 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Preliminary estimates of change in polymyalgia rheumatica impact scale (PMR-IS)
Délai: From enrollment to the end of treatment at 10 weeks
|
The change in polymyalgia rheumatica impact scale (PMR-IS), a self-report questionnaire specific to polymyalgia rheumatica, that represents the patients symptoms and functional ability.
|
From enrollment to the end of treatment at 10 weeks
|
|
Preliminary estimates of change in physical activity
Délai: From enrollment to the end of treatment at 10 weeks
|
The change in physical activity as represented by the Stanford 7-DAy Physical Activity Recall survey
|
From enrollment to the end of treatment at 10 weeks
|
|
Preliminary estimates of change in cumulative glucocorticoid dose
Délai: From enrollment to the end of treatment at 10 weeks
|
Change in cumulative glucocorticoid dose assessed by patient's self-report logs
|
From enrollment to the end of treatment at 10 weeks
|
|
Preliminary estimates of change in muscle strength
Délai: From enrollment to the end of treatment at 10 weeks
|
change in muscle strength of the hips and shoulders, assessed using a hand dynamometer
|
From enrollment to the end of treatment at 10 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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
- Slade SC, Dionne CE, Underwood M, Buchbinder R. Consensus on Exercise Reporting Template (CERT): Explanation and Elaboration Statement. Br J Sports Med. 2016 Dec;50(23):1428-1437. doi: 10.1136/bjsports-2016-096651. Epub 2016 Oct 5.
- Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014 Mar 7;348:g1687. doi: 10.1136/bmj.g1687.
- Mackie SL, Twohig H, Neill LM, Harrison E, Shea B, Black RJ, Kermani TA, Merkel PA, Mallen CD, Buttgereit F, Mukhtyar C, Simon LS, Hill CL; OMERACT PMR Working Group. The OMERACT Core Domain Set for Outcome Measures for Clinical Trials in Polymyalgia Rheumatica. J Rheumatol. 2017 Oct;44(10):1515-1521. doi: 10.3899/jrheum.161109. Epub 2017 Aug 1.
- Harris-Hayes M, Czuppon S, Van Dillen LR, Steger-May K, Sahrmann S, Schootman M, Salsich GB, Clohisy JC, Mueller MJ. Movement-Pattern Training to Improve Function in People With Chronic Hip Joint Pain: A Feasibility Randomized Clinical Trial. J Orthop Sports Phys Ther. 2016 Jun;46(6):452-61. doi: 10.2519/jospt.2016.6279. Epub 2016 Apr 26.
- Twohig H, Mitchell C, Mallen CD, Muller S. Development and psychometric evaluation of the PMR-Impact Scale: a new patient reported outcome measure for polymyalgia rheumatica. Rheumatology (Oxford). 2023 Feb 1;62(2):758-765. doi: 10.1093/rheumatology/keac317.
- Taylor CB, Coffey T, Berra K, Iaffaldano R, Casey K, Haskell WL. Seven-day activity and self-report compared to a direct measure of physical activity. Am J Epidemiol. 1984 Dec;120(6):818-24. doi: 10.1093/oxfordjournals.aje.a113954.
- Harris-Hayes M, Steger-May K, Bove AM, Foster SN, Mueller MJ, Clohisy JC, Fitzgerald GK. Movement pattern training compared with standard strengthening and flexibility among patients with hip-related groin pain: results of a pilot multicentre randomised clinical trial. BMJ Open Sport Exerc Med. 2020 Mar 23;6(1):e000707. doi: 10.1136/bmjsem-2019-000707. eCollection 2020.
- O'Brien AV, Muller S, Liddle J, Thomas MJ, Mallen CD. Physiotherapy for the Management of Polymyalgia Rheumatica: Results From a UK Cross-Sectional Survey. Musculoskeletal Care. 2025 Sep;23(3):e70155. doi: 10.1002/msc.70155.
- Twohig H, Mitchell C, Mallen C, Adebajo A, Mathers N. "I suddenly felt I'd aged": a qualitative study of patient experiences of polymyalgia rheumatica (PMR). Patient Educ Couns. 2015 May;98(5):645-50. doi: 10.1016/j.pec.2014.12.013. Epub 2015 Jan 15.
- Hutchings A, Hollywood J, Lamping DL, Pease CT, Chakravarty K, Silverman B, Choy EH, Scott DG, Hazleman BL, Bourke B, Gendi N, Dasgupta B. Clinical outcomes, quality of life, and diagnostic uncertainty in the first year of polymyalgia rheumatica. Arthritis Rheum. 2007 Jun 15;57(5):803-9. doi: 10.1002/art.22777.
- Freedland KE, King AC, Ambrosius WT, Mayo-Wilson E, Mohr DC, Czajkowski SM, Thabane L, Collins LM, Rebok GW, Treweek SP, Cook TD, Edinger JD, Stoney CM, Campo RA, Young-Hyman D, Riley WT; National Institutes of Health Office of Behavioral and Social Sciences Research Expert Panel on Comparator Selection in Behavioral and Social Science Clinical Trials. The selection of comparators for randomized controlled trials of health-related behavioral interventions: recommendations of an NIH expert panel. J Clin Epidemiol. 2019 Jun;110:74-81. doi: 10.1016/j.jclinepi.2019.02.011. Epub 2019 Feb 28.
- Dishman RK, Steinhardt M. Reliability and concurrent validity for a 7-d re-call of physical activity in college students. Med Sci Sports Exerc. 1988 Feb;20(1):14-25. doi: 10.1249/00005768-198802000-00003.
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 (Estimé)
15 août 2026
Achèvement primaire (Estimé)
31 mars 2027
Achèvement de l'étude (Estimé)
31 mars 2027
Dates d'inscription aux études
Première soumission
24 juillet 2026
Première soumission répondant aux critères de contrôle qualité
4 août 2026
Première publication (Réel)
6 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 202602100
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
This is a feasibility study with only 20 planned participants with limited budget.
There is insufficient support for personnel required to prepare the data for sharing purposes.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .