Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica
4 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Marcie Harris-Hayes, DPT, MSCI
- Número de teléfono: 314-286-1435
- Correo electrónico: harrisma@wustl.edu
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Usual Care
Patients will be encouraged to complete their treatment as described by their physician.
|
|
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Experimental: 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.
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6 individualized treatment sessions over 10 weeks
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of potential participants accessed.
Periodo de tiempo: 7 months
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The total number of people with Polymyalgia rheumatica (PMR) who were recruited each week
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7 months
|
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Percent of eligible participants who were willing to be randomized
Periodo de tiempo: 7 months
|
Percent of eligible participants are willing to be randomized during the study
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7 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Preliminary estimates of change in polymyalgia rheumatica impact scale (PMR-IS)
Periodo de tiempo: 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.
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From enrollment to the end of treatment at 10 weeks
|
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Preliminary estimates of change in physical activity
Periodo de tiempo: 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
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From enrollment to the end of treatment at 10 weeks
|
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Preliminary estimates of change in cumulative glucocorticoid dose
Periodo de tiempo: From enrollment to the end of treatment at 10 weeks
|
Change in cumulative glucocorticoid dose assessed by patient's self-report logs
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From enrollment to the end of treatment at 10 weeks
|
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Preliminary estimates of change in muscle strength
Periodo de tiempo: From enrollment to the end of treatment at 10 weeks
|
change in muscle strength of the hips and shoulders, assessed using a hand dynamometer
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From enrollment to the end of treatment at 10 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de agosto de 2026
Finalización primaria (Estimado)
31 de marzo de 2027
Finalización del estudio (Estimado)
31 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
24 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de agosto de 2026
Publicado por primera vez (Actual)
6 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 202602100
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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