Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica

Официальное название

Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica: a Feasibility Randomized Clinical Trial

Обзор

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.

Вмешательства

• Поведенческое Movement Pattern Training (MoveTrain)
  6 individualized treatment sessions over 10 weeks * Motivational interviewing to determine personal goals and strengthen motivation and commitment to change * Activity-specific training to practice modified motion during patient-specific tasks, defined as activities reported by each patient as pain-provoking * Home exercise program 3 times/week consisting of activities or exercises assigned in the supervised sessions * Patient's independence and adherence in performing home exercise program wil
• Другое Usual Care
  * Basic education about polymyalgia rheumatica, benefits of physical activity * Patients will be encouraged to participate in physical activity as tolerated * Medication as prescribed by their physician

Первичные конечные точки

• Number of potential participants accessed. [Срок оценки: 7 months]
• Percent of eligible participants who were willing to be randomized [Срок оценки: 7 months]

Вторичные конечные точки (4)

• Preliminary estimates of change in polymyalgia rheumatica impact scale (PMR-IS) [Срок оценки: From enrollment to the end of treatment at 10 weeks]
• Preliminary estimates of change in physical activity [Срок оценки: From enrollment to the end of treatment at 10 weeks]
• Preliminary estimates of change in cumulative glucocorticoid dose [Срок оценки: From enrollment to the end of treatment at 10 weeks]
• Preliminary estimates of change in muscle strength [Срок оценки: From enrollment to the end of treatment at 10 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 32518674
• 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. PMID 28765246
• 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. PMID 40619692
• 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. PMID 27117727
• 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. PMID 35639659
• 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. PMID 25638304
• 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. PMID 6507425
• 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. PMID 27707738

Идентификаторы

NCT: NCT07749547 · 202602100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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