Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica
2026年8月4日 更新者: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.
研究概览
研究类型
介入性
注册 (估计的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Marcie Harris-Hayes, DPT, MSCI
- 电话号码:314-286-1435
- 邮箱:harrisma@wustl.edu
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Usual Care
Patients will be encouraged to complete their treatment as described by their physician.
|
|
|
实验性的: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
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of potential participants accessed.
大体时间: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
大体时间:7 months
|
Percent of eligible participants are willing to be randomized during the study
|
7 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Preliminary estimates of change in polymyalgia rheumatica impact scale (PMR-IS)
大体时间: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
大体时间: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
大体时间: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
大体时间: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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月15日
初级完成 (估计的)
2027年3月31日
研究完成 (估计的)
2027年3月31日
研究注册日期
首次提交
2026年7月24日
首先提交符合 QC 标准的
2026年8月4日
首次发布 (实际的)
2026年8月6日
研究记录更新
最后更新发布 (实际的)
2026年8月6日
上次提交的符合 QC 标准的更新
2026年8月4日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.