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临床试验/NCT07749547
NCT07749547尚未招募不适用

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

Washington University School of Medicine0 个研究点目标入组 20 人开始时间: 2026年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
Percent of eligible participants who were willing to be randomized

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Usual Care

Active Comparator

Patients will be encouraged to complete their treatment as described by their physician.

干预措施: Usual Care (Other)

Movement Pattern Training (MoveTrain)

Experimental

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.

干预措施: Movement Pattern Training (MoveTrain) (Behavioral)

结局指标

主要结局

Percent of eligible participants who were willing to be randomized

时间窗: 7 months

Percent of eligible participants are willing to be randomized during the study

Number of potential participants accessed.

时间窗: 7 months

The total number of people with Polymyalgia rheumatica (PMR) who were recruited each week

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

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