- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07749547
Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica
August 4, 2026 updated by: 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marcie Harris-Hayes, DPT, MSCI
- Phone Number: 314-286-1435
- Email: harrisma@wustl.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Usual Care
Patients will be encouraged to complete their treatment as described by their physician.
|
|
|
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.
|
6 individualized treatment sessions over 10 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of potential participants accessed.
Time Frame: 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
Time Frame: 7 months
|
Percent of eligible participants are willing to be randomized during the study
|
7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preliminary estimates of change in polymyalgia rheumatica impact scale (PMR-IS)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 15, 2026
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Study Registration Dates
First Submitted
July 24, 2026
First Submitted That Met QC Criteria
August 4, 2026
First Posted (Actual)
August 6, 2026
Study Record Updates
Last Update Posted (Actual)
August 6, 2026
Last Update Submitted That Met QC Criteria
August 4, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202602100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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