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

NCT07749547 | Not Yet Recruiting

• 1 other identifier: 202602100
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Polymyalgia Rheumatica (PMR)

Keywords

rehabilitation; physical therapy

Outcome Measures

Primary Outcomes (2)

• Number of potential participants accessed.

  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

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

  7 months

Secondary Outcomes (4)

• 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

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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

Other: Usual Care

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.

Behavioral: Movement Pattern Training (MoveTrain)

Interventions

Movement Pattern Training (MoveTrain) BEHAVIORAL

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 will be documented * Patients are encouraged to use modified motion during daily and physical activities * Based on patient performance, activity difficulty is progressed by increasing repetitions performed or increasing load or speed

Movement Pattern Training (MoveTrain)

Usual Care OTHER

* 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

Usual Care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Publications (12)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 17530680 BACKGROUND

• 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.

  PMID: 24609605 BACKGROUND

• 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.

  PMID: 30826377 BACKGROUND

• 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.

  PMID: 3343912 BACKGROUND

MeSH Terms

Conditions

Polymyalgia Rheumatica

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Marcie Harris-Hayes, DPT, MSCI

CONTACT

314-286-1435; harrisma@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design is a feasibility randomized clinical trial to assess our ability to complete a larger clinical trial to compare movement pattern training (personalized rehabilitation) compared to usual care.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share