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Integrated Healthy Lifestyle and Pain Care for People With Musculoskeletal Conditions Living in Rural Areas.

Study acronym: HeLP-R
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Recruitment opened Show 6 more changesShow less
    • Study sites: 1 to 3
    • Start date changed from estimate of Sep 30, 2025 to Sep 17, 2025
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 8 of 18 entries
    • Publications: details revised at 3 of 3 entries
    • Study description expanded, about 4 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Sydney
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This study aims to compare the effects of an in-person physiotherapist-led lifestyle-focused pain care intervention with a virtual multidisciplinary lifestyle-focused pain care intervention on pain impact in people with musculoskeletal conditions and lifestyle risks. Adults residing in rural and regional locations in New South Wales (AUS) with musculoskeletal conditions (low back, knee or hip pain) recruited from hospital outpatient services (physiotherapy, emergency or orthopaedics) or in response to social media advertisements. Eligible consenting participants will be randomised in a 1:1 ratio to receive either in-person physiotherapy lifestyle intervention or the virtual enabled multidisciplinary intervention. Randomisation will be conducted using an electronic central randomisation service to ensure concealment of treatment allocation. Participants in both arms (in-person and virtual care) will have up to 10 consultations over six months and follow similar principles based on the previous Healthy Lifestyle for Pain (HeLP) intervention, but differ in their mode of delivery and access to multidisciplinary care. Participant data will be collected at baseline and weeks 12, 26, 39 and 52. The primary outcome will be Pain Impact measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29). The secondary outcomes will include participant's health behaviors and mediating outcomes, economic outcomes, process outcomes and adverse events.
Trial Details
NCT Number NCT07173335
Lead Sponsor University of Sydney
Collaborators: Medical Research Future Fund
Conditions
(from sponsor)		 Musculoskeletal Pain, Osteoarthritis, Low Back Pain
Related terms Chronic Pain, Low Back Pain, Motor Activity, Musculoskeletal Pain, Obesity, Osteoarthritis, Overweight, Smoking
Enrollment 354 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov