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

Sponsor
University of Sydney
Study ID
NCT07173335
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • In-person physiotherapist led integrated healthy lifestyle and pain care — BEHAVIORAL
    Participants allocated to in-person intervention will be offered: A) Up to four in-person physiotherapist consultations (up to one hour in duration) over 12 weeks (weeks 1, 3, 6, and 12); B) Tailored pain education and healthy lifestyle education and resource bundles, including video content, web resources and interactive tools sent to participants via email or text; C) Referral to telephone-based population wide health behaviour change support services, the NSW Get Healthy Coaching and information service and the Quitline for smokers, by the week 12 consultation (up to 6 telehealth consultations). Total = up to 10 consultations over 6 months.
  • Virtual multidisciplinary integrated healthy lifestyle and pain care — BEHAVIORAL
    Participants allocated to the virtual multidisciplinary intervention will receive: A) 10 consultations over 6 months with a multidisciplinary team, including a minimum 4 with a physiotherapist (week 1, 3, 6, 12) and remainder with a dietitian and/or psychologist, tailored to participants needs. Virtual care consultations may be individual or joint multidisciplinary sessions conducted on standard virtual care platforms used by NSW Health. Consultation will be up to one hour in duration, or use an equivalent total duration with a higher frequency schedule. Where appropriate, participants may be referred to alcohol or smoking cessation support, including individualised virtual or telephone-based counselling with access to nicotine replacement therapy; B) Tailored pain education and healthy lifestyle education and resource bundles, including video content, web resources and interactive tools sent to participants via email or text.

Study Details

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.

Key Dates

First listed
Sep 15, 2025
Start date
Sep 30, 2025
Status verified
Sep 2025
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
354 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: In-person physiotherapist-led pain and lifestyle care
    Physiotherapist-led integrated healthy lifestyle and pain care delivered in-person with referral to telephone-based health coaching.
  • Experimental: Virtual multidisciplinary pain and lifestyle care
    Multidisciplinary integrated healthy lifestyle and pain care, involving a physiotherapist, dietitian, and psychologist, delivered remotely by virtual care.

Primary Outcome Measure

Pain Impact [ Time Frame: Baseline (enrolment), week 12, 26, 39 and 52. ]

Central Contacts

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