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

NCT07173335 · tracked via the Priya Life Science Australia tracker

Sponsor

University of Sydney

Phase

Not applicable

Started

2025-09-17

Last updated

2026-09-18

Condition(s) studied

Musculoskeletal PainOsteoarthritisLow Back Pain

Investigational drug(s) / intervention(s)

In-person physiotherapist led integrated healthy lifestyle and pain careVirtual multidisciplinary integrated healthy lifestyle and pain care

In-person physiotherapist led integrated healthy lifestyle and pain care: 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: 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 summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion criteria: * Age 18 years and over, with one or more of the following chronic musculoskeletal conditions (pain or disability due to knee or hip, or non-specific low back pain) present for more than three months; * Average pain intensity over the last week of 3 or more on a 11-point numerical rating scale OR pain interference of at least 'somewhat' (3 out 5) on item 27 of the PROMIS 29; * At least one of the following lifestyle risk factors: Body Mass Index of greater than 25kg/m2, less than 30mins of physical activity on five or more days of the week, current smoker or vaper, consumes less than two serves of fruits or five serves of vegetables per day, drinks more than 10 standard drinks in a week, or more than 4 standard drinks on any one day, or 'poor' or 'very poor' sleep quality for item 6 of the Pittsburg Sleep Quality Index. Exclusion criteria: * Receiving healthcare for ALL eligible lifestyle risks; * Had bariatric surgery in the last 12 months or have planned bariatric surgery in the next 6 months; * Have planned orthopaedic surgery in the next 6 months; * Cannot actively or safely engage in the intervention or study procedures due to a medical comorbidity or constraint (e.g. impaired cognition, unable to use telehealth services, attend appointments, or adapt meals or activity); * Pain due to suspected serious cause, (e.g spinal infection, cancers, fracture, systemic rheumatic disease, cauda equina syndrome, diagnosis of radiculopathy); * Pregnant or planning pregnancy in the next 6 months.

Primary outcome measure(s)

Pain Impact — Baseline (enrolment), week 12, 26, 39 and 52.
Pain Impact is measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29). PROMIS-29 is a validated self-report measure that assesses pain, function, and well-being in physical, mental, and social domains. The Pain Impact Score (range 8-50) uses pain intensity, physical function, and pain interference subdomains.

Trial sites (3)

Facility	City	Region	Status
Mid North Coast Local Health District	Coffs Harbour	New South Wales	Recruiting
Northern NSW Local Health District	Lismore	New South Wales	Recruiting
University Centre for Rural Health, University of Sydney	Lismore	New South Wales	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07173335 on ClinicalTrials.gov ↗ ← All trials in Australia