Integrated healthy lifestyle and pain care for people with musculoskeletal conditions in rural areas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial compares two formats of a lifestyle-focused pain management program: in-person physiotherapist-led care versus a virtual, multidisciplinary approach. Eligible adults in rural and regional New South Wales with chronic musculoskeletal pain and lifestyle risks are randomized 1:1 to either arm and will receive up to 10 consultations over six months. Both arms follow integrated strategies addressing pain with lifestyle risk factors such as diet, activity, smoking, sleep, and weight. Randomization is concealed via an electronic central service, and recruitment occurs from hospital outpatient services or via social media. The study builds on evidence that lifestyle factors worsen musculoskeletal conditions and that integrated care is preferred but underutilized in rural settings.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mid North Coast Local Health District
  Coffs Harbour, New South Wales, Australia Recruiting
• Northern NSW Local Health District
  Lismore, New South Wales, Australia Recruiting
• University Centre for Rural Health, University of Sydney
  Lismore, New South Wales, Australia Not yet recruiting

Study contacts

• Study coordinator: Christopher Williams, PhD
• Email: c.williams@sydney.edu.au
• Phone: +61 1300 965 800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.