An interventional study of In-person physiotherapist led integrated healthy lifestyle and pain care and Virtual multidisciplinary integrated healthy lifestyle and pain care in Musculoskeletal Pain, Osteoarthritis and Low Back Pain, sponsored by University of Sydney. Recruiting at 3 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by University of Sydney · Not applicable, Interventional, and Treatment
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.
One in three Australians experience a musculoskeletal condition, with rural residents experiencing 10% to 30% greater burden. People with musculoskeletal conditions also experience higher rates of chronic health problems and higher prevalence of lifestyle risks (overweight, smoking, physically inactive and poor diet). As many as 75% of people with musculoskeletal conditions have three or more lifestyle risk factors, and those living in rural and remote areas have up to 10% increased prevalence of such risks compared to those living in metropolitan or regional areas. Poorer access to health services for musculoskeletal conditions means patients have higher attendance to emergency departments and increased hospitalisations, which also puts additional strain on tertiary healthcare systems. These factors contribute to a greater burden of musculoskeletal disease in rural populations that is 1.4 times higher than metropolitan populations.
Given the links between musculoskeletal conditions and lifestyle risks, and evidence from meta-analyses, many clinical practice guidelines recommend care for musculoskeletal conditions integrates a focus on lifestyle risks (e.g. weight or smoking). Moreover, surveys of patients with co-existing musculoskeletal conditions and lifestyle risks indicate that most have a preference for integrated care that addresses lifestyle risks. Despite this, less than 25% of such patients receive any support to improve lifestyle. The failure of health services to integrate care for pain and lifestyle risks is a missed opportunity to provide treatment that offers optimal therapeutic benefit for musculoskeletal conditions, supports prevention of chronic diseases, and provides patient-centred care.
A recent trial showed that integrating a healthy lifestyle focus into care for chronic back pain achieved larger improvements in disability, mental health and quality of life, compared to guideline recommended physiotherapy care only (without a lifestyle focus). Participants provided with at least 50% of the lifestyle intervention had large clinically meaningful benefit, suggesting better access to treatment may have large population benefit. Process evaluation of the trial revealed that patients wanted more flexible delivery options to access the intervention, including digital and virtual care options. In response to patient input, about better access to treatment, the HeLP-R trial was designed to compare following two delivery modalities of the program.
MODEL OF CARE:
The model of care being tested across the two delivery modalities includes two core principles to support the integration of healthy lifestyle support into pain care: 1) Learning about pain and its causes; and 2) supporting effective behaviour change for healthy lifestyle.
515 studies on the registry are indexed under Musculoskeletal Pain; 127 are open to participants now.
This study's planned enrollment of 354 is above the median of 70 across 370 interventional studies indexed under Musculoskeletal Pain.
Browse Musculoskeletal Pain studies →University of Sydney is the lead sponsor of 94 studies on the registry; 26 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Physiotherapist-led integrated healthy lifestyle and pain care delivered in-person with referral to telephone-based health coaching.
Behavioral: In-person physiotherapist led integrated healthy lifestyle and pain care
Multidisciplinary integrated healthy lifestyle and pain care, involving a physiotherapist, dietitian, and psychologist, delivered remotely by virtual care.
Behavioral: Virtual multidisciplinary 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.
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.
Pain Impact
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.
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Pain Intensity
Self-reported (PROMIS -29 subdomain); average pain score in the last 7 days on a 0 to 10 numerical rating scale.
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Physical Function
Self-reported; PROMIS -29 subdomain (4 items measured from 1 to 5 in ability to complete, total score 20).
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Depression
Self-reported; PROMIS -29 subdomains
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Anxiety
Self-reported; PROMIS -29 subdomains
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Sleep disturbance
Self-reported; PROMIS -29 subdomain.
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Health-related quality of life
Self-reported, European Quality of Life 5 Dimensions 5 Level Questionnaire
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Weight
Self-reported weight (kilograms) to the nearest gram.
Time frame: Baseline (enrolment), week 12, 26, and 52.
Pain self-efficacy
Self-reported; Pain Self-Efficacy Questionnaire 2. Two item self-efficacy questionnaire how confident you are that you can do certain activities despite the pain (scale 0-6).
Time frame: Baseline (enrolment), week 12, 26, and 52.
Physical activity levels
Self-reported; Global Physical Activity Questionnaire (GPAQ), reported as overall physical activity (MET-mins/week), proportion meeting recommended activity and levels of activity for work, travel and recreation.
Time frame: Baseline (enrolment), week 12, 26, and 52.
Diet quality
Self-Reported; Dietary Guidelines Index.
Time frame: Baseline (enrolment), week 12, 26, and 52.
Smoking status
Self-reported; adapted from the NSW Health Population Survey smoking status question (including vaping) and Fagerstrom nicotine dependance question.
Time frame: Baseline (enrolment), week 12, 26, and 52.
Alcohol Consumption
Self-reported; Alcohol Use Disorders Identification Test-Concise (AUDIT-C scored 0-12). Reported as a continuous use score and the proportion with risky alcohol consumption (≥4 for men and ≥3 for women).
Time frame: Baseline (enrolment), week 12, 26, and 52.
Pain beliefs
Self-reported; Pain Beliefs Questionnaire.
Time frame: Baseline (enrolment), week 12, 26, and 52.
Adverse events
Self-reported; "Since the last time we spoke to you have you had any new medical conditions or an exacerbation of another existing condition?" Clinical administrative data collected at all participant consultations.
Time frame: Enrolment until end of treatment, and at week 12, 26, 39 and 52.
Pain Interference
Self-reported; PROMIS -29 subdomain (4 items measured from 1 to 5 for level of interference, total score 20).
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Fatigue
Description: Self-reported; PROMIS -29 subdomain (4 items measured from 1 to 5 for feelings of fatigue, total score 20).
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Participation
Description: Self-reported; PROMIS -29 subdomain (4 items measured from 1 to 5 in ability to participate, total score 20).
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Cognition
Self-reported; PROMIS -29 subdomain (2 items measured from 1 to 5 for level of difficulty, total score 10).
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Fidelity
Process outcome: treatment protocol checklist completed using clinical administrative data and summaries of treatment provided.
Time frame: Enrolment until end of treatment at 26 weeks
Perceived importance
Mediator: Self-reported; 3 items (0-10, numerical rating scale) on perceived importance and benefits of healthy lifestyle change.
Time frame: Baseline (enrolment), week 12, 26.
Patient Reported Experience Measures
Process outcome: Self-reported; 7 or 10 item (group dependant) Patient Reported Experience Measures Outpatient Questionnaire.
Time frame: Week 12
Treatment Engagement (consultations)
Process outcome: Number of consultations attended by a participant and resources provide, detailed in clinical administrative logs, completed by a treating clinicians.
Time frame: Enrolment until end of treatment at Week 26.
Treatment Engagement (telephone services)
Process outcome: Self-reported number of calls completed by a participant with telephone support services, if referred.
Time frame: Week 26.
Work absenteeism and presenteeism
Economic outcome: Self-reported; number of days off paid work, and days spent at work with reduced productivity in the last 3 months.
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Healthcare utilization
Economic outcome: Self-reported; type and number of encounters of health care services and carer support services utilised for back, knee or hip pain, over the last 3 months reported in a participant itemised diary.
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Medication use
Economic outcome: Self-reported; name and dose of medicines used for back, knee or hip pain, over the last 3 months reported in a participant itemised diary.
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Intervention cost
Economics outcome: Intervention delivery costs estimated with clinical administrative captured at clinical encounters and patient reported usage of services, and costed with published standardised rates for clinician time, resources and external services.
Time frame: Enrolment until end of treatment at 26 weeks
Plan to share: Yes — Deidentified individual participant data and data dictionaries will be available for sharing beginning 12 months and ending 3 years following the trial's outcomes article publication. Proposals for data should be directed to the Principal Investigator Associate Professor Christopher Williams, and to gain access requestors will need to sign a data access agreement. Investigators proposed use of the data must also be approved by an independent review committee. Study protocols, statistical analyses plans, and primary and secondary analyses data will be publicly available in open access peer reviewed journal articles or on open science framework.
Supporting information: Study protocol, Statistical analysis plan
Time frame: IPD will be available beginning 12 months and ending 3 years following the trial's outcomes article publication.
Access criteria: Researchers can request access to the IPD on request, supporting information will be available in open access peer reviewed journal articles or on open science framework.
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