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

Not Applicable

Not yet recruiting

• Conditions: Musculoskeletal Pain; Osteoarthritis; Low Back Pain

• Registration Number: NCT07173335
• Lead Sponsor: University of Sydney

Brief 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.

Detailed Description

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.

* An in-person physiotherapist-led model and referral to a telephone-based health coaching. This intervention aligns with how physiotherapist care is normally delivered in outpatient settings.

* A multidisciplinary model delivered remotely by virtual care, including physiotherapy, dietitian, psychology with additional smoking cessation or alcohol counselling, based on patient health needs. This intervention aligns with feedback from patients and clinicians to provide comprehensive yet flexible care.

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.

* 'Learning about pain' is supported in clinical consultations and with education resources. Learning about pain is for clinicians and participants. Clinicians aim to learn about the participant's journey, their pain history and understanding and beliefs about pain. For participants, learning about pain aims to create conceptual change about the causes of pain, provide reassurance about the safety of movement, introduce lifestyle as a potential influence of musculoskeletal pain, and develop motivation to undertake self-management plan focussed on appropriate lifestyle targets. Clinical consultations use principles of motivational interviewing and psychoeducation and are guided by program specific communication aids. Educational resources (electronic and hard copy) are provided to participants in interactive and reflective formats to reinforce learning concepts.

* 'Supporting effective behaviour change' involves co-development of a tailored pain and lifestyle management plan. Clinicians assess the participants stage of change for nominated lifestyle risks (weight, diet, physical activity, smoking, sleep, alcohol) and use behaviour change techniques such as goal setting, action planning, problem solving and monitoring throughout clinical consultations. As appropriate, participants are offered referral to relevant lifestyle risk reduction services which provide telephone-based healthy lifestyle coaching or smoking cessation counselling over 6 calls (each).

Study Timeline

• Study First Submitted: 2025-08-19
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-15
• Last Update Posted: 2025-09-15
• Study Start: 2025-09-30
• Primary Completion: 2028-02-29
• Study Completion: 2028-02-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 354

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Pain Intensity	Baseline (enrolment), week 12, 26, 39 and 52.	Self-reported (PROMIS -29 subdomain); average pain score in the last 7 days on a 0 to 10 numerical rating scale.
Physical Function	Baseline (enrolment), week 12, 26, 39 and 52.	Self-reported; PROMIS -29 subdomain (4 items measured from 1 to 5 in ability to complete, total score 20).
Depression	Baseline (enrolment), week 12, 26, 39 and 52.	Self-reported; PROMIS -29 subdomains
Anxiety	Baseline (enrolment), week 12, 26, 39 and 52.	Self-reported; PROMIS -29 subdomains
Sleep disturbance	Baseline (enrolment), week 12, 26, 39 and 52.	Self-reported; PROMIS -29 subdomain.
Health-related quality of life	Baseline (enrolment), week 12, 26, 39 and 52.	Self-reported, European Quality of Life 5 Dimensions 5 Level Questionnaire
Weight	Baseline (enrolment), week 12, 26, 39 and 52.	Self-reported weight (kilograms) to the nearest gram.
Pain self-efficacy	Baseline (enrolment), week 12, 26, 39 and 52.	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).
Physical activity levels	Baseline (enrolment), week 12, 26, 39 and 52.	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.
Diet quality	Baseline (enrolment), week 12, 26, 39 and 52.	Self-Reported; Dietary Guidelines Index.
Smoking status	Baseline (enrolment), week 12, 26, 39 and 52.	Self-reported; adapted from the NSW Health Population Survey smoking status question (including vaping) and Fagerstrom nicotine dependance question.
Alcohol Consumption	Baseline (enrolment), week 12, 26, 39 and 52.	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).
Pain beliefs	Baseline (enrolment), week 12, 26, 39 and 52.	Self-reported; Pain Beliefs Questionnaire.
Adverse events	Enrolment until end of treatment, and at week 12, 26, 39 and 52.	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.
Pain Interference	Baseline (enrolment), week 12, 26, 39 and 52.	Self-reported; PROMIS -29 subdomain (4 items measured from 1 to 5 for level of interference, total score 20).
Fatigue	Baseline (enrolment), week 12, 26, 39 and 52.	Description: Self-reported; PROMIS -29 subdomain (4 items measured from 1 to 5 for feelings of fatigue, total score 20).
Participation	Baseline (enrolment), week 12, 26, 39 and 52.	Description: Self-reported; PROMIS -29 subdomain (4 items measured from 1 to 5 in ability to participate, total score 20).
Cognition	Baseline (enrolment), week 12, 26, 39 and 52.	Self-reported; PROMIS -29 subdomain (2 items measured from 1 to 5 for level of difficulty, total score 10).

Trial Locations

Locations (1)

University Centre for Rural Health, University of Sydney; 🇦🇺 Lismore, New South Wales, Australia