Integrated Healthy Lifestyle and Pain Care for People With Musculoskeletal Conditions Living in Rural Areas.
NCT ID: NCT07173335
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
354 participants
INTERVENTIONAL
2025-09-30
2028-02-29
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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 pain and lifestyle care
Multidisciplinary integrated healthy lifestyle and pain care, involving a physiotherapist, dietitian, and psychologist, delivered remotely by virtual care.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Medical Research Future Fund
OTHER
University of Sydney
OTHER
Responsible Party
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Locations
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University Centre for Rural Health, University of Sydney
Lismore, New South Wales, Australia
Countries
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Central Contacts
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Facility Contacts
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References
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Robson E, Kamper SJ, Hall A, Lee H, Davidson S, da Silva PV, Gleadhill C, Williams CM; HeLP Trial Working Group. Effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain: statistical analysis plan for a randomised controlled trial. Trials. 2021 Sep 22;22(1):648. doi: 10.1186/s13063-021-05591-0.
Robson EK, Kamper SJ, Davidson S, Viana da Silva P, Williams A, Hodder RK, Lee H, Hall A, Gleadhill C, Williams CM. Healthy Lifestyle Program (HeLP) for low back pain: protocol for a randomised controlled trial. BMJ Open. 2019 Sep 3;9(9):e029290. doi: 10.1136/bmjopen-2019-029290.
Mudd E, Davidson SRE, Kamper SJ, Viana da Silva P, Gleadhill C, Hodder RK, Haskins R, Donald B, Williams CM; Healthy Lifestyle Program (HeLP) for Chronic Low Back Pain Trial working group. Healthy Lifestyle Care vs Guideline-Based Care for Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2453807. doi: 10.1001/jamanetworkopen.2024.53807.
Other Identifiers
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2031735
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024/ETH02857
Identifier Type: -
Identifier Source: org_study_id
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