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

NCT07173335 | Not Yet Recruiting

• 2 other identifiers: 2024/ETH028572031735
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain; Osteoarthritis; Low Back Pain

Keywords

nutrition; smoking; alcohol; osteoarthritis; low back pain; chronic pain; overweight; obesity; physical activity; lifestyle risk factors; sleep; physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (enrolment), week 12, 26, 39 and 52.

Secondary Outcomes (18)

• Pain Intensity

  Baseline (enrolment), week 12, 26, 39 and 52.

• Physical Function

  Baseline (enrolment), week 12, 26, 39 and 52.

• Depression

  Baseline (enrolment), week 12, 26, 39 and 52.

• Anxiety

  Baseline (enrolment), week 12, 26, 39 and 52.

• Sleep disturbance

  Baseline (enrolment), week 12, 26, 39 and 52.

Other Outcomes (9)

• Fidelity

  Enrolment until end of treatment at 26 weeks

• Perceived importance

  Baseline (enrolment), week 12, 26.

• Patient Reported Experience Measures

  Week 12

Study Arms (2)

In-person physiotherapist-led pain and lifestyle care

ACTIVE COMPARATOR

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

Virtual multidisciplinary pain and lifestyle care

EXPERIMENTAL

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

Interventions

In-person physiotherapist led integrated healthy lifestyle and pain care BEHAVIORAL

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.

In-person physiotherapist-led pain and lifestyle care

Virtual multidisciplinary integrated healthy lifestyle and pain care BEHAVIORAL

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.

Virtual multidisciplinary pain and lifestyle care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sydney: lead
• Medical Research Future Fund: collaborator

Study Sites (1)

University Centre for Rural Health, University of Sydney

Lismore, New South Wales, 2480, Australia

Location

Related Publications (3)

• 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.

  PMID: 34551809 BACKGROUND

• 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.

  PMID: 31481555 BACKGROUND

• 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.

  PMID: 39792385 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Pain; Osteoarthritis; Low Back Pain; Smoking; Chronic Pain; Overweight; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Rheumatic Diseases; Back Pain; Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Central Study Contacts

Christopher Williams, PhD

CONTACT

+61 1300 965 800; c.williams@sydney.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All data will be analysed by an independent statistician blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A parallel group (two arm, 1:1), pragmatic comparative effectiveness, non-inferiority randomised controlled trial.

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 15, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 29, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

AU (1)