Musculoskeletal PainHeLP-RNCT07173335
Integrated Healthy Lifestyle and Pain Care for People With Musculoskeletal Conditions Living in Rural Areas.
A study testing In-person physiotherapist led integrated healthy lifestyle and pain care and Virtual multidisciplinary integrated healthy lifestyle and pain care in people with Musculoskeletal Pain and Osteoarthritis, run by University of Sydney at 3 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain, Osteoarthritis, Low Back Pain
- What is being tested?
- In-person physiotherapist led integrated healthy lifestyle and pain care and Virtual multidisciplinary integrated healthy lifestyle and pain care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 3 sitesAustralia
- Study dates
- 17 Sep 2025to 29 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Recruiting
Mid North Coast Local Health District
Coffs Harbour, New South Wales, 2450
Lisa Abraham, Master of Clinical Psychology, 1300 965 800, ucrh.trials@sydney.edu.au
Christopher Williams, PhD
- Recruiting
Northern NSW Local Health District
Lismore, New South Wales, 2480
Peter Kelly, Master of Physiotherapy, 1300 965 800, ucrh.trials@sydney.edu.au
Amanda Tutty, BAppSci
- Not yet recruiting
University Centre for Rural Health, University of Sydney
Lismore, New South Wales, 2480
Christopher M Williams, PhD, +61 1300 965 800, ucrh.trials@sydney.edu.au
About this study
Official title: Comparison of In-person and Virtual Delivery of Healthy Lifestyle Focused Care for People With Chronic Musculoskeletal Conditions Living in Rural Areas: a Non-interiority Randomised Trial.
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.
Read more
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.
Read the 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).
- Conditions
- Musculoskeletal Pain, Osteoarthritis, Low Back Pain
- Being tested
- In-person physiotherapist led integrated healthy lifestyle and pain care, Virtual multidisciplinary integrated healthy lifestyle and pain care
- Keywords
- nutrition, smoking, alcohol, osteoarthritis, low back pain, chronic pain, overweight, obesity, physical activity, lifestyle risk factors, sleep, physiotherapy
- Medical subject headings
- Musculoskeletal Pain, Osteoarthritis, Low Back Pain, Smoking, Chronic Pain, Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person physiotherapist led integrated healthy lifestyle and pain careBehavioural
Participants allocated to in-person intervention will be offered:
- Up to four in-person physiotherapist consultations (up to one hour in duration) over 12 weeks (weeks 1, 3, 6, and 12);
- 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;
- 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 careBehavioural
Participants allocated to the virtual multidisciplinary intervention will receive:
- 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;
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Virtual multidisciplinary integrated healthy lifestyle and pain care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (enrolment), week 12, 26, 39 and 52.
Secondary outcomes (18)
Pain Intensity
Self-reported (PROMIS -29 subdomain); average pain score in the last 7 days on a 0 to 10 numerical rating scale.
Measured: 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).
Measured: Baseline (enrolment), week 12, 26, 39 and 52.
Depression
Self-reported; PROMIS -29 subdomains
Measured: Baseline (enrolment), week 12, 26, 39 and 52.
Anxiety
Self-reported; PROMIS -29 subdomains
Measured: Baseline (enrolment), week 12, 26, 39 and 52.
Sleep disturbance
Self-reported; PROMIS -29 subdomain.
Measured: Baseline (enrolment), week 12, 26, 39 and 52.
Health-related quality of life
Self-reported, European Quality of Life 5 Dimensions 5 Level Questionnaire
Measured: Baseline (enrolment), week 12, 26, 39 and 52.
Weight
Self-reported weight (kilograms) to the nearest gram.
Measured: 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).
Measured: 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.
Measured: Baseline (enrolment), week 12, 26, and 52.
Diet quality
Self-Reported; Dietary Guidelines Index.
Measured: 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.
Measured: 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).
Measured: Baseline (enrolment), week 12, 26, and 52.
Pain beliefs
Self-reported; Pain Beliefs Questionnaire.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline (enrolment), week 12, 26, 39 and 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start17 Sep 2025
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel group (two arm, 1:1), pragmatic comparative effectiveness, non-inferiority randomised controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Future Fund
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173335
- Sponsor's protocol ID
- 2024/ETH02857
- Other IDs
- 2031735
- Acronym
- HeLP-R
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 34551809Robson 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.
PubMed 31481555Mudd 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.
PubMed 39792385
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of In-person and Virtual Delivery of Healthy Lifestyle Focused Care for People With Chronic Musculoskeletal Conditions Living in Rural Areas: a Non-interiority Randomised Trial.
- ClinicalTrials.gov ID
- NCT07173335
- Acronym / sponsor ID
- HeLP-R / 2024/ETH02857
- Conditions
- Musculoskeletal Pain, Osteoarthritis, Low Back Pain
- Keywords
- nutrition, smoking, alcohol, osteoarthritis, low back pain, chronic pain, overweight, obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- Medical Research Future Fund
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel group (two arm, 1:1), pragmatic comparative effectiveness, non-inferiority randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| In-person physiotherapist-led pain and lifestyle care | Active comparator | Behavioral: In-person physiotherapist led integrated healthy lifestyle and pain carePhysiotherapist-led integrated healthy lifestyle and pain care delivered in-person with referral to telephone-based health coaching. |
| Virtual multidisciplinary pain and lifestyle care | Experimental | Behavioral: Virtual multidisciplinary integrated healthy lifestyle and pain careMultidisciplinary integrated healthy lifestyle and pain care, involving a physiotherapist, dietitian, and psychologist, delivered remotely by virtual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-person physiotherapist led integrated healthy lifestyle and pain careParticipants 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. | Behavioural | In-person physiotherapist-led pain and lifestyle care |
| Virtual multidisciplinary integrated healthy lifestyle and pain careParticipants 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. | Behavioural | Virtual multidisciplinary pain and lifestyle care |
Primary outcome
Pain Impact
Time frame: 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.
18 secondary outcomes
Pain Intensity
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Physical Function
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Depression
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Anxiety
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Sleep disturbance
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Health-related quality of life
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Weight
Time frame: Baseline (enrolment), week 12, 26, and 52.
Pain self-efficacy
Time frame: Baseline (enrolment), week 12, 26, and 52.
Physical activity levels
Time frame: Baseline (enrolment), week 12, 26, and 52.
Diet quality
Time frame: Baseline (enrolment), week 12, 26, and 52.
Smoking status
Time frame: Baseline (enrolment), week 12, 26, and 52.
Alcohol Consumption
Time frame: Baseline (enrolment), week 12, 26, and 52.
Pain beliefs
Time frame: Baseline (enrolment), week 12, 26, and 52.
Adverse events
Time frame: Enrolment until end of treatment, and at week 12, 26, 39 and 52.
Pain Interference
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Fatigue
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Participation
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Cognition
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Background: PubMed 34551809Robson 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.
- Background: PubMed 31481555Robson 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.
- Background: PubMed 39792385Mudd 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person physiotherapist led integrated healthy lifestyle and pain care and Virtual multidisciplinary integrated healthy lifestyle and pain care in people with Musculoskeletal Pain and Osteoarthritis, run by University of Sydney at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Williams, PhD (+61 1300 965 800, c.williams@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Impact (time frame: Baseline (enrolment), week 12, 26, 39 and 52.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07173335, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.