Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07173335
Registration number
NCT07173335
Ethics application status
Date submitted
19/08/2025
Date registered
15/09/2025
Date last updated
15/09/2025
Titles & IDs
Public title
Integrated Healthy Lifestyle and Pain Care for People With Musculoskeletal Conditions Living in Rural Areas.
Query!
Scientific 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.
Query!
Secondary ID [1]
0
0
2031735
Query!
Secondary ID [2]
0
0
2024/ETH02857
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
HeLP-R
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal Pain
0
0
Query!
Osteoarthritis
0
0
Query!
Low Back Pain
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Neurological
0
0
0
0
Query!
Other neurological disorders
Query!
Diet and Nutrition
0
0
0
0
Query!
Obesity
Query!
Metabolic and Endocrine
0
0
0
0
Query!
Other metabolic disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
BEHAVIORAL - In-person physiotherapist led integrated healthy lifestyle and pain care
BEHAVIORAL - Virtual multidisciplinary integrated healthy lifestyle and pain care
Active comparator: 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.
Experimental: Virtual multidisciplinary pain and lifestyle care - Multidisciplinary integrated healthy lifestyle and pain care, involving a physiotherapist, dietitian, and psychologist, delivered remotely by virtual care.
BEHAVIORAL: 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.
BEHAVIORAL: 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.
Query!
Intervention code [1]
0
0
BEHAVIORAL
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Pain Impact
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline (enrolment), week 12, 26, 39 and 52.
Query!
Secondary outcome [1]
0
0
Pain Intensity
Query!
Assessment method [1]
0
0
Self-reported (PROMIS -29 subdomain); average pain score in the last 7 days on a 0 to 10 numerical rating scale.
Query!
Timepoint [1]
0
0
Baseline (enrolment), week 12, 26, 39 and 52.
Query!
Secondary outcome [2]
0
0
Physical Function
Query!
Assessment method [2]
0
0
Self-reported; PROMIS -29 subdomain (4 items measured from 1 to 5 in ability to complete, total score 20).
Query!
Timepoint [2]
0
0
Baseline (enrolment), week 12, 26, 39 and 52.
Query!
Secondary outcome [3]
0
0
Depression
Query!
Assessment method [3]
0
0
Self-reported; PROMIS -29 subdomains
Query!
Timepoint [3]
0
0
Baseline (enrolment), week 12, 26, 39 and 52.
Query!
Secondary outcome [4]
0
0
Anxiety
Query!
Assessment method [4]
0
0
Self-reported; PROMIS -29 subdomains
Query!
Timepoint [4]
0
0
Baseline (enrolment), week 12, 26, 39 and 52.
Query!
Secondary outcome [5]
0
0
Sleep disturbance
Query!
Assessment method [5]
0
0
Self-reported; PROMIS -29 subdomain.
Query!
Timepoint [5]
0
0
Baseline (enrolment), week 12, 26, 39 and 52.
Query!
Secondary outcome [6]
0
0
Health-related quality of life
Query!
Assessment method [6]
0
0
Self-reported, European Quality of Life 5 Dimensions 5 Level Questionnaire
Query!
Timepoint [6]
0
0
Baseline (enrolment), week 12, 26, 39 and 52.
Query!
Secondary outcome [7]
0
0
Weight
Query!
Assessment method [7]
0
0
Self-reported weight (kilograms) to the nearest gram.
Query!
Timepoint [7]
0
0
Baseline (enrolment), week 12, 26, 39 and 52.
Query!
Secondary outcome [8]
0
0
Pain self-efficacy
Query!
Assessment method [8]
0
0
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).
Query!
Timepoint [8]
0
0
Baseline (enrolment), week 12, 26, 39 and 52.
Query!
Secondary outcome [9]
0
0
Physical activity levels
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Baseline (enrolment), week 12, 26, 39 and 52.
Query!
Secondary outcome [10]
0
0
Diet quality
Query!
Assessment method [10]
0
0
Self-Reported; Dietary Guidelines Index.
Query!
Timepoint [10]
0
0
Baseline (enrolment), week 12, 26, 39 and 52.
Query!
Secondary outcome [11]
0
0
Smoking status
Query!
Assessment method [11]
0
0
Self-reported; adapted from the NSW Health Population Survey smoking status question (including vaping) and Fagerstrom nicotine dependance question.
Query!
Timepoint [11]
0
0
Baseline (enrolment), week 12, 26, 39 and 52.
Query!
Secondary outcome [12]
0
0
Alcohol Consumption
Query!
Assessment method [12]
0
0
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).
Query!
Timepoint [12]
0
0
Baseline (enrolment), week 12, 26, 39 and 52.
Query!
Secondary outcome [13]
0
0
Pain beliefs
Query!
Assessment method [13]
0
0
Self-reported; Pain Beliefs Questionnaire.
Query!
Timepoint [13]
0
0
Baseline (enrolment), week 12, 26, 39 and 52.
Query!
Secondary outcome [14]
0
0
Adverse events
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
Enrolment until end of treatment, and at week 12, 26, 39 and 52.
Query!
Secondary outcome [15]
0
0
Pain Interference
Query!
Assessment method [15]
0
0
Self-reported; PROMIS -29 subdomain (4 items measured from 1 to 5 for level of interference, total score 20).
Query!
Timepoint [15]
0
0
Baseline (enrolment), week 12, 26, 39 and 52.
Query!
Secondary outcome [16]
0
0
Fatigue
Query!
Assessment method [16]
0
0
Description: Self-reported; PROMIS -29 subdomain (4 items measured from 1 to 5 for feelings of fatigue, total score 20).
Query!
Timepoint [16]
0
0
Baseline (enrolment), week 12, 26, 39 and 52.
Query!
Secondary outcome [17]
0
0
Participation
Query!
Assessment method [17]
0
0
Description: Self-reported; PROMIS -29 subdomain (4 items measured from 1 to 5 in ability to participate, total score 20).
Query!
Timepoint [17]
0
0
Baseline (enrolment), week 12, 26, 39 and 52.
Query!
Secondary outcome [18]
0
0
Cognition
Query!
Assessment method [18]
0
0
Self-reported; PROMIS -29 subdomain (2 items measured from 1 to 5 for level of difficulty, total score 10).
Query!
Timepoint [18]
0
0
Baseline (enrolment), week 12, 26, 39 and 52.
Query!
Eligibility
Key inclusion criteria
Inclusion criteria:
* 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion criteria:
* 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
30/09/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
29/02/2028
Query!
Actual
Query!
Sample size
Target
354
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
University Centre for Rural Health, University of Sydney - Lismore
Query!
Recruitment postcode(s) [1]
0
0
2480 - Lismore
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University of Sydney
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Medical Research Future Fund
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT07173335
Query!
Trial related presentations / 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. 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Christopher Williams, PhD
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+61 1300 965 800
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
IPD will be available beginning 12 months and ending 3 years following the trial's outcomes article publication.
Query!
Available to whom?
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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07173335
Download to PDF