University Centre for Rural Health, University of Sydney
Lismore, New South Wales, 2480, Australia
NCT Number: NCT07173335
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Lismore, New South Wales, 2480, Australia
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Self-reported; PROMIS -29 subdomains
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Self-reported; PROMIS -29 subdomains
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Self-reported; PROMIS -29 subdomain.
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Self-reported, European Quality of Life 5 Dimensions 5 Level Questionnaire
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Self-reported weight (kilograms) to the nearest gram.
Time frame: 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).
Time frame: 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.
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Self-Reported; Dietary Guidelines Index.
Time frame: 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.
Time frame: 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).
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Self-reported; Pain Beliefs Questionnaire.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Enrolment until end of treatment at 26 weeks
Process outcome: treatment protocol checklist completed using clinical administrative data and summaries of treatment provided.
Time frame: Baseline (enrolment), week 12, 26.
Mediator:
Self-reported; 3 items (0-10, numerical rating scale) on perceived importance and benefits of healthy lifestyle change.
Time frame: Week 12
Process outcome: Self-reported; 7 or 10 item (group dependant) Patient Reported Experience Measures Outpatient Questionnaire.
Time frame: Enrolment until end of treatment at Week 26.
Process outcome: Number of consultations attended by a participant and resources provide, detailed in clinical administrative logs, completed by a treating clinicians.
Time frame: Week 26.
Process outcome: Self-reported number of calls completed by a participant with telephone support services, if referred.
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Economic outcome: Self-reported; number of days off paid work, and days spent at work with reduced productivity in the last 3 months.
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Economic outcome: Self-reported; type and number of encounters of health care services and carer support services utilised for back, knee or hip pain, over the last 3 months reported in a participant itemised diary.
Time frame: Baseline (enrolment), week 12, 26, 39 and 52.
Economic outcome: Self-reported; name and dose of medicines used for back, knee or hip pain, over the last 3 months reported in a participant itemised diary.
Time frame: Enrolment until end of treatment at 26 weeks
Economics outcome: Intervention delivery costs estimated with clinical administrative captured at clinical encounters and patient reported usage of services, and costed with published standardised rates for clinician time, resources and external services.
Contact information is provided by the study sponsor or research team.
University of Sydney
Other
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.
Acronym: HeLP-R
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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