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Stratified care integrated with eHealth for low back pain: a feasibility randomised controlled trial

The feasibility of delivering and evaluating stratified care integrated with eHealth (‘Rapid Virtual Stratified Care’) for patients with low back pain: a randomised controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001104842
Enrollment
40
Registered
2021-08-18
Start date
2022-05-07
Completion date
2024-03-19
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Long waiting times stop many Australians with musculoskeletal pain (eg. back pain) from receiving effective, affordable treatment, particularly the 55% of Australians who do not have private health insurance. Long waiting times can delay recovery and lead to worse symptoms that become difficult to treat and require more intensive, costly clinic-based treatment. In many public hospitals, patients with musculoskeletal pain are seen in the order they join the waiting list, with little consideration for the severity of their condition. We want to develop and test a new treatment system where patients with less severe musculoskeletal pain are managed using less resources (eg. brief virtual appointments, mobile App exercise programs) and patients with more severe symptoms are provided fast access to clinic-based care. The aims of this project are to: i) determine the feasibility of delivering this treatment system (‘Rapid Virtual Care’) to patients in a physiotherapy/rheumatology clinic in a public hospital; and ii) determine the feasibility of conducting a larger research study in multiple public hospital clinics that will determine whether this treatment system (‘Rapid Virtual Care’) reduces waiting times Results from the larger research project will determine whether Rapid Virtual Care can reduce treatment waiting times for people with severe musculoskeletal pain while not compromising outcomes for patients with less severe symptoms who are provide less care.

Interventions

Rapid virtual stratified care group: The mode and type of care will be matched to the patient’s risk of persistent disabling pain, categorized as low, medium or high (using the Keele STarT MSK Tool), as well as the presence of worrisome radicular symptoms. • Patients at low risk of persistent pain (Keele STarT MSK score 0–4) will receive a telephone call (~10 minutes) by a Rheumatology Advanced trainee. Patients without suspected serious spinal pathology or worrisome radicular symptoms (as a

Rapid virtual stratified care group: The mode and type of care will be matched to the patient’s risk of persistent disabling pain, categorized as low, medium or high (using the Keele STarT MSK Tool), as well as the presence of worrisome radicular symptoms. • Patients at low risk of persistent pain (Keele STarT MSK score 0–4) will receive a telephone call (~10 minutes) by a Rheumatology Advanced trainee. Patients without suspected serious spinal pathology or worrisome radicular symptoms (as assessed by a study-specific screening questionnaire, score of 3 or more) will be told their condition does not warrant further formal treatment as they have a good prognosis and their back pain will likely resolve on its own. They will be encouraged to gradually increase their daily walking as pain permits, temporarily modify their activities to manage their symptoms, take paracetamol if required, and receive written educational material on low back pain from the Agency for Clinical Innovation. Participants will be instructed to call back if their condition does not improve over the next 6 weeks. The Rheumatology Advanced trainee will then decide whether the participants needs to be managed according to a different risk sub-group. • Patients at medium risk of persistent pain (score 5–8) will receive a telephone call (~10 minutes) by a Rheumatology Advanced trainee. Patients without suspected serious spinal pathology or worrisome radicular symptoms (as assessed by a study-specific screening questionnaire, score of 3 or more) will be offered a virtual consultation with a physiotherapist. The physiotherapist will provide advice and education to support self-management (e.g. advice to exercise, modify activities, lose weight, or take simple pain medications if needed), and an App-based exercise program (PhysiTrack) if necessary. PhysiTrack has over 5,000 physiotherapy exercises and over 1,000 specific to low back pain. The physiotherapist will tailor the exercise program to patients’ activity goals and level of function and be free to select any type (e.g. flexibility, aerobic, resistance) and dosage of exercise. The physiotherapist will have the option to print out the exercises for the patient if the patients is not comfortable using the app. The duration and number of virtual physiotherapy consultations will be at the discretion of the treating physiotherapists but limited to a maximum of 12 appointments (max duration 30 minutes per appointment) over 6 months • Patients at high risk of persistent pain (9–12) will receive a telephone call (~10 minutes) by a Rheumatology Advanced trainee. Patients without suspected serious spinal pathology or worrisome radicular symptoms (as assessed by a study-specific screening questionnaire, score of 3 or more) will be offered a virtual consultation with a physiotherapist. The physiotherapist will provide advice and education to support self-management (e.g. advice to exercise, modify activities, lose weight, or take simple pain medications if needed), and may provide interventions to address psychological barriers to recovery (e.g. Cognitive Behavioural Therapy, graded exposure), and an App-based exercise program (PhysiTrack - as per the medium risk sub-group). The physiotherapist will also direct participants to complete an online self-directed pain education program developed by the Agency for Clinical Innovation. The program (Pain Management: For Everyone https://www.aci.health.nsw.gov.au/chronic-pain/for-everyone) is publicly available and includes seven modules: 1. Introduction to pain (6:47 minutes) 2. Getting help from your healthcare team (5:56 minutes) 3. Pain and physical activity (12:43 minutes) 4. Pain: Lifestyle and nutrition (8:41 minutes) 5. Pain and role of medications (9:57 minutes) 6. Pain and thoughts (10:27 minutes) 7. Pain and sleep (11:08 minutes) Patients will be encouraged to go through the program at their own pace and bring any questions to their next virtual consultation if necessary. The duration and number of virtual physiotherapy consultations will be at the discretion of the treating physiotherapists but limited to a maximum of 12 appointments (max duration 30 minutes per appointment) over 6 months. Patients can also be referred to see a psychologist if the Rheumatology Advanced trainee and physiotherapist agree it would be valuable. The duration and number of psychology appointments will be up to the treating psychologist (with no restrictions imposed by our study). • Patients with worrisome radicular symptoms (as assessed by a study-specific screening questionnaire, score of 3 or more) will be prioritised for a face-to-face consultation with a rheumatologist in the Back Clinic (~30 minutes). If necessary, the rheumatologist will refer patients to receive a course of face-to-face physiotherapy. Patients at high-risk of persistent pain will receive interventions to address psychological barriers to recovery (e.g. Cognitive Behavioural Therapy, graded exposure) and can be referred to see a psychologist if necessary. The duration and number of follow-up physiotherapy consultations will be at the discretion of the treating physiotherapists but limited to a maximum of 12 appointments (max duration 1 hour per appointment) over 6 months. The duration and number of psychology appointments will be up to the treating psychologist (with no restrictions imposed by our study). Participants' adherence to the interventions provided by the physiotherapists will not be assesed because the exact management protocol (within each treatment subgroup) is at the discretion of the treating physiotherapist. The PhysiTrack App will not collect exercise adherence data from participants.

Sponsors

Joshua Zadro
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

A person will be eligible to participate if he or she: • is 18 years or over • has LBP (non-specific LBP or radicular LBP/sciatica) • is a new referral to the Back Clinic from primary care (i.e. has not been on the waiting list prior to enrolment) • is willing to participate for up to 6 months and provide follow-up data at 6 weeks and 6 months

Exclusion criteria

A person will be excluded if he or she: • has a suspected serious underlying pathology (e.g. cancer, fracture, infection, inflammatory arthritis, cauda equina syndrome) • is pregnant

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 13, 2026