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Effectiveness of the Virtual or In-person Physiotherapist-led Evaluation of Referrals to spine surgeons (VIPER) model of care: a randomised controlled trial

Effectiveness of the Virtual or In-person Physiotherapist-led Evaluation of Referrals to spine surgeons (VIPER) model of care: a randomised controlled trial.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626001067369
Acronym
VIPER Trial
Enrollment
314
Registered
2026-08-28
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-09-07

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

Conditions

None listed

Brief summary

Low back pain affects 4 million Australians and creates considerable health service delivery challenges in Australia. Most guidelines advise that low back pain is best managed in primary care with advice and education to support self-management, and effective physical and psychological therapies. Despite this, referrals to spine surgeons are common. In many cases these patients have not tried effective non-surgical care, and while they wait 1-2 years to see a surgeon, they develop health concerns which are complex and costly to manage. In response to this, we co-designed a physiotherapist-led triage and management model of care in spine surgery clinics that could help patients with 'non-urgent’ conditions receive non-surgical care sooner and those with more complex presentations to see a surgeon sooner (Virtual or In-person Physiotherapist-led Evaluation of Referrals to spine surgeons, VIPER). VIPER was informed by a co-design phase which involved assessing and addressing key stakeholders (i.e., patients and health professionals) needs and empowering them to be partners in designing and evaluating the proposed model of care. We hypothesise that the Virtual or In-person Physiotherapist-led Evaluation of Referrals to spine surgeons (VIPER) model of care will reduce disability at 6-months (primary outcome) compared to usual care (i.e. joining the wait list for an in-person appointment with a surgeon) for patients with non-specific low back pain and/or lumbar spine-related leg pain who are referred to a spine surgeon at public hospitals in New South Wales. We also hypothesise that the proposed model of care will be cost-effective and have strong potential to be implemented Australia-wide as it has been co-designed to be acceptable, user-centred, and feasible within the Australian healthcare context.

Interventions

Participants will receive a comprehensive initial assessment conducted by the VIPER physiotherapist via videoconference or in person (based on patient preference or clinician need such as to conduct a neurological exam in person) which involves taking a thorough patient history, performing a thorough subjective and objective assessment of participants’ condition, and reviewing any imaging reports and previous healthcare use for their condition. Following this assessment, the VIPER physiotherapis

Participants will receive a comprehensive initial assessment conducted by the VIPER physiotherapist via videoconference or in person (based on patient preference or clinician need such as to conduct a neurological exam in person) which involves taking a thorough patient history, performing a thorough subjective and objective assessment of participants’ condition, and reviewing any imaging reports and previous healthcare use for their condition. Following this assessment, the VIPER physiotherapist will triage participants as needing either non-surgical care or an appointment with a surgeon guided by the NSW Agency for Clinical Innovation (ACI)’s 2024 audit indicators for spine surgery. Following the initial assessment and triage decision, the VIPER physiotherapist will inform the relevant spine surgeon about their assessment and triage decisions and provide concise regular updates to the surgeon about participant progress during their episode of care. The VIPER physiotherapist will seek surgeon’s input when unsure about their initial triage decision or management. If the VIPER physiotherapist deems a participant suitable for non-surgical care, participants will be booked for a course of in-person or telehealth physiotherapy and/or referred to other health professionals as required. Physiotherapy management will be guided by the principles recommended in the 2022 Australian Commission on Safety and Quality in Health Care Low Back Pain Clinical Care Standard and the 2023 World Health Organisation Guidelines on Chronic Low Back Pain. The VIPER physiotherapist may choose to refer to other health professionals (e.g. rheumatologist, psychologist) and act in a care coordination capacity if they identify that participants’ have treatment needs beyond the scope of physiotherapy care (e.g., require comprehensive medication review, psychosocial support, diet and weight loss advice). Participants deemed suitable for non-surgical care will be discharged from the hospital if they no longer need to see a surgeon or return to the wait list to see the surgeon for an initial surgical opinion if they are not responding to treatment, based on shared decision making between the participant and the physiotherapist. If the VIPER physiotherapist initially deems a participant as needing to see a surgeon, they will join the wait list for the next available appointment (as per participants in the control group). The VIPER physiotherapist will also notify the surgeon if they identify that participants need an in-person appointment with the surgeon more urgently (e.g., due to progressive neurological signs or symptoms missed on the referral). The initial assessment would usually be a 1 hour appointment. Some examples of what physiotherapy management will be administered are advice, exercise prescription, home exercise program. The treatment recording forms have a list if you need more information. We have suggested the a course of physiotherapy could be trialled for up to 6 months but the frequency and duration of appointments will be at the discretion of the VIPER physiotherapist. Intervention fidelity will be based on: - participants receiving an initial physiotherapy assessment; and - participants being recommended care or given referrals that align with the VIPER physiotherapists triage decision (e.g., physiotherapy care, referral to other healthcare professionals, remain on current trajectory with surgical services). Assessment recording forms will be used to evaluate assessment and initial triage decision, and treatment recording forms will be used to evaluate fidelity and assess if treatment provided was guideline-based. Consistency across sites will be maintained via audits of practice during recruitment to ensure fidelity is of a high standard. For example, fidelity will be assessed for the first 3 patients at each site in the VIPER arm. Following this, random spot checks will be used to monitor fidelity. The VIPER research team will be available to answer any questions from the VIPER physiotherapist about the trial process and forms to be completed. The study duration is one year for each participant.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

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

Eligibility

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

Inclusion criteria

Adult patient (18 years or greater) with non-specific low back pain and/or lumbar spine-related leg pain (e.g. radicular pain, lumbar radiculopathy with leg pain, leg pain due to lumbar spinal stenosis) and new referral (defined as being referred within the last 6 weeks) to a public hospital spine surgeon which is considered ‘non- urgent’ by the surgery clinic and willing to participate and provide follow-up data and able to understand spoken and written English to provide sufficient informed consent.

Exclusion criteria

Suspected serious underlying pathology (e.g., malignancy, fracture, infection) or New referral requiring urgent appointment with a surgeon (e.g. rapidly progressive radiculopathy or upper motor neuron lesion).

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026