Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001198314
Ethics application status
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Approved
Date submitted
Help: Date submitted
4/09/2026
Date registered
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28/09/2026
Date last updated
Help: Date last updated
28/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
28/09/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
PhysioDirect-Australia: A cluster randomised controlled trial evaluating direct access to publicly funded physiotherapy for adults with musculoskeletal pain – effectiveness, cost effectiveness, and implementation.
Scientific title
Funded direct access physiotherapy in addition to usual GP-led care versus usual GP-led care alone for physical health in adults with musculoskeletal pain: the PhysioDirect-Australia non-inferiority cluster randomised controlled trial
Additional trial identifiers [1] 317389 0
APP2040570
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Musculoskeletal pain 342049 0
Condition category
Condition code
Musculoskeletal 338141 338141 0 0
Other muscular and skeletal disorders
Musculoskeletal 339591 339591 0 0
Osteoarthritis
Public Health 339725 339725 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
In clusters randomised to the intervention arm, patients with musculoskeletal pain will continue to access care via usual GP-led and existing referral pathways as described for control clinics. In addition, eligible patients with musculoskeletal pain will be offered access to a funded direct access physiotherapy model of care, allowing patients to consult a participating physiotherapist without requiring a prior GP consultation.
Patients are eligible to access the funded physiotherapy pathway once (for up to four physiotherapy consultations for the presenting episode of care) during the trial period.

The number and frequency of consultations will be determined by usual clinical practice and patient need.

Access pathways (intervention clinics):
Eligible patients may access the funded physiotherapy service via either:
1. Direct self-referral
2. Recommended self-referral (e.g., advised by general practice staff)
3. Referral from a GP within the intervention practice.

In all scenarios, patients must follow the same process to access the funded physiotherapy. They must complete an online or hardcopy self-referral form and contact a participating physiotherapy clinic to book an appointment. The self-referral form captures the referral source by asking patients if they were referred by their GP, and if not how they heard about the service (including self-referral and being 'recommended' by general practice staff).

Awareness of the direct access physiotherapy model of care will be supported by a tailored marketing and awareness campaign developed with each intervention practice. This will inform patients how they can access the funded physiotherapy service. This will commence approximately 8 weeks prior to participant recruitment and disseminated by the practice. Marketing materials (e.g., flyers, posters, campaign messaging) will be developed by the study team in collaboration with the Australian Physiotherapy Association and aligned with existing general practice communication strategies. These materials will describe the availability of funded physiotherapy services only, and will not include information about the research study or requests to participate in research. GPs and administrative staff in intervention practices will receive training on trial procedures and eligibility criteria to enable them to inform patients about the service when appropriate (e.g., during appointment booking).

The self-referral form will be available in hard-copy and online formats, with each form including a study link and QR code providing access to the online version. The form will include information about the funded direct access physiotherapy model of care, a brief explanation of the physiotherapist's role in assessing, diagnosing and managing musculoskeletal conditions, eligibility criteria, information that up to four physiotherapy sessions are covered under the funded pathway, details of participating physiotherapy clinics (including contact details and location), instructions on how to book an appointment, and prompts to seek GP review prior to physiotherapy where potential red flag signs or symptoms are reported.

Prior to site activation, participating general practices and physiotherapy services will complete a mandatory site initiation briefing delivered by the research team. Completed self-referral forms will be submitted in person, via email, or via online submission, and will be stored within a secure, site-specific REDCap project accessible only to authorised physiotherapy clinic staff. Participating physiotherapy services will review self-referral forms prior to consultation, and patients identified as inappropriate for physiotherapy management will be redirected to the most appropriate healthcare provider, with the reason recorded in REDCap and a summary letter sent to the patient's GP. Physiotherapists will send written communication to the patient's GP following the first consultation and where clinically indicated thereafter.

Physiotherapy care will be delivered by registered physiotherapists according to usual, practitioner-defined clinical practice. Physiotherapists may provide assessment, advice, exercise-based management, and other evidence-based interventions as clinically indicated. Patients may continue to receive concurrent GP-led care (e.g. medications, imaging referrals) at the discretion of their treating healthcare providers.

Patients in intervention clinics may access the trial-supported physiotherapy services in accordance with the intervention protocol, while the clinic they are attending remains actively participating in the study (anticipated 12 month period).

The mode (e.g., face-to-face or telehealth) and length of consultation, will not be prescribed by the protocol and will be determined by the treating physiotherapist in accordance with usual practice and participant needs.

No minimum or prescribed number of physiotherapy consultations is required. Intervention uptake and utilisation will be monitored through study records documenting the number and timing of physiotherapy consultations accessed by participants during follow-up.
Intervention code [1] 334180 0
Treatment: Other
Description of the comparator or control
In general practices randomised to the control arm, patients with musculoskeletal pain will continue to be managed according to usual GP-led care. Usual care may include clinical advice, prescription of medications, referral for diagnostic imaging, and referral to other healthcare providers as clinically indicated (e.g. orthopaedic surgeons or physiotherapists).
Patients attending control clinics may still access physiotherapy either via GP referral or through existing direct access pathways; however, any physiotherapy care will occur through usual funding mechanisms (e.g. privately funded services or GP Chronic Disease Management plans). Patients in control clinics will not have access to the funded direct-access physiotherapy pathway provided as part of the intervention.

Care will be delivered by registered general practitioners (GPs) within participating general practices, with any referred services provided by appropriately qualified clinicians as per routine care.

The mode (e.g., face-to-face or telehealth) and length of consultation, will not be prescribed by the protocol and will be determined by the treating GP in accordance with usual practice and participant needs.

GP consultations related to musculoskeletal pain will be monitored through study records, documenting the number and timing of GP consultations accessed by patients while the general practice they are attending remains actively participating in the study (anticipated 12 month period)
Control group
Active

Outcomes
Primary outcome [1] 345534 0
Physical health
Timepoint [1] 345534 0
*Baseline questionnaire, 2, 6, and 12 months post baseline questionnaire. *Baseline questionnaire: completed following the participant's index healthcare consultation for musculoskeletal pain (timing may vary across participants). The primary analysis will estimate the average treatment effect across all follow-up timepoints over 12 months.
Secondary outcome [1] 462054 0
Pain intensity (Average musculoskeletal pain over the last week)
Timepoint [1] 462054 0
Baseline questionnaire, 2, 6 and 12 months after the baseline questionnaire.
Secondary outcome [2] 462057 0
Pain self-efficacy.
Timepoint [2] 462057 0
Baseline questionnaire, 2, 6 and 12 months after the baseline questionnaire.
Secondary outcome [3] 462058 0
Mental health.
Timepoint [3] 462058 0
Baseline questionnaire, 2, 6 and 12 months after the baseline questionnaire.
Secondary outcome [4] 462059 0
Health related quality of life.
Timepoint [4] 462059 0
Baseline questionnaire, 2, 6 and 12 months after the baseline questionnaire.
Secondary outcome [5] 462062 0
Physical activity.
Timepoint [5] 462062 0
Baseline questionnaire, and 2, 6 and 12 months after the baseline questionnaire.
Secondary outcome [6] 462063 0
Global perceived change in musculoskeletal pain or pain-related symptoms since baseline.
Timepoint [6] 462063 0
2, 6 and 12 months after the baseline questionnaire.
Secondary outcome [7] 462090 0
Work absenteeism due to musculoskeletal pain.
Timepoint [7] 462090 0
Baseline questionnaire, and 2, 6 and 12 months after the baseline questionnaire.
Secondary outcome [8] 462098 0
Work presenteeism due to musculoskeletal pain.
Timepoint [8] 462098 0
Baseline questionnaire, and 2, 6 and 12 months after the baseline questionnaire.
Secondary outcome [9] 467433 0
Adverse events.
Timepoint [9] 467433 0
Baseline questionnaire, and 2, 6 and 12 months after the baseline questionnaire.
Secondary outcome [10] 468035 0
Participant Reported Experience Measure
Timepoint [10] 468035 0
Baseline questionnaire only, in relation to the healthcare consultation associated with the model of care accessed.(i.e., evaluating the model of care accessed to begin care)
Secondary outcome [11] 468036 0
Participant-rated overall quality of care received for musculoskeletal pain.
Timepoint [11] 468036 0
Baseline questionnaire only, in relation to the healthcare consultation associated with the model of care accessed. (i.e., evaluating the model of care accessed to begin care)
Secondary outcome [12] 468037 0
Number of musculoskeletal pain related consultations with each health professional type.
Timepoint [12] 468037 0
2, 6 and 12 months after the baseline questionnaire. Recall period is the previous 2 months at 2 months, the previous 4 months at 6 months, and the previous 6 months at 12 months.
Secondary outcome [13] 468038 0
Number of emergency department presentations for musculoskeletal pain, and inpatient admissions arising from those presentations.
Timepoint [13] 468038 0
2, 6 and 12 months after the baseline questionnaire. Recall period is the previous 2 months at 2 months, the previous 4 months at 6 months, and the previous 6 months at 12 months.
Secondary outcome [14] 468039 0
Number of hospital inpatient admissions for musculoskeletal pain other than via the emergency department.
Timepoint [14] 468039 0
2, 6 and 12 months after the baseline questionnaire. Recall period is the previous 2 months at 2 months, the previous 4 months at 6 months, and the previous 6 months at 12 months.
Secondary outcome [15] 468040 0
Number of investigations and procedural treatments received for musculoskeletal pain, by type.
Timepoint [15] 468040 0
2, 6 and 12 months after the baseline questionnaire. Recall period is the previous 2 months at 2 months, the previous 4 months at 6 months, and the previous 6 months at 12 months.
Secondary outcome [16] 468041 0
Medication use for musculoskeletal pain, by medication class.
Timepoint [16] 468041 0
2, 6 and 12 months after the baseline questionnaire. Recall period is the previous 2 months at 2 months, the previous 4 months at 6 months, and the previous 6 months at 12 months.
Secondary outcome [17] 468042 0
Participant out-of-pocket costs for musculoskeletal pain related healthcare.
Timepoint [17] 468042 0
2, 6 and 12 months after the baseline questionnaire. Recall period is the previous 2 months at 2 months, the previous 4 months at 6 months, and the previous 6 months at 12 months.
Secondary outcome [18] 468043 0
Travel time and transportation to and from musculoskeletal pain related healthcare appointments.
Timepoint [18] 468043 0
Baseline questionnaire, and 2, 6 and 12 months after the baseline questionnaire.
Secondary outcome [19] 468064 0
Number of general practice consultations for musculoskeletal pain, at the practice level.
Timepoint [19] 468064 0
Cumulative across the trial period at each cluster (estimated approximately 12 months), commencing at cluster activation.
Secondary outcome [20] 468065 0
Number of general practice initiated referrals to allied health services for musculoskeletal pain, at the practice level.
Timepoint [20] 468065 0
Cumulative across the trial period at each cluster (estimated approximately 12 months), commencing at cluster activation.
Secondary outcome [21] 468066 0
Number of general practice initiated specialist referrals for musculoskeletal pain, at the practice level.
Timepoint [21] 468066 0
Cumulative across the trial period at each cluster (estimated approximately 12 months), commencing at cluster activation.
Secondary outcome [22] 468067 0
Number of general practice initiated diagnostic imaging and investigation referrals for musculoskeletal pain, at the practice level.
Timepoint [22] 468067 0
Cumulative across the trial period at each cluster (estimated approximately 12 months), commencing at cluster activation.
Secondary outcome [23] 468069 0
Number of general practice medication prescriptions for musculoskeletal pain, by class, at the practice level.
Timepoint [23] 468069 0
Cumulative across the trial period at each cluster (estimated approximately 12 months), commencing at cluster activation.
Secondary outcome [24] 468070 0
Number of musculoskeletal interventions and procedures initiated within general practice, at the practice level.
Timepoint [24] 468070 0
Cumulative across the trial period at each cluster (estimated approximately 12 months), commencing at cluster activation.
Secondary outcome [25] 468071 0
Number of funded direct access physiotherapy consultations delivered. Descriptive outcome, intervention clusters only.
Timepoint [25] 468071 0
Cumulative across the trial period at each intervention cluster (estimated approximately 12 months), commencing at cluster activation.
Secondary outcome [26] 468073 0
Number of onward referrals to other health professionals made by physiotherapists delivering the funded direct access service. Descriptive outcome, intervention clusters only.
Timepoint [26] 468073 0
Cumulative across the trial period at each intervention cluster (estimated approximately 12 months), commencing at cluster activation..
Secondary outcome [27] 468085 0
Number of imaging and investigation referrals made by physiotherapists delivering the funded direct access service. Descriptive outcome, intervention clusters only.
Timepoint [27] 468085 0
Cumulative across the trial period at each intervention cluster (estimated approximately 12 months), commencing at cluster activation..

Eligibility
Key inclusion criteria
Participants who meet all the following criteria are eligible to take part in the research evaluation (i.e., asked to complete study questionnaires)
• Adults aged 18 years or over presenting with a musculoskeletal pain or condition who have consulted a participating general practice or participating physiotherapy service.
• Provide informed consent to participate in research data collection
• Can independently complete online eligibility, consent form and study questionnaires in English (or with assistance from a blinded research assistant)
• Have access to a device and internet connection sufficient to receive study invitations and complete electronic study questionnaires.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Participants will be excluded from participation in the research evaluation if they:
• Are unable to provide informed consent
• Are unable to complete study questionnaires or communicate in English
• Have previously enrolled in the study
• Are currently receiving care for their musculoskeletal pain under a fully funded scheme (e.g. workers’ compensation, motor vehicle insurance, National Disability Insurance Scheme)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
General practices (and their affiliated physiotherapy clinic/service) will serve as the unit of randomisation (cluster). Central randomisation will be conducted by the trial statistician, who is independent of site recruitment and practice contact. The allocation sequence will be securely held by the trial statistician. Allocation will remain concealed from the trial coordinator until participating practices have been enrolled, eligibility confirmed, and baseline site characteristics recorded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Practices will be randomised on a rolling basis as they are enrolled and ready for activation. Randomisation will be conducted using a computer-generated allocation sequence, with 1:1 allocation ratio.

Randomisation will be stratified by rurality using the Modified Monash Model (MMM), with clinics classified as MMM 1–2 or MMM 3–5. Within each stratum, allocation will be restricted to maintain balance between trial arms
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using the primary outcome of physical health, measured with the SF-36 Physical Component Summary (PCS) subscale, a total sample size of 1,872 participants across 16 general practice clusters is estimated for this cluster randomised non-inferiority trial. The calculation is based on a non-inferiority margin of 2 points, a standard deviation of 10, 90% power, and a one-sided significance level of 2.5%, incorporating four repeated measurements (baseline, 2, 6, and 12 months). The sample size was inflated to account for clustering and an anticipated 20% loss to follow-up over 12-months, assuming an intracluster correlation coefficient of 0.0075, a coefficient of variation in cluster size of 0.65, and an average cluster size of 117 participants.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2027
Actual
Date of last participant enrolment
Anticipated
1/07/2029
Actual
Date of last data collection
Anticipated
1/07/2030
Actual
Sample size
Target
1872
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC

Funding & Sponsors
Funding source category [1] 321962 0
Government body
Name [1] 321962 0
National Health and Medical Research Council (NHMRC)
Country [1] 321962 0
Australia
Funding source category [2] 322058 0
Commercial sector/Industry
Name [2] 322058 0
Australian Physiotherapy Association
Country [2] 322058 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 324843 0
None
Name [1] 324843 0
Address [1] 324843 0
Country [1] 324843 0
Other collaborator category [1] 283962 0
Other Collaborative groups
Name [1] 283962 0
Musculoskeletal Health Australia
Address [1] 283962 0
Country [1] 283962 0
Australia
Other collaborator category [2] 283972 0
Other Collaborative groups
Name [2] 283972 0
Brisbane North Primary Health Network (BNPHN).
Address [2] 283972 0
Country [2] 283972 0
Australia
Other collaborator category [3] 284072 0
Other Collaborative groups
Name [3] 284072 0
PARTNER Network- Practice Based Research Network
Address [3] 284072 0
Country [3] 284072 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320510 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 320510 0
Ethics committee country [1] 320510 0
Australia
Date submitted for ethics approval [1] 320510 0
10/06/2026
Approval date [1] 320510 0
28/08/2026
Ethics approval number [1] 320510 0
2026/HE000614

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 150670 0
Prof Paulo Ferreira
Address 150670 0
Building D18, Western Avenue, The University of Sydney, NSW 2006, Australia
Country 150670 0
Australia
Phone 150670 0
+61 430 588 696
Fax 150670 0
Email 150670 0
[email protected]
Contact person for public queries
Name 150671 0
Paulo Ferreira
Address 150671 0
Building D18, Western Avenue, The University of Sydney, NSW 2006, Australia
Country 150671 0
Australia
Phone 150671 0
+61 430 588 696
Fax 150671 0
Email 150671 0
[email protected]
Contact person for scientific queries
Name 150672 0
James (Jim) Zouch
Address 150672 0
Building D18, Western Avenue, The University of Sydney, NSW 2006, Australia
Country 150672 0
Australia
Phone 150672 0
+61 455 484 221
Fax 150672 0
Email 150672 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
The timing of data sharing will be determined following completion of the primary and planned secondary analyses.

To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Requests for access to de-identified participant-level data will be considered on a case-by-case basis following publication of the primary study findings. Access will be subject to participant consent, ethical and governance approvals, institutional requirements, any applicable multi-institutional agreements, and execution of an appropriate data sharing agreement. Data will be shared in a de-identified form only, and additional safeguards may be applied to minimise the risk of re-identification



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.