Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000930482p
Ethics application status
Submitted, not yet approved
Date submitted
12/08/2025
Date registered
27/08/2025
Date last updated
27/08/2025
Date data sharing statement initially provided
27/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing Online and Face-to-Face Pain Education for People Waiting for Chronic Pain Care
Scientific title
A Pilot Randomised Controlled Trial Comparing Online Versus Face-to-Face Delivery of the STEPS Pre-Clinic Group Education Program for Patients Awaiting Multidisciplinary Chronic Pain Care
Secondary ID [1] 315103 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 338509 0
Anaesthesiology 338510 0
Pain management 338511 0
Condition category
Condition code
Musculoskeletal 334816 334816 0 0
Other muscular and skeletal disorders
Anaesthesiology 334817 334817 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a pre-clinic pain education program (STEPS) delivered as a single-session group workshop via videoconferencing. The STEPS program is facilitated by experienced clinicians from the Royal Prince Alfred Hospital Pain Management Centre (such as psychologists, physiotherapists, or pain specialists) and runs for approximately two hours. The session provides interactive education covering the science of chronic pain, strategies for self-management including pacing, activity management, and lifestyle approaches, and information about available treatment options and care pathways within the pain clinic. Participants are given opportunities for questions and group discussion. Attendance at the videoconference is recorded, and reminders are sent in advance to encourage participation. The STEPS program is scheduled prior to participants’ first multidisciplinary pain clinic appointment, with the aim of preparing them for clinic assessment and optimising engagement with subsequent care.
Intervention code [1] 331725 0
Behaviour
Intervention code [2] 331726 0
Lifestyle
Comparator / control treatment
Face-to-face delivery of the pre-clinic group pain education program (STEPS) at the Royal Prince Alfred Hospital or Westmead Hospital Pain Clinic. The content, structure, and duration of the session are equivalent to the online version, with the only difference being the mode of delivery.
Control group
Active

Outcomes
Primary outcome [1] 342451 0
Recruitment rate: Proportion of eligible participants who consent to participate.
Timepoint [1] 342451 0
3 months post-intervention commencement.
Primary outcome [2] 342533 0
Retention rate: Proportion of participants who complete follow-up assessments
Timepoint [2] 342533 0
At the end of the study.
Primary outcome [3] 342534 0
Program completion: Proportion of participants who attend the full STEPS session.
Timepoint [3] 342534 0
At the end of the STEPS program
Secondary outcome [1] 450854 0
Hearing barriers
Timepoint [1] 450854 0
Baseline only
Secondary outcome [2] 450855 0
Health literacy
Timepoint [2] 450855 0
Baseline only
Secondary outcome [3] 450856 0
Pain self-efficacy
Timepoint [3] 450856 0
Baseline, 1 week post-STEPS, 3 months post-STEPS
Secondary outcome [4] 450857 0
Pain stages of change
Timepoint [4] 450857 0
Baseline, 1 week post-STEPS, 3 months post-STEPS
Secondary outcome [5] 450858 0
Health-related quality of life
Timepoint [5] 450858 0
Baseline, 1 week post-STEPS, 3 months post-STEPS
Secondary outcome [6] 450859 0
Physical functioning
Timepoint [6] 450859 0
Baseline, 1 week post-STEPS, 3 months post-STEPS
Secondary outcome [7] 450860 0
Client satisfaction
Timepoint [7] 450860 0
1 week post-STEPS, 3 months post-STEPS
Secondary outcome [8] 450861 0
Technology experience (online arm only)
Timepoint [8] 450861 0
Baseline only
Secondary outcome [9] 450862 0
Wait times for multidisciplinary pain clinic entry
Timepoint [9] 450862 0
From referral to clinic entry (baseline to 3 months post-STEPS).
Secondary outcome [10] 450863 0
Participant experiences of the STEPS program, perceived benefits, barriers to participation, and suggestions for program improvement (treated as a composite qualitative outcome).
Timepoint [10] 450863 0
3 months post-STEPS
Secondary outcome [11] 451204 0
Emotional functioning
Timepoint [11] 451204 0
Baseline, 1 week post-STEPS, and 3 months post-STEPS.
Secondary outcome [12] 451205 0
Technology usability (online arm only)
Timepoint [12] 451205 0
Baseline only.
Secondary outcome [13] 451206 0
Speech barriers
Timepoint [13] 451206 0
Baseline
Secondary outcome [14] 451208 0
Attrition post-STEPS (failure to proceed to clinic or program after STEPS participation
Timepoint [14] 451208 0
Within 3 months post-STEPS
Secondary outcome [15] 451209 0
Occasions of service
Timepoint [15] 451209 0
From STEPS completion to 3 months post-STEPS.
Secondary outcome [16] 451210 0
New-to-follow-up ratio
Timepoint [16] 451210 0
Within 3 months post-STEPS.
Secondary outcome [17] 451211 0
Patient disposition
Timepoint [17] 451211 0
At 3 months post-STEPS.
Secondary outcome [18] 451212 0
Staffing time and associated costs will be assessed independently as part of the health service outcomes. In addition to recording staff time (clinical and administrative) required to deliver each format of the STEPS program, associated costs will include: - Salary-related costs for clinicians involved in program delivery (e.g., nursing, physiotherapy, occupational therapy, psychology). - Administrative support costs, such as time for scheduling, booking, and follow-up. - Technology-related costs for the online arm (e.g., videoconferencing licences, IT support). - Facility use costs for the face-to-face arm (e.g., room hire, equipment use where applicable). Data on staffing time will be collected via a password-protected log completed by facilitators and administrative staff after each STEPS session. Associated costs will be calculated using standard SLHD health service cost schedules and/or award rates for staff time.
Timepoint [18] 451212 0
Across the study period (administrative, booking, and program delivery)
Secondary outcome [19] 451213 0
Other group participation
Timepoint [19] 451213 0
Within 3 months post-STEPS.

Eligibility
Key inclusion criteria
Adults aged 18 years or older.

Referred to the Royal Prince Alfred Hospital Pain Management Centre or Westmead Hospital Pain Clinic.

On the waitlist to attend the Self-Training Educative Pain Sessions (STEPS) program.

Able to provide informed consent.

Access to a device with internet connection (for participants randomised to the online delivery arm).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to understand or communicate in English sufficiently to complete study procedures without an interpreter.

Significant cognitive impairment or severe psychiatric illness that, in the opinion of the treating clinician or research team, would interfere with participation.

Medical instability or acute health condition requiring urgent treatment.

Previous completion of the Self-Training Educative Pain Sessions (STEPS) program within the past 12 months.

Lack of access to an appropriate device and internet connection (for participants randomised to the online delivery arm).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer via a secure, password-protected REDCap database, with allocation sequence concealed from investigators and clinicians until the point of assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation sequence will be created using random permuted blocks of varying sizes, stratified by site (Royal Prince Alfred Hospital and Westmead Hospital) to ensure balanced allocation between online and face-to-face STEPS delivery arms.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will summarise feasibility outcomes (recruitment, retention, program completion) with 95% confidence intervals. Secondary continuous outcomes (e.g., PSEQ, EQ-5D-5L, PROMIS-29) will be analysed using linear mixed-effects models including fixed effects for time, group, and time-by-group interaction, with random intercepts for participants. Categorical outcomes will be compared between groups using chi-square or Fisher’s exact tests as appropriate. Analyses will follow the intention-to-treat principle, with sensitivity analyses for per-protocol completion. Qualitative interview data will be analysed thematically to explore participant experiences and contextualise quantitative findings. No formal hypothesis testing is planned; results will inform the design of a fully powered trial.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
30/04/2026
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319679 0
Other
Name [1] 319679 0
ANZCA pilot grant
Country [1] 319679 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital, Pain management centre
Address
Country
Australia
Secondary sponsor category [1] 322183 0
University
Name [1] 322183 0
Univeristy of Sydney
Address [1] 322183 0
Country [1] 322183 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318242 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 318242 0
Ethics committee country [1] 318242 0
Australia
Date submitted for ethics approval [1] 318242 0
18/08/2025
Approval date [1] 318242 0
Ethics approval number [1] 318242 0

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

Contacts
Principal investigator
Name 143542 0
Dr Emma Zhao
Address 143542 0
Royal Prince Alfred Hospital Pain Management Centre Missenden Road Camperdown NSW 2050 Australia
Country 143542 0
Australia
Phone 143542 0
+61 451559678
Fax 143542 0
Email 143542 0
[email protected]
Contact person for public queries
Name 143543 0
Emma Zhao
Address 143543 0
Royal Prince Alfred Hospital Pain Management Centre Missenden Road Camperdown NSW 2050 Australia
Country 143543 0
Australia
Phone 143543 0
+61 451559678
Fax 143543 0
Email 143543 0
[email protected]
Contact person for scientific queries
Name 143544 0
Emma Zhao
Address 143544 0
Royal Prince Alfred Hospital Pain Management Centre Missenden Road Camperdown NSW 2050 Australia
Country 143544 0
Australia
Phone 143544 0
+61 451559678
Fax 143544 0
Email 143544 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 scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Safety 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:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Dr Emma Zhao
Coordinating Principal Investigator
Royal Prince Alfred Hospital Pain Management Centre, Sydney Local Health District
[email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Requests for access to de-identified individual participant data will be assessed on a case-by-case basis. Data sharing will require:

Submission of a written research proposal with a clear and methodologically sound analysis plan.

Approval from a recognised Human Research Ethics Committee (HREC) or equivalent institutional review board.

A signed data sharing and confidentiality agreement outlining data use, storage, and destruction protocols.

Agreement that the data will be used only for the purposes outlined in the approved proposal and will not be shared with third parties without permission.

Priority will be given to proposals that align with the original study aims, promote public health benefit, and have appropriate statistical expertise.





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.