Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000794404
Ethics application status
Approved
Date submitted
16/07/2025
Date registered
25/07/2025
Date last updated
25/07/2025
Date data sharing statement initially provided
25/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain Smart: Integrating pain education and case management for adolescents with pain at schools. Part 2 of a Protocol for a Combined Cluster Randomised Controlled Trial and Individually-Randomised Controlled Trial.
Scientific title
Pain Smart: Integrating pain education and case management for adolescents with pain at schools. Part 2 of a Protocol for a Combined Cluster Randomised Controlled Trial and Individually-Randomised Controlled Trial.
Secondary ID [1] 314917 0
APP2017114
Universal Trial Number (UTN)
Trial acronym
PAIN SMART Main Trial - Part 2
Linked study record
The registration record ACTRN12624000253505 is the feasibility study for this current study

Health condition
Health condition(s) or problem(s) studied:
Pain 338238 0
Condition category
Condition code
Public Health 334518 334518 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pain SmartER vc No Pain SmartER
Pain SmartER (Extended Resources) case management is an opportunity for adolescents to access additional biopsychosocial advice, support and guidance for their pain. It is an individually tailored extension of the content to be provided in the Pain Smart education module. Pain SmartER case management aims to reduce pain interference among participants by building self-efficacy to manage pain and navigating continuation and return to usual activities. Recruitment for trial 2 will commence after the 3-month follow up in trial 1. Participants will be connected to a Pain Navigator (member of the study team), a registered health professional from our research team with experience managing adolescents with pain. The Pain Navigator and participant will meet via Zoom or phone call for 30 minutes up to four times within a one month period. Session attendance will be used to monitor adherence to the intervention. If the participant declines a Zoom or phone call session, the Pain Navigator will offer to deliver Pain SmartER via SMS or email. Initially, the Pain Navigator will ask the participant questions about their pain, their relevant social and medical history, and how the pain is interfering with their life. The Pain Navigator will also screen for any mental health or serious pathology requiring urgent medical attention. If there is suspicion of serious or specific pathology or mental health condition requiring further assessment, the Pain Navigator will recommend the participant to see a GP and provide a summary letter to the GP. The Pain Navigator will follow up with the participant to determine the outcome of further assessment and provide advice, support and guidance as indicated.
Pain SmartER case management will be tailored towards issues, barriers and goals identified by the participant and Pain Navigator during the initial conversation. Using principles of goal setting, cognitive behavioural therapy and motivational interviewing, the subsequent conversations may include:
1. Information and resources about pain and pain management (Pain SmartER Toolkit)
2. Strategies to manage pain and return to usual activities
3. Recommendations for further assessment and/or treatment from other health and medical professionals, including referrals to other services when appropriate.
If the participant declines Pain SmartER via Zoom/phone call and SMS/email, the Pain Navigator will offer to send the participant the Pain SmartER Toolkit. The Pain SmartER Toolkit will include written information about pain and strategies to manage pain aligned with the biopsychosocial model. The participant will be advised they can contact the Pain Navigator for further advice, support and guidance as needed.
The Pain Navigator will provide a summary of the conversation to the participant’s parent, general practitioner or other health practitioner as required. They will also work with the school nurse and/or school counsellor when required. The Pain SmartER advice, support and guidance will be based on the WHO guidelines for management of pain with children. These guidelines recommend biopsychosocial assessment and management, care given by healthcare providers skilled and experienced in chronic pain, comprehensive and integrated care, and an interdisciplinary, multimodal approach to pain management.
Intervention code [1] 331524 0
Treatment: Other
Intervention code [2] 331525 0
Behaviour
Comparator / control treatment
Control group will be offered to receive the same intervention after the end of the study (after the 12 month follow up assessment), but no intervention during the study period.
Control group
Active

Outcomes
Primary outcome [1] 342197 0
Pain Interference
Timepoint [1] 342197 0
3 months post-intervention commencement
Secondary outcome [1] 449901 0
Pain interference
Timepoint [1] 449901 0
12 months post-intervention commencement
Secondary outcome [2] 449902 0
Pain characteristics and impact - This will be assessed as a composite outcome
Timepoint [2] 449902 0
3 and 12 months post-intervention commencement
Secondary outcome [3] 449903 0
Pain self-efficacy
Timepoint [3] 449903 0
3 and 12 months post-intervention commencement
Secondary outcome [4] 449907 0
Pain Interference
Timepoint [4] 449907 0
3 months post-intervention commencement

Eligibility
Key inclusion criteria
Participants will be adolescents in grades 7-10 (ages 11-16) attending a mainstream Australian secondary school in Sydney participating in Trial Part 1. Eligible participants will be adolescents attending schools allocated to the intervention arm (pain education) in trial 1. Participants reporting bothersome pain, in this study identified as pain that has been ‘some’, ‘a lot’ or ‘a whole lot’ of a problem in the past month on the Paediatric Pain Screening Tool, item 9 at the 3-month follow up survey or the monthly SMS/email follow up assessment at months 4-11 in trial 1, who assent and have parental consent to participate in the study will be eligible. No participants will be excluded.
Minimum age
11 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools for Specific Purposes (i.e., specialised educational settings for students with moderate to high learning and support needs) will be excluded.

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)
Participants will be randomly allocated (1:1) to the biopsychosocial case management intervention or to the control group. When a participant meets the criteria for case management (reports bothersome pain), the REDCap randomisation module will allocate the participant to the intervention or control based on the randomisation schedule. This will ensure allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician who is not involved in recruitment will generate a randomization schedule on Microsoft Excel, which will be input to the REDCap database.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to summarise the characteristics of the sample. Continuous data will be summarised with means and standard deviation, or medians and IQR as appropriate, categorical data will be summarised with counts and proportions. The mean difference in scores at 12-months (and 3-months as secondary outcome) between groups will be estimated with a linear mixed model that includes a random intercept for each study site to adjust for cluster randomisation. The analysis will be completed using all available data under the intention-to-treat approach, with alpha=0.05. These main analyses will be robust to data that is missing-at-random, and we will consider the effect of data that is missing-not-at-random by a tipping point analysis with controlled imputations and a shift parameter that represents plausible scenarios. Before the database is locked, a detailed statistical analysis plan will be prepared by blinded investigators and registered in an appropriate repository.
A similar linear mixed model to the main analysis will be used for continuous secondary outcomes. A generalised linear mixed model (with logit link and binary distribution) will be used for binary secondary endpoints. Continuous data will be summarised with means and standard deviation, or medians and IQR as appropriate, categorical data will be summarised with counts and proportions.

Cost of delivering the intervention
We will estimate the cost of delivering the intervention. Pain Navigators will complete a timesheet for each encounter with a participant, specifying the health professional delivering the intervention, the type of intervention (e.g., audiovisual consultation, email or SMS correspondence) and the duration of the intervention. The cost will be calculated based on the Australian Government Comcare telehealth rates for medical and allied health treatment (Rates for medical and allied health treatment | Comcare).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2025
Actual
Date of last participant enrolment
Anticipated
2/11/2026
Actual
Date of last data collection
Anticipated
8/11/2027
Actual
Sample size
Target
206
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319481 0
Government body
Name [1] 319481 0
The Commonwealth of Australia Medical Research Future Fund (MRFF) for Research Activities
Country [1] 319481 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 321969 0
Government body
Name [1] 321969 0
NHRMC
Address [1] 321969 0
Country [1] 321969 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318053 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 318053 0
Ethics committee country [1] 318053 0
Australia
Date submitted for ethics approval [1] 318053 0
22/11/2024
Approval date [1] 318053 0
12/02/2025
Ethics approval number [1] 318053 0
2024/HE001772

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

Contacts
Principal investigator
Name 142970 0
Dr Tie Parma Yamato
Address 142970 0
The University of Sydney - 62 Derby St, Kingswood, NSW 2747, Australia
Country 142970 0
Australia
Phone 142970 0
+61 0404138248
Fax 142970 0
Email 142970 0
[email protected]
Contact person for public queries
Name 142971 0
Tie Parma Yamato
Address 142971 0
The University of Sydney - 62 Derby St, Kingswood, NSW 2747, Australia
Country 142971 0
Australia
Phone 142971 0
+61 0404138248
Fax 142971 0
Email 142971 0
[email protected]
Contact person for scientific queries
Name 142972 0
Tie Parma Yamato
Address 142972 0
The University of Sydney - 62 Derby St, Kingswood, NSW 2747, Australia
Country 142972 0
Australia
Phone 142972 0
+61 0404138248
Fax 142972 0
Email 142972 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.