Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001095459
Ethics application status
Approved
Date submitted
17/09/2025
Date registered
8/10/2025
Date last updated
8/10/2025
Date data sharing statement initially provided
8/10/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a multi-disciplinary virtual pain care program for persistent low back pain: A non-randomised study
Scientific title
Evaluation of a multi-disciplinary virtual pain care program for persistent low back pain: A non-randomised study in privately insured participants aged 18-65
Secondary ID [1] 315173 0
None
Universal Trial Number (UTN)
U1111-1327-2294
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
persistent low back pain 338618 0
Condition category
Condition code
Musculoskeletal 334914 334914 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name:
Multidisciplinary biopsychosocial pain education and management program (MoreGoodDays)

Description of the intervention:
The intervention is an 8-week, multidisciplinary biopsychosocial program focused on pain education, psychological therapies, and self-management, delivered digitally and supported by individual health professional consultations. Clinicians are required to be qualified and registered physiotherapists and psychologists and are not required to have specific formal training. However, all clinicians are employees of MoreGoodDays, and as such have experience in persistent pain management in a Telehealth environment, and are familiar with the MoreGoodDays content and approach.

Materials
Participants access the program via the MoreGoodDays website or mobile app (publicly accessible via www.moregooddays.com). Content includes short educational videos, audio resources (e.g., expert and lived experience interviews), written articles, guided movement practices, and interactive tasks (e.g., goal setting, reflection exercises). Automated reminders are provided to support adherence.

Procedures and activities
• Online program: 8 sequential modules, each containing ~5–15 minute components, designed to be completed flexibly by participants within approximately 1 hour per week. Content covers pain science, movement retraining, emotional coping, and strategies for long-term resilience. Modules combine active elements (e.g., guided movement, mindfulness, goal setting, educational tasks) with passive elements (e.g., videos, readings).
• Professional support: Participants receive a total of 8 individual telehealth sessions with clinicians:
o Physiotherapist: 3 core clinical sessions plus 2 additional sessions — one introductory session at program commencement (to welcome participants, clarify goals/barriers, and start the program) and one concluding session at program completion (to plan ongoing progress and long-term self-care).
o Psychologist: 3 core clinical sessions.
Each session typically lasts 30–50 minutes and is designed to reinforce program content, personalise strategies, and address participant questions.

Mode of delivery
• Online modules: self-directed, delivered via internet (MoreGoodDays website/app), completed individually.
• Health professional sessions: delivered individually via secure video-conferencing.

Schedule, duration, and intensity
• Online modules: 8 × ~1-hour modules, delivered weekly over 8 consecutive weeks (with flexibility within each week).
• Professional sessions: 8 × 30–50 minute individual telehealth sessions (5 physiotherapist, 3 psychologist), scheduled across the 8-week program.

Location
All intervention activities occur remotely, in participants’ homes or preferred private locations, via digital access.

Personalisation / adaptation
Health professional sessions are tailored to individual participant needs, based on their progress through the online program and specific questions or challenges. The online program content itself is standardised and delivered uniformly to all participants.

Adherence and fidelity
• Adherence is monitored automatically through the MoreGoodDays platform, which records module completion.
• Fidelity of professional consultations is supported by structured session guides to encourage alignment with program content.
Intervention code [1] 331791 0
Behaviour
Intervention code [2] 331792 0
Rehabilitation
Comparator / control treatment
We will used a reference group from the ePPOC (electronic Persistent Pain Outcomes Collaboration) database. This database has data for people with persistent pain undertaking intervention at pain clinics in Australia and New Zealand. Each participant in the intervention group will be matched with a reference from the database base. The reference group will be matched based on: 1. Having completing a multidisciplinary group program in Australia, 2. Age, 3. Gender, 4. Pain severity. 5. Pain Location (Low back pain) 6. Pain Chronicity 7. Compensible status and 8. Work Status
Control group
Active

Outcomes
Primary outcome [1] 342536 0
Pain Severity
Timepoint [1] 342536 0
Timepoints: Baseline; Immediately following treatment period; 3-months following end of treatment. *The 3-month timepoint is the primary timepoint of interest
Primary outcome [2] 342537 0
Pain Interference
Timepoint [2] 342537 0
Timepoints: Baseline; Immediately following treatment period; 3-months following end of treatment. *The 3-month timepoint is the primary timepoint of interest
Primary outcome [3] 342538 0
Pain beliefs
Timepoint [3] 342538 0
Timepoints: Baseline; Immediately following treatment period; 3-months following end of treatment. *The 3-month timepoint is the primary timepoint of interest
Secondary outcome [1] 451224 0
Pain Self-efficacy
Timepoint [1] 451224 0
Timepoints: Baseline; Immediately following treatment period; 3-months following end of treatment.
Secondary outcome [2] 451226 0
Psychological wellbeing
Timepoint [2] 451226 0
Timepoints: Baseline; Immediately following treatment period; 3-months following end of treatment.
Secondary outcome [3] 451229 0
Patient perceived change
Timepoint [3] 451229 0
Timepoints: Immediately following treatment period; 3-months following end of treatment.
Secondary outcome [4] 451230 0
Patient satisfaction
Timepoint [4] 451230 0
Immediately following intervention period.
Secondary outcome [5] 451231 0
Medication usage
Timepoint [5] 451231 0
Timepoints: Baseline; Immediately following treatment period; 3-months following end of treatment.
Secondary outcome [6] 451232 0
Work-related impairment
Timepoint [6] 451232 0
Timepoints: Baseline; Immediately following treatment period; 3-months following end of treatment.
Secondary outcome [7] 451235 0
Willingness to undergo back surgery
Timepoint [7] 451235 0
Timepoints: Baseline; Immediately following treatment period; 3-months following end of treatment.
Secondary outcome [8] 451240 0
Intervention adherence and engagement will be assessed as a composite outcome, by synthesising data related to: in-app module completion rates and overall program completion..
Timepoint [8] 451240 0
Immediately following intervention period.
Secondary outcome [9] 451241 0
Participant Satisfaction
Timepoint [9] 451241 0
Immediately following intervention period.

Eligibility
Key inclusion criteria
Participants will be adults aged 18–65 years with low back pain as their primary pain site, of at least three months’ duration, and with an average pain intensity of at least 4/10. Eligible participants must have sufficient proficiency in English to understand and respond to questionnaires and engage with the intervention, and must also have reliable access to the internet.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include the presence of neurological comorbidities (e.g., stroke, spinal cord injury), psychiatric or cognitive comorbidities that would prevent successful participation, or uncontrolled mental health conditions that preclude engagement. Participants will also be excluded if they have rheumatic disease (e.g., rheumatoid arthritis), have undergone lumbar surgical intervention in the past 12 months, have scheduled surgery during the intervention or follow-up period, or have a known or suspected diagnosis of serious lumbar pathology (e.g., fracture, radiculopathy, tumour). Pregnancy or being less than six months postpartum will also be grounds for exclusion.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A matched reference group from the ePOCC (electronic Persistent Pain Outcomes Collaboration) will act as a non-randomised control
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive analysis will be performed on both the intervention group and the ePOCC reference group. Analysis will involve all data collected in the study. Continuous variables will be presented with their mean, SD with categorical variables presented with the median and IQR.

For the primary outcome a repeated measures analysis of variation (RM-ANOVA) will be performed assessing both within and between group differences. Greenhouse-Geisser corrections will be applied for violations of the assumption. Planned post-hoc comparisons will be used to further explore statistical differences within and between groups. The 3 time points of interest will be baseline, post intervention and the first follow up (3 months). The criterion for statistical significance will be set at p<0.05. The magnitude of the treatment effects will be represented as: 1. Mean difference scores between and within groups, along with associated 95% CIs, 2. Partial eta squared effect size, and 3. The number of participants reaching MCID (Minimally Clinically Important Difference) thresholds for key outcomes. Secondary outcomes will undergo the same analysis procedures as for the primary.

Where there is no reference group data for an outcome (e.g., patient satisfaction scores) only within group effects will be assessed using a within group RM-ANOVA. Where the outcome variable does not have a baseline (e.g., Patient Global Impression of Change score) between group comparisons will be performed as appropriate for the number of time points (e.g., T-test or non-parametric equivalent for a single timepoint comparison, or a 2(group 1 vs group 2) x 2(immediate followup vs 3-month followup) RM-ANOVA for a multi-timepoint comparison.

Data will also be collected at 1 year. This data will be analysed and published separately to determine if results were maintained following the intervention period.

As part of a parallel study, we will use a mediation analysis to assess the mediating effect of variables such as improved pain beliefs, and intervention adherence, on other key study outcomes.

As part of further planned exploratory study, we will examine potential predictors of outcome within the intervention group, using key sociodemographic, cognitive, clinical, and psychological baseline variables from our data set.

Sample size justification: To detect a small to medium effect in the primary analysis (2 (Group: intervention group vs. reference group) × 3 (Time: baseline, immediate follow-up, 3-month follow-up) repeated measures ANOVA) with an alpha of 0.05 and 80% power, we require between 28 participants (medium effect, np² = 0.06) and 162 participants (small effect, np² = 0.01). To balance feasibility with sufficient power to detect effects at the lower end of this range, and to account for anticipated attrition rates of approximately 20%, we will target recruitment of 150 participants.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/10/2025
Actual
Date of last participant enrolment
Anticipated
31/08/2026
Actual
Date of last data collection
Anticipated
27/09/2027
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319756 0
Commercial sector/Industry
Name [1] 319756 0
Private Health Insurer
Country [1] 319756 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 322252 0
Commercial sector/Industry
Name [1] 322252 0
MoreGoodDays
Address [1] 322252 0
Country [1] 322252 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318299 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 318299 0
Ethics committee country [1] 318299 0
Australia
Date submitted for ethics approval [1] 318299 0
09/04/2025
Approval date [1] 318299 0
17/04/2025
Ethics approval number [1] 318299 0
206776

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

Contacts
Principal investigator
Name 143746 0
Dr Mark Catley
Address 143746 0
University of South Australia, 251/261 North Tce, Adelaide
Country 143746 0
Australia
Phone 143746 0
+61 08 8302 2071
Fax 143746 0
Email 143746 0
[email protected]
Contact person for public queries
Name 143747 0
Daniel Harvie
Address 143747 0
University of South Australia, 251/261 North Tce, Adelaide
Country 143747 0
Australia
Phone 143747 0
+61 08 88 302 1265
Fax 143747 0
Email 143747 0
[email protected]
Contact person for scientific queries
Name 143748 0
Daniel Harvie
Address 143748 0
University of South Australia, 251/261 North Tce, Adelaide
Country 143748 0
Australia
Phone 143748 0
+61 08 88 302 1265
Fax 143748 0
Email 143748 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.