Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001184561p
Ethics application status
Not yet submitted
Date submitted
31/07/2024
Date registered
27/09/2024
Date last updated
27/09/2024
Date data sharing statement initially provided
27/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Behavioural Therapy-informed Virtual Reality (VR-CBT) for low back pain
Scientific title
Cognitive behavioural therapy-informed virtual reality: a randomised controlled trial evaluating the feasibility and efficacy for pain and disability outcomes in people with persistent low back pain.
Secondary ID [1] 312658 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 334627 0
Condition category
Condition code
Musculoskeletal 331209 331209 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo an initial VR-CBT intervention (total 90 minutes). This will include i) a standardized pain education session (45 min); ii) Virtual reality gameplay (20min) with guided post-gameplay reflection (15 minutes); and iii) setup for home-based use of VR gameplay and mindfulness (10 minutes).
i) Pain education: The standardised session will be delivered by an experienced physiotherapist and will cover topics including pain science education and graded activity strategies. Pain physiology will include a basic overview of how the nervous system works and its role in persistent pain, outlining contrasts between acute pain and chronic pain, and addressing potentially unhelpful health beliefs. People with persistent pain have decreased activity levels as a result of either avoidance of symptoms, or engaging in activity in a way that severely worsens pain severity, leading to extended periods of rest. To address this, participants will establish their current baseline (e.g. walking 20 minutes), and pacing strategies will be explained to increase physical activity using quota contingences to minimise flare up of symptoms (e.g. start at 15 minutes, 3 times a week, and increase duration by 5% weekly). Participants will have the opportunity to ask specific questions relating to the session content. A handout summarizing the presentation content will be provided
ii) Virtual Reality Gameplay with guided post-gameplay reflection: Participants will be familiarized with the Oculus Quest 2 virtual reality system (Oculus VR, California USA) before undergoing 20 minutes VR gameplay - 3x5 minute sessions with small breaks. This session will be supervised by the physiotherapist researcher. The emphasis of the VR session will be graduated exposure to forward bending during self-paced, age-appropriate game scenarios (i.e.: throwing basketball through hoop, air hockey, 10-pin bowling). Video footage will be collected during VR gameplay using LIV Augmented reality capture and recorded using OBS Studio software. Following gameplay, participants will be guided through a 15-minute reflective learning interview delivered by the physiotherapist researcher to consolidate links between pain education content and the virtual reality experience using a semi-structured interview process. Video footage will also be replayed to the participant in which positive movement strategies will be highlighted.
iii) Home-based use of VR gameplay and mindfulness: Participants will be instructed to complete 3-4 sessions of VR each week consisting of 20 minutes of gameplay followed by 10 minutes of mindfulness. The specific number of sessions will be based on participant availability. A suite of VR games will be available, and selection and progression of games will be participant-specific, developed with the participant by the Research Officer (a physiotherapist); and guided by their presenting condition (i.e., elicited aggravating movements, apprehension with movement, baseline pain severity) and initial response to VR-CBT. A progression plan will be developed by the research officer with gradual increases in movement requirements (range and speed of movement) during gameplay over the 4-week intervention period. Mindfulness sessions will be completed on Guided Meditation VR. Participants will be seated and guided through mindfulness strategies such as deep breathing, body scanning, and relaxation strategies. Participants will have opportunity to contact the researcher if required to adjust the intervention or flag any issues. Participants will additionally be provided with weekly reflective learning insights electronically or by post (depending on participant preference) designed to consolidate pain education learning. These will be standardised based on the education content and will take approximately 5 minutes to read.
Intervention code [1] 329178 0
Treatment: Devices
Comparator / control treatment
Wait list Control. Participants in the control arm will be encouraged to engage with education, advice or exercises (received at the discretion of the treating clinician at initial clinical assessment), followed by a 4-week wait prior to commencing any agreed multidisciplinary care within the Royal Brisbane and Women's Hospital or Surgical, Treatment and Rehabilitation Services. Participants will be able to access any external services or treatment during the 4-week wait period.
Control group
Active

Outcomes
Primary outcome [1] 338977 0
Pain
Timepoint [1] 338977 0
Baseline, 4 weeks (upon completion of intervention), 12 weeks, 24 weeks post-baseline.
Primary outcome [2] 338978 0
Kinesiophobia
Timepoint [2] 338978 0
Baseline, 4 weeks (upon completion of intervention), 12 weeks, 24 weeks post-baseline.
Primary outcome [3] 338979 0
Disability
Timepoint [3] 338979 0
Baseline, 4 weeks (upon completion of intervention), 12 weeks, 24 weeks post-baseline.
Secondary outcome [1] 438178 0
Activity
Timepoint [1] 438178 0
Baseline, 4 weeks (upon completion of intervention), 12 weeks, 24 weeks post-baseline
Secondary outcome [2] 438179 0
Quality of Life
Timepoint [2] 438179 0
Baseline, 4 weeks (upon completion of intervention), 12 weeks, 24 weeks post-baseline
Secondary outcome [3] 438180 0
Global Rating of Change
Timepoint [3] 438180 0
4 weeks (upon completion of intervention), 12 weeks, 24 weeks post baseline
Secondary outcome [4] 438181 0
Patient-specific Function
Timepoint [4] 438181 0
Baseline, 4 weeks (upon completion of intervention), 12 weeks, 24 weeks post-baseline
Secondary outcome [5] 438182 0
Healthcare utilisation
Timepoint [5] 438182 0
4 weeks (upon completion of intervention) and every subsequent 4 weeks until 24 weeks post-baseline
Secondary outcome [6] 438183 0
Intervention acceptability
Timepoint [6] 438183 0
4 weeks (upon completion of intervention)
Secondary outcome [7] 438751 0
Overactivity
Timepoint [7] 438751 0
Baseline, 4 weeks (upon completion of intervention), 12 weeks, 24 weeks post-baseline
Secondary outcome [8] 439829 0
Productivity
Timepoint [8] 439829 0
Baseline, 4 weeks (upon completion of intervention), 12 weeks, 24 weeks post-baseline

Eligibility
Key inclusion criteria
1. Low back pain great than or equal to 3 months
2. Aged 18-65 years
3. At least moderate pain-related fear of movement (greater than or equal to 35 on Tampa Scale of Kinesiophobia)
4. At least moderate LBP-related disability (Greater than or equal to 22% on Oswestry Disability Scale)
5. Minimum average pain of 4 on 11-point numeric rating scale
6. Access to a mobile phone for SMS
7. Unobstructed space 2.5m x 2.5m for completing VR gameplay in their home
8. Able to mobilise without an aid
9. Referred from service (i.e. Musculoskeletal Physiotherapy Screening Clinic; Tess Cramond Pain and Research Centre) for conservative management by member of multidisciplinary team.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Specific diagnosis impacting capacity for forward bending (e.g. unstable spondylolisthesis)
2. Current pregnancy
3. Severe vertigo
4. Severe susceptibility to motion sickness
5. Back pain of a non-musculoskeletal cause
6. Severe neurological deficit or symptoms (e.g., cauda equina syndrome, myelopathy, or evidence of nerve root compromise)
7. Medical conditions contra-indicating physical exercise
8. Insufficient understanding of English and inability to follow directions and instructions.
9. Current use of VR for gaming or mindfulness
10. Specific pain education delivered by a health professional in previous 6 months
11. Previous back surgery

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)
Allocation will not be concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participants will be block randomized to ensure balance in the small sample size in this project. The block randomization procedure will be to allocate participants to blocks with a block size of 4 with 6 different allocations combinations with 2 control and 2 treatments (Kang, Ragan and Park, 2008; Bruce et al., 2022). To ensure genuine randomization, the allocator will hide the block size from the executer. (Kim and Shin, 2014). Separate allocation blocks will be used at each site (RBWH and STARS) to ensure equal representation of participants from each site in both arms.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
waitlist-control design. Participants allocated to waitlist will undergo a standardised 4-week wait to commence treatment, as per approximate current wait times for both services. Participants allocated to the intervention will undertake the 4-week intervention prior to commencing treatment. The participants will be block randomized to ensure balance in the small sample size in this project. The block randomization procedure will be to allocate participants to blocks with a block size of 4 with 6 different allocations combinations with 2 control and 2 treatments.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Process outcomes (eligibility and recruitment, retention and adherence rate, adverse events) will be analysed using descriptive statistics. All baseline data will be checked for normality using Shapiro-Wilk test (P > 0.05). If not otherwise stated, mean and 95% confidence interval values will be reported if the data are normally distributed; otherwise, data will be presented as median and interquartile range (IQR). Means and standard deviations of clinical outcomes (within- and between-groups) will determine sensitivity to change of outcomes and inform both the selection of the primary outcome measure (i.e. pain intensity, Tampa Scale of Kinesiophobia), the optimal timepoint (4 weeks, 12 weeks or 24 weeks) and the calculated sample size required for an adequately powered trial. A descriptive analysis of the EQ-5D measure will test if a difference in quality of life (measured by EQ5D) between study arms may be detected, which could be used in a cost-utility analysis in a fully powered future RCT. The indicative number of health practitioner contacts for treatment of LBP will be evaluated between both arms to inform the collection of cost information in a future trial

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/10/2024
Actual
Date of last participant enrolment
Anticipated
25/08/2025
Actual
Date of last data collection
Anticipated
23/02/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317091 0
Charities/Societies/Foundations
Name [1] 317091 0
RBWH Foundation
Country [1] 317091 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Country
Australia
Secondary sponsor category [1] 319347 0
Charities/Societies/Foundations
Name [1] 319347 0
RBWH Foundation
Address [1] 319347 0
Country [1] 319347 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315840 0
Metro North Health Human Research Ethics Committee B
Ethics committee address [1] 315840 0
Ethics committee country [1] 315840 0
Australia
Date submitted for ethics approval [1] 315840 0
02/10/2024
Approval date [1] 315840 0
Ethics approval number [1] 315840 0

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

Contacts
Principal investigator
Name 135966 0
Dr Peter Window
Address 135966 0
Royal Brisbane and Women's Hospital, Butterfield St HERSTON Qld 4006
Country 135966 0
Australia
Phone 135966 0
+61 0736464319
Fax 135966 0
Email 135966 0
peter.window@health.qld.gov.au
Contact person for public queries
Name 135967 0
Peter Window
Address 135967 0
Royal Brisbane and Women's Hospital, Butterfield St HERSTON Qld 4006
Country 135967 0
Australia
Phone 135967 0
+61 0736464319
Fax 135967 0
Email 135967 0
peter.window@health.qld.gov.au
Contact person for scientific queries
Name 135968 0
Peter Window
Address 135968 0
Royal Brisbane and Women's Hospital, Butterfield St HERSTON Qld 4006
Country 135968 0
Australia
Phone 135968 0
+61 0736464319
Fax 135968 0
Email 135968 0
peter.window@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Clinical and cost-related outcome measures
When will data be available (start and end dates)?
Following completion of trial and dissemination of findings. Available for 15 years following completion of data collection.
Available to whom?
Available to interested parties upon reasonable request
Available for what types of analyses?
For various analyses upon reasonable request.
How or where can data be obtained?
Through email correspondence with the trial contact person (peter.window@health.qld.gov.au)


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.