Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000455864
Ethics application status
Approved
Date submitted
11/03/2021
Date registered
19/04/2021
Date last updated
21/04/2023
Date data sharing statement initially provided
19/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of simulating functional tasks during an immersive virtual reality environment on pain and fear of movement in people with chronic non-specific low back pain.
Scientific title
The effect of simulating functional tasks during an immersive virtual reality environment on pain and fear of movement in people with chronic non-specific low back pain.
Secondary ID [1] 303597 0
Nil known
Universal Trial Number (UTN)
U1111-1265-7346
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain 320968 0
Condition category
Condition code
Musculoskeletal 318775 318775 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The effect of simulating functional tasks during an immersive virtual reality environment on pain and fear of movement in people with chronic non-specific low back pain.

Virtual reality (VR) with cognitive behavioural therapy and pain education on reported pain and fear avoidance beliefs, trunk movement, physical activity levels among individuals with chronic low back pain.

The participants will be taken through a 30 minute standardised pain education session. The session has been designed specifically for this study, and a hand out will be provided which is not publicly available. There is no prescription of exercise or activity from this session.

The second session, the participants will have three rounds of VR gameplay of five minutes duration using the Oculus Quest 2 head mounted display. The emphasis of the VR-CBT 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). During VR-CBT intervention, video footage and 3D motion capture will be simultaneously collected. Following gameplay, the cognitive behavioural therapy will be incorporated by video footage replayed to the participant in which positive movement strategies will be highlighted, while 3D motion capture will be used to express trunk movement as a proportion of their maximum obtained during standardized movement tasks.

The first session will be 1.5 hours, the second session will be 1.5 hours, the third will be 45 minutes. These three sessions will be over a 2 week period. Attendance will be monitored for these three sessions via a checklist.

The intervention provider is a physiotherapist with experience in pain education and chronic low back pain with 5 years experience. This intervention will be the same for all participants.

The intervention will be delivered face to face and will be performed individually.

The intervention will occur at the Surgical, Treatment and Rehabilitation Services building in Herston, QLD. There is a dedicated research room in this facility.
Intervention code [1] 319883 0
Treatment: Devices
Intervention code [2] 320221 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326721 0
Fear of movement as assessed by the Tampa Scale of Kinesiophobia
Timepoint [1] 326721 0
Week 0 - pain education session
Week 1 - VR-CBT
Week 2 - repeat assessments (primary time point) post-intervention completion.
Primary outcome [2] 326722 0
Pain - average pain level (over the proceeding 7 days) will be recorded on a numeric rating scale of 0 - 10 anchored by ‘no pain’ (0) and ‘pain as bad as it could be’ (10).
Timepoint [2] 326722 0
Week 0 - pain education session
Week 1 - VR-CBT
Week 2 - repeat assessments (primary time point) post-intervention completion.
Secondary outcome [1] 392468 0
Kinematics: Three-dimensional movement of the lumbo-pelvic-hip complex will be quantified using a 5-camera OptiTrack motion analysis system (NaturalPoint Inc, Oregon USA)
Timepoint [1] 392468 0
Week 0 - pain education session
Week 1 - VR-CBT
Week 2 - repeat assessments post-intervention completion.
Secondary outcome [2] 392469 0
Daily Physical Activity: Research grade physical activity monitors (ActivPALTM, Glasgow UK) will be attached to the participant’s thigh to measure time spent in moderate-vigorous physical activity over a 7-day period.
Timepoint [2] 392469 0
Week 0 - pain education session
Week 1 - VR-CBT
Week 2 - repeat assessments post-intervention completion.

Eligibility
Key inclusion criteria
Participants with CLBP (=3 months duration) will be included if they demonstrate fear-avoidance beliefs ( greater than or equal to 35 on Tampa Scale of Kinesiophobia), at least moderate CLBP related disability (greater than or equal t0 22% on Oswestry Disability Index), and minimum average pain of 3 on an 11-point numerical rating scale.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include specific diagnoses impacting capacity for forward bending (e.g. spondylolisthesis, disc herniation), pregnancy, back pain of a non-musculoskeletal cause, severe neurological deficit or symptoms (e.g. cauda equina syndrome, myelopathy or evidence of nerve root compromise), medical disorders contra-indicating physical exercise, or specific back muscle training within the last 6 months.

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size has been calculated to detect significant reduction in fear of movement (between baseline and VR-CBT time points) with power of 0.80, a 0.05, and effect size d=0.8. A moderate effect size was considered reasonable given more prolonged interventions demonstrating effect sizes greater than 1.0 for fear of movement in the CLBP population.

A Repeated Measures one-way ANOVA with Timepoint (Baseline, Post-intervention A (PNE), post-intervention B (VR-CBT) as an independent variable and fear-avoidant beliefs, pain (Objective 1), kinematics (Objective 2) and activity levels (Objective 3) as dependent variables will be performed to compare outcomes across the three timepoints, with significance level set at p=0.05. Post-hoc testing with Bonferroni corrections will be used to determine significant differences between individual timepoints. All analysis will be undertaken using SPSS v25.00 software.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/05/2021
Actual
14/07/2021
Date of last participant enrolment
Anticipated
31/07/2023
Actual
Date of last data collection
Anticipated
14/08/2023
Actual
Sample size
Target
37
Accrual to date
34
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18850 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 33349 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 308019 0
Charities/Societies/Foundations
Name [1] 308019 0
RBWH Foundation
Country [1] 308019 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital Physiotherapy Department
Address
Level 2, Ned Hanlon Building
Butterfield St
Herston, QLD, 4006
Country
Australia
Secondary sponsor category [1] 308741 0
None
Name [1] 308741 0
Address [1] 308741 0
Country [1] 308741 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308009 0
Metro North Hospital and Health Service HREC
Ethics committee address [1] 308009 0
Block 7, Metro North Office of Research
Royal Brisbane and Women’s Hospital Campus
Butterfield St, HERSTON QLD 4029
Ethics committee country [1] 308009 0
Australia
Date submitted for ethics approval [1] 308009 0
09/04/2021
Approval date [1] 308009 0
20/04/2021
Ethics approval number [1] 308009 0

Summary
Brief summary
Chronic Low Back Pain (CLBP) is a major health issue worldwide. Pain-related fear and activity avoidance are the most recognised barriers to recovery. Virtual Reality-based Cognitive Behavioural Therapy (VR-CBT) is an emerging exercise and education approach designed to better target fear and activity avoidance through graded exposure to movement by simulating an engaging environment, and reinforcing positive pain beliefs through education and augmented video feedback on performance. This project aims to evaluate the outcomes of VR-CBT on 1: fear-avoidance beliefs, reported pain; and 2: trunk movement; and 3: physical activity, in individuals with CLBP. The participants will be a single cohort of 49 individuals (18-65 years) with CLBP and at least moderate fear avoidance beliefs, quality of life and pain severity. These participants will be recruited through the RBWH Physiotherapy Department. This will be a repeated measures single-arm study. The expected outcomes are: the addition of VR-CBT to standardized PNE alone will reduce reported pain and fear-avoidance beliefs, increase trunk movement and walking speed, and increase physical activity levels during daily life among individuals with CLBP and pain-related fear of movement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109218 0
Dr Peter Window
Address 109218 0
Physiotherapy Department
Level 2, Ned Hanlon Building
Butterfield St
Royal Brisbane and Women's Hospital
Herston, QLD 4006
Country 109218 0
Australia
Phone 109218 0
+61 736464214
Fax 109218 0
Email 109218 0
peter.window@health.qld.gov.au
Contact person for public queries
Name 109219 0
Peter Window
Address 109219 0
Physiotherapy Department
Level 2, Ned Hanlon Building
Butterfield St
Royal Brisbane and Women's Hospital
Herston, QLD 4006
Country 109219 0
Australia
Phone 109219 0
+61 7 36464214
Fax 109219 0
Email 109219 0
peter.window@health.qld.gov.au
Contact person for scientific queries
Name 109220 0
Peter Window
Address 109220 0
Physiotherapy Department
Level 2, Ned Hanlon Building
Butterfield St
Royal Brisbane and Women's Hospital
Herston, QLD 4006
Country 109220 0
Australia
Phone 109220 0
+61 736464214
Fax 109220 0
Email 109220 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?
After de-identification individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case-by-case basis at the discretion of the Co-ordinating Principal Investigator
Available for what types of analyses?
Aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator, Peter Window
peter.window@health.qld.gov.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3889Basic resultsNo 381540-(Uploaded-26-04-2024-11-11-47)-Basic results summary.docx
4161Plain language summaryNo This study aimed to evaluate the effect of combini... [More Details]

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