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Cognitive Behavioural Therapy-informed Virtual Reality (VR-CBT) for low back pain

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001184561
Enrollment
40
Registered
2024-09-27
Start date
2024-10-28
Completion date
2025-08-25
Last updated
2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Current conservative treatment approaches for persistent low back pain are effective, but significant waiting periods and healthcare resource strain is common. Virtual reality interventions are showing clear potential in individuals with low back pain populations and could facilitate early self-management. Our previous cohort study demonstrated that combining virtual reality with pain education using cognitive behavioural principles (VR-CBT) leads to clinically significant short-term reductions in pain and fear of movement. While these results are promising, the study lacked a control and was conducted over only 2 sessions. This project addresses the next stage. We will undertake a feasibility RCT (VR-CBT and homebased VR gameplay and mindfulness vs usual care) over a longer intervention period (up to 16 sessions over 4 weeks) to determine the feasibility and primary outcome measure of a future, fully powered RCT evaluating the clinical and cost-effectiveness of longer-duration VR-CBT in the management of persistent low back pain.

Interventions

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. Pai

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.

Sponsors

Royal Brisbane and Women's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026