None listed
Conditions
Brief summary
Aims 1. To determine whether a virtual reality (VR) application results in a significant reduction in pain in people with neuropathic pain following a spinal cord injury; and 2. To determine if the use of VR and changes in pain intensity or negative related perception of pain are associated with corresponding changes in electroencephalographic (EEG) patterns linked to the presence of neuropathic pain. Hypotheses 1. That using a VR application will reduce pain intensity or negative pain-related perceptions in people with neuropathic pain following spinal cord injury 2. That reductions in neuropathic pain using a VR application will be associated with a shift of EEG activity from a dysrhythmic brain wave pattern towards a normal brain wave alert state. Significance Evidence now shows that distraction type VR is useful for people with persistent pain who have difficulty diverting their attention away from ongoing pain by enhancing the level of immersion within a distracting environment. Given that meta-analysis shows no difference in effect between specifically developed computer software and commercially available packages, VR is becoming increasingly affordable and available for use in both clinical and experimental settings. Despite growing evidence of benefit and increased accessibility and affordability, there are no studies that have examined the effectiveness of distraction type VR in people with pain following spinal cord injury. The ability for patients to individually reduce the intensity of their neuropathic pain using affordable VR software would be a major advance for people who currently face major challenges in obtaining satisfactory relief of their pain. Methods Using a randomised crossover design, people with a spinal cord injury and a diagnosis of chronic neuropathic pain will undergo two 20-minute intervention sessions with a one-hour washout period between sessions. One session (active intervention) will comprise the use of immersive VR exploring a scene using an Oculus headset attached to a laptop. The alternate session (control intervention) will comprise viewing the same scene but directly watching the laptop screen. During each VR session, EEG recordings will be obtained from several cortical sites allowing analysis of cortical regions associated with neuropathic pain. In addition, the numerical rating of pain intensity, previously validated self-reporting measures determining psychological function known to influence pain severity such as depression, anxiety, stress, pain self-efficacy and pain catastrophising will be administered before and after each intervention. Benefit VR applications may be a feasible method for reducing long-term pain in people with SCI. Given encouraging experimental findings using not only specifically developed computer software but more importantly, affordable commercially available VR applications, we propose that people with SCI can use VR immersion to override pain and negative emotions and thoughts associated with SCI.
Interventions
1) Concerning the immersive intervention, participants will use Oculus Rift ® headsets to view and interact in an immersive virtual reality (VR) application. Using an easy-to-use hand-held touch controller, participants are able to move around a summer meadow environment (Nature Trek VR®) using simple hand movements that govern direction and speed.
2) This study consists of a single session only where participants take part in two 15 minute VR applications separated by a 60 minute washout per
1) Concerning the immersive intervention, participants will use Oculus Rift ® headsets to view and interact in an immersive virtual reality (VR) application. Using an easy-to-use hand-held touch controller, participants are able to move around a summer meadow environment (Nature Trek VR®) using simple hand movements that govern direction and speed. 2) This study consists of a single session only where participants take part in two 15 minute VR applications separated by a 60 minute washout period. 3) During the set up period immediately prior to the start of the intervention, participants will be shown how to control their movement and speed within the VR environment. During the intervention, researchers will supervise both immersive VR and non-immersive computer display experiences in order to ensure participants are using the hand held devices correctly and to help if they get into difficulty using the hand-held devices
Sponsors
Greenwich Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Spinal cord injury • Male • Tetraplegic (C5 and below) and paraplegic patients. • Complete and incomplete injuries (as determined using the American Spinal Injury Association (ASIA) Impairment Classification) • At least 12 months following injury • A diagnosis of neuropathic pain • Pain intensity equal to or more than 4/10 on the numerical pain rating scale
Exclusion criteria
• The presence of acute pain at the time of the study • High-level complete lesion at C4 and above (due to complexity of assisted technology) • Brain injury or other neurological diagnosis that would affect EEG activity or prevent participants from understanding experimental tasks (e.g. dementia).
Outcome results
None listed