Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000959279
Ethics application status
Approved
Date submitted
9/05/2018
Date registered
6/06/2018
Date last updated
16/03/2020
Date data sharing statement initially provided
31/10/2018
Date results information initially provided
16/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual-reality as a treatment for pain in people with spinal cord injury
Scientific title
The effects of virtual reality on pain intensity and brain activity in people with neuropathic pain following spinal cord injury
Secondary ID [1] 294759 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury 307657 0
Condition category
Condition code
Neurological 306722 306722 0 0
Studies of the normal brain and nervous system
Injuries and Accidents 306844 306844 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 301061 0
Rehabilitation
Intervention code [2] 301062 0
Treatment: Devices
Comparator / control treatment
For the control, participants will watch the same 15 minute VR experience on a computer screen (“flat”/non-3D).

This control intervention is one of two 15 minute VR applications separated by a 60 minute washout period over one session only.

As stated above, both immersive and non-immersive VR experiences will be supervised by researchers
Control group
Active

Outcomes
Primary outcome [1] 305722 0
Numerical pain rating scale
Timepoint [1] 305722 0
To account for circadian influences on wakefulness in people with SCI, all study interventions will take place between 10.00am and 1.00pm. We will use a randomised crossover design. One hour will be required to collect baseline information, administer questionnaires and familiarise the participant with the VR set-up.

The participant will then undergo two interventions in randomised order. Each intervention will be 15 minutes duration with a 60-minute washout period between interventions.

Numerical pain ratings (11-point scale) will be gained directly after treatment and control interventions
Secondary outcome [1] 346253 0
This is a composite secondary outcome. Linear and non-linear EEG analyses will be performed to determine relationships between brain wave changes, neuropathic pain and influence of virtual reality. EMOTIV EPOC+, 14 channel wireless EEG recordings and will evenly cover cortical sites, allowing analysis of cortical regions that may be involved with neuropathic pain. EEG signals will be sampled at 512Hz and signals will be analysed in specific spectral bands.
Timepoint [1] 346253 0
EEG data will be gained over the course of each 15 minute treatment and control session,
Secondary outcome [2] 346254 0
This is a composite secondary outcome. The Igroup Presence Questionnaire (IPQ) is a scale for measuring the sense of presence experienced in a virtual environment (VE) with the following factors
1) Spatial Presence - the sense of being physically present in the VE
2) Involvement - measuring the attention devoted to the VE and the involvement experienced
3) Experienced Realism - measuring the subjective experience of realism in the VE
Timepoint [2] 346254 0
The Igroup Presence Questionnaire will be used within five minutes of completing both treatment and control interventions

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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).

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 concealment will be done using sealed opaque envelopes
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated using data previous studies and also from a recent meta-analysis on studies investigating the use of VR distraction on clinical and experimental pain, especially those relating to VR programs versus games. Based on these data, we estimate an effect size of .69 and a standard deviation of pre-post change scores of 1.0. Here calculations produce a sample size of 16 per group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/02/2019
Actual
2/05/2019
Date of last participant enrolment
Anticipated
15/12/2019
Actual
24/09/2019
Date of last data collection
Anticipated
15/12/2019
Actual
24/09/2019
Sample size
Target
16
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10877 0
Greenwich Hospital - Greenwich
Recruitment postcode(s) [1] 22622 0
2065 - Greenwich

Funding & Sponsors
Funding source category [1] 299364 0
Charities/Societies/Foundations
Name [1] 299364 0
Australian and New Zealand College of Anaesthetists
Country [1] 299364 0
Australia
Primary sponsor type
Hospital
Name
Greenwich Hospital
Address
Greenwich Hospital is the primary sponsor site where the research will take place.

79-115 River road, Greenwich, 2065, NSW
Country
Australia
Secondary sponsor category [1] 298640 0
Charities/Societies/Foundations
Name [1] 298640 0
HammondCare Health and Hospitals
Address [1] 298640 0
97-115 River Road, Greenwich, 2065, NSW
Country [1] 298640 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300267 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 300267 0
NSLHD Research Office
Level 13, Kolling Building
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 300267 0
Australia
Date submitted for ethics approval [1] 300267 0
15/05/2018
Approval date [1] 300267 0
29/08/2018
Ethics approval number [1] 300267 0

Summary
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.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83098 0
Prof Philip Siddall
Address 83098 0
Pain Management Department, Greenwich Hospital, 97-115 River Road. Greenwich, 2065, NSW
Country 83098 0
Australia
Phone 83098 0
+61 2 8788 3941
Fax 83098 0
Email 83098 0
[email protected]
Contact person for public queries
Name 83099 0
Dr Philip Austin
Address 83099 0
Pain Management Department, Greenwich Hospital, 97-115 River Road. Greenwich, 2065, NSW
Country 83099 0
Australia
Phone 83099 0
+61 2 8878 3943
Fax 83099 0
Email 83099 0
[email protected]
Contact person for scientific queries
Name 83100 0
Dr Philip Austin
Address 83100 0
Pain Management Department, Greenwich Hospital, 97-115 River Road. Greenwich, 2065, NSW
Country 83100 0
Australia
Phone 83100 0
+61 2 8878 3943
Fax 83100 0
Email 83100 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
no current decision concerning data availability


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
SourceTitleYear of PublicationDOI
EmbaseThe short-term effects of head-mounted virtual-reality on neuropathic pain intensity in people with spinal cord injury pain: a randomised cross-over pilot study.2021https://dx.doi.org/10.1038/s41393-020-00569-2
N.B. These documents automatically identified may not have been verified by the study sponsor.