ANZCTR - Registration

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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

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Spinal cord injury

Condition category

Condition code

Neurological

Studies of the normal brain and nervous system

Injuries and Accidents

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]

Rehabilitation

Intervention code [2]

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]

Numerical pain rating scale

Timepoint [1]

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]

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]

EEG data will be gained over the course of each 15 minute treatment and control session,

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Greenwich Hospital - Greenwich

Recruitment postcode(s) [1]

2065 - Greenwich

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian and New Zealand College of Anaesthetists

Address [1]

ANZCA House,
630 St Kilda Road,
Melbourne, Victoria 3004,

Country [1]

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]

Charities/Societies/Foundations

Name [1]

HammondCare Health and Hospitals

Address [1]

97-115 River Road, Greenwich, 2065, NSW

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

NSLHD Research Office
Level 13, Kolling Building
Royal North Shore Hospital
St Leonards NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/05/2018

Approval date [1]

29/08/2018

Ethics approval number [1]

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

Prof Philip Siddall

Address

Pain Management Department, Greenwich Hospital, 97-115 River Road. Greenwich, 2065, NSW

Country

Australia

Phone

+61 2 8788 3941

Fax

psiddall@hammond.com.au

Contact person for public queries

Name

Philip Austin

Address

Pain Management Department, Greenwich Hospital, 97-115 River Road. Greenwich, 2065, NSW

Country

Australia

Phone

+61 2 8878 3943

Fax

paustin@hammond.com.au

Contact person for scientific queries

Name

Philip Austin

Address

Pain Management Department, Greenwich Hospital, 97-115 River Road. Greenwich, 2065, NSW

Country

Australia

Phone

+61 2 8878 3943

Fax

paustin@hammond.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	The 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.	2021	https://dx.doi.org/10.1038/s41393-020-00569-2

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically