Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000700538
Ethics application status
Approved
Date submitted
23/05/2024
Date registered
4/06/2024
Date last updated
4/06/2024
Date data sharing statement initially provided
4/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Usability and acceptability of a virtual reality treatment for complex regional pain syndrome in adults
Scientific title
Usability and acceptability of a virtual reality intervention for complex regional pain syndrome in adults
Secondary ID [1] 312179 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complex regional pain syndrome 333834 0
Condition category
Condition code
Anaesthesiology 330509 330509 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend 4 x 30-minute individual face-to-face intervention sessions over 2 weeks in a clinical environment. For ~15 minutes at the end of each intervention session, participants will use a Meta Quest 3 virtual reality headset to view a 3-dimensional model of their upper limbs while in a virtual environment and, using a custom-designed software application, be able to manipulate the size, transparency, and colour of their (virtual) affected limb, according to their individual preferences. Once the appearance of the virtual limb has been adjusted to their satisfaction, participants will spend 5 minutes viewing and attending to the (visually altered) virtual limb under the guidance of a New Zealand registered specialist pain physiotherapist. During this time they will be asked by the physiotherapist to perform simple functional movements of their affected hand and/or arm, which will be reflected by the virtual limb (e.g. making a fist). These movements will be individually tailored for each participant by the physiotherapist. A session attendance checklist will be used to monitor adherence.
Intervention code [1] 328622 0
Treatment: Other
Intervention code [2] 328623 0
Rehabilitation
Intervention code [3] 328624 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338275 0
Usability
Timepoint [1] 338275 0
1. Semi-structured interview with participants: After 1st and 4th intervention sessions.
2. Task completion index: After 1st intervention session.
3. Semi-structured interview with physiotherapist: At trial completion, after all participants have completed the intervention.
Primary outcome [2] 338276 0
Acceptability
Timepoint [2] 338276 0
1. Semi-structured interview with participants: After 1st and 4th intervention sessions.
2. Semi-structured interview with physiotherapist: At trial completion, after all participants have completed the intervention.
3. Acceptability questionnaire: After 4th intervention session.
Secondary outcome [1] 435246 0
Average pain intensity in the complex regional pain syndrome (CRPS)-affected limb in the last 24 hours.
Timepoint [1] 435246 0
Daily, from 7 days before the baseline assessment to Day 28 (post-intervention follow-up).
Secondary outcome [2] 435247 0
Average pain unpleasantness in the CRPS-affected limb in the last 24 hours.
Timepoint [2] 435247 0
Daily, from 7 days before the baseline assessment to Day 28 (post-intervention follow-up).
Secondary outcome [3] 435248 0
Pain Interference
Timepoint [3] 435248 0
Day 1 (baseline/pre-intervention), Day 14 (post-intervention) and Day 28 (post-intervention follow-up)
Secondary outcome [4] 435249 0
Psychological distress
Timepoint [4] 435249 0
Day 1 (pre-intervention), Day 14 (post-intervention), Day 28 (post-intervention follow-up)
Secondary outcome [5] 435250 0
Body Perceptual Disturbances
Timepoint [5] 435250 0
Day 1 (pre-intervention), Day 14 (post-intervention), Day 28 (post-intervention follow-up)
Secondary outcome [6] 435251 0
Perceptual changes in CRPS-affected hand
Timepoint [6] 435251 0
Day 1 (pre-intervention), Day 14 (post-intervention), Day 28 (post-intervention follow-up), and also immediately before and immediately after 5 minute VR intervention in all 4 intervention sessions.
Secondary outcome [7] 435392 0
Neglect like symptoms
Timepoint [7] 435392 0
Day 1 (pre-intervention), Day 14 (post-intervention), Day 28 (post-intervention follow-up), and also immediately before and immediately after 5 minute VR intervention in all 4 intervention sessions.
Secondary outcome [8] 435393 0
Current pain intensity in the CRPS-affected limb
Timepoint [8] 435393 0
Immediately before and immediately after 5 minute VR intervention in all 4 intervention sessions.
Secondary outcome [9] 435394 0
Current pain unpleasantness in the CRPS-affected limb.
Timepoint [9] 435394 0
Immediately before and immediately after 5 minute VR intervention in all 4 intervention sessions.
Secondary outcome [10] 435395 0
Limb circumference
Timepoint [10] 435395 0
Immediately before and immediately after 5 minute VR intervention in all 4 intervention sessions.
Secondary outcome [11] 435396 0
Limb temperature
Timepoint [11] 435396 0
Immediately before and immediately after 5 minute VR intervention in all 4 intervention sessions.
Secondary outcome [12] 435397 0
Treatment emergent adverse events
Timepoint [12] 435397 0
Participants will be explicitly questioned about any adverse events experienced at each intervention session.

Eligibility
Key inclusion criteria
1. Aged 18 or over
2. Pain intensity greater than or equal to 4/10 on average in the last week
3. Formal diagnosis of CRPS in one upper limb only as per Budapest clinical criteria
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any co-morbidity that might affect CRPS symptoms (e.g. stroke, diabetes, fibromyalgia)
2. Inability to communicate in English
3. A history of severe motion sickness, epilepsy or (uncorrected) visual impairment

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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/06/2024
Actual
Date of last participant enrolment
Anticipated
4/11/2024
Actual
Date of last data collection
Anticipated
2/12/2024
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment outside Australia
Country [1] 26332 0
New Zealand
State/province [1] 26332 0

Funding & Sponsors
Funding source category [1] 316546 0
Government body
Name [1] 316546 0
Te Titoki Mataora
Country [1] 316546 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Country
New Zealand
Secondary sponsor category [1] 318756 0
None
Name [1] 318756 0
Address [1] 318756 0
Country [1] 318756 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315339 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 315339 0
https://ethics.health.govt.nz/about/central-health-and-disability-ethics-committee/
Ethics committee country [1] 315339 0
New Zealand
Date submitted for ethics approval [1] 315339 0
16/04/2024
Approval date [1] 315339 0
08/05/2024
Ethics approval number [1] 315339 0

Summary
Brief summary
This single arm, open-label intervention study in people with complex regional pain syndrome (CRPS) affecting their hand/arm will assess the usability and acceptability of new custom-designed virtual reality software that allows the user to alter the size, colour and transparency of their (virtual) limb when viewing it through a Meta Quest 3 virtual reality headset. All participants will receive 4 virtual reality treatment sessions over a 2 week period under the guidance of a specialist pain physiotherapist. Questionnaires and semi-structured interviews with participants and the physiotherapist will be used to evaluate the usability and acceptability of the new virtual reality treatment. In addition, initial information about how the virtual reality treatment changes signs and symptoms of CRPS (e.g. pain intensity, the way the arm feels and hand swelling and temperature) will be collected before and after each intervention session, during the 2 week treatment period, and during a 2 week follow up period, after the treatment has finished.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134390 0
Dr Debbie Bean
Address 134390 0
Auckland University of Technology, 90 Akoranga Drive, Northcote, Auckland
Country 134390 0
New Zealand
Phone 134390 0
+6499217157
Fax 134390 0
Email 134390 0
debbie.bean@aut.ac.nz
Contact person for public queries
Name 134391 0
Debbie Bean
Address 134391 0
Auckland University of Technology, 90 Akoranga Drive, Northcote, Auckland
Country 134391 0
New Zealand
Phone 134391 0
+6499217157
Fax 134391 0
Email 134391 0
debbie.bean@aut.ac.nz
Contact person for scientific queries
Name 134392 0
Debbie Bean
Address 134392 0
Auckland University of Technology, 90 Akoranga Drive, Northcote, Auckland
Country 134392 0
New Zealand
Phone 134392 0
+6499217157
Fax 134392 0
Email 134392 0
debbie.bean@aut.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be publicly available as 1) participants have not consented to this, and 2) to protect potential intellectual property.


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
No additional documents have been identified.