Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001170112
Ethics application status
Approved
Date submitted
2/08/2019
Date registered
20/08/2019
Date last updated
3/02/2022
Date data sharing statement initially provided
20/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual reality for chronic pain patients: A pilot study
Scientific title
Virtual reality to improve function in chronic pain patients: A pilot study
Secondary ID [1] 298916 0
Nil Known
Universal Trial Number (UTN)
U1111-1234-0487
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 313892 0
Condition category
Condition code
Musculoskeletal 312309 312309 0 0
Other muscular and skeletal disorders
Neurological 312422 312422 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Thirty chronic pain patients that have been assessed by The Auckland Regional Pain Service (TARPS) and waitlisted for physiotherapy treatment will be invited to take part in the study. Those who chose to take part will be randomly assigned to either a 6-week virtual reality (VR) intervention, or to a control group that will receive standard physiotherapy/treatment as usual.

The intervention will consist of twice-weekly, 30-minute VR sessions, across 6-weeks (totalling 12 sessions). Each VR session will be a one-on-one, face-to-face treatment delivered by a physiotherapist. Participants will wear a VR head mounted display and hand sensors. Participants will be guided by the treating physiotherapist to play games that require moving in a virtual environment. The gamification software for this study have been graded from ‘0 = minimal difficulty’ to ‘6 = very difficult’ based on required range and speed of motion. All participants will start on grade 1, and will progress through the grades at the discretion of the treating physiotherapist.

Following the VR intervention, ten participants will be invited to complete semi-structured interviews. To monitor adherence to the intervention records will be kept regarding the number of VR appointments that each participant completes.

Participants in the intervention group will also complete physical capacity evaluations (PCE) and questionnaires assessing pain severity, disability, and fear of movement at baseline, and at the completion of the intervention. Objective measures of physical activity, both during the VR treatment and in daily life, will be collected using activity tracking devices. These will be worn by participants in the VR group for the duration of the first and sixth weeks of the VR trial.
Intervention code [1] 315195 0
Rehabilitation
Intervention code [2] 315294 0
Treatment: Other
Comparator / control treatment
The control group will receive standard care, which is a six week waitlist followed by 12 weeks of once-weekly physiotherapy treatment. Participants in the control group will complete baseline questionnaires and follow-up questionnaires at the end of the six week waitlist (prior to physiotherapy treatment), and 6 weeks after beginning standard physiotherapy treatment. Participants in the control group will be given activity trackers to wear for the first and last week of the six week waitlist time.
Control group
Active

Outcomes
Primary outcome [1] 320945 0
Change in pain scores in the VR group as assessed by the Brief Pain Inventory, Short Form (BPI); (Cleeland, 1989; Cleeland & Ryan, 1994)
Timepoint [1] 320945 0
Assessed at the completion of the 6 week intervention
Primary outcome [2] 321074 0
Change in objective physical function in the VR group as assessed by participant time to complete a standardised 50m speed-walk test
Timepoint [2] 321074 0
Assessed at the completion of the 6 week intervention
Primary outcome [3] 321075 0
Change in activity level during the VR treatment sessions as assessed by an activPAL (TM) activity tracking device. Activity levels from the final two VR treatment sessions in week 6 of the intervention will be averaged.
Timepoint [3] 321075 0
The final week of the 6 week intervention
Secondary outcome [1] 373455 0
Change in fear of movement in the VR group as assessed by the TAMPA scale of kinesiophobia (TAMPA; Miller, Kori, Shashidar & Dennis, 1991).
Timepoint [1] 373455 0
At the end of the 6 week intervention
Secondary outcome [2] 373886 0
Difference in pain scores between the intervention group and the treatment as usual group as assessed by the Brief Pain Inventory, Short Form (BPI); (Cleeland, 1989; Cleeland & Ryan, 1994)
Timepoint [2] 373886 0
Comparisons will be made between the treatment group at the end of the 6 week VR intervention and the control group at two time points;
1) at the end of the 6 week waitlist (i.e. VR vs no treatment), and
2) at the end of 6 weeks of physiotherapy (i.e. VR vs treatment as usual).
Secondary outcome [3] 373889 0
Intervention evaluation by the VR group as assessed by the Patient Global Impression of Change Scale (PGIC; Guy, 1976).
Timepoint [3] 373889 0
At the end of the six week intervention
Secondary outcome [4] 373890 0
Semi structured interviews: The first 10 participants to complete 12 VR sessions will undergo semi-structured interviews with a trained, post-graduate physiotherapy student. Interviews will be audio-recorded and transcribed.
Timepoint [4] 373890 0
At the end of the six week intervention
Secondary outcome [5] 373891 0
Change in Objective Function in the VR group assessed by a standardised Dynamic Lift assessment which measures the ability lift objects.
Timepoint [5] 373891 0
At the end of the six week intervention
Secondary outcome [6] 373892 0
Participant retention rates will be assessed by recording the number of VR treatment sessions attended over the 6 week treatment time
Timepoint [6] 373892 0
A the end of the 6 week intervention
Secondary outcome [7] 373893 0
Change in general activity levels in the VR participants throughout the week between week 1 and week 6 of the intervention as assessed by an activpal (TM) activity tracking device
Timepoint [7] 373893 0
At the completion of the 6 week intervention

Eligibility
Key inclusion criteria
(1) experiencing musculoskeletal pain
(2) ability to complete a 6-week active rehabilitation intervention
(3) expect to have stable medication for the duration of the trial
(4) between the ages of 18 and 70
(5) residing in Auckland
(6) ability to communicate in English.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) severe medical or psychiatric conditions
(2) non-musculoskeletal pain (neural, headache, abdominal pain)
(3) they experience motion sickness
(4) they are taking part in pain treatment outside of The Auckland Regional Pain Service
(TARPS)
(5) their treatment at TARPS is being funded by the Accident Compensation Corporation (ACC)
(6) if they are unavailable for the duration of the intervention and follow-up period.

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 involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using an online random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size for the present pilot study is based on the calculated sample size for the main trail. Based on power analysis using G-power software (3.0.10) it was found that for a power of .90 and alpha of .05, 104 participants would be needed to detect a small to medium effect size using repeated-measures analysis of variance (ANOVA). Based on this analysis, stepped rules of thumb indicate that a sample of N=15 for the treatment arm is sufficient to achieve 90% power for the pilot study (Whitehead et al, 2016). A further 15 participants (total N = 30) will be recruited for the TAU control.

Data will be analysed using SPSS version 25. Baseline characteristics will be analysed using descriptive statistics where appropriate given the small sample size. Because this is a feasibility study, significance testing will not be conducted, instead Hedges G relative effect sizes for all outcome measures will be computed, and used to estimate appropriate sample sizes for an adequately powered RCT using GPower software with an alpha of 0.05, and a power of 0.95.

Qualitative analysis of participant feedback and semi-structured interviews will be used to develop the intervention for the planned RCT comparing a VR intervention with standard physiotherapy treatment.




Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/09/2019
Actual
1/10/2019
Date of last participant enrolment
Anticipated
9/12/2019
Actual
31/12/2020
Date of last data collection
Anticipated
9/03/2020
Actual
31/03/2021
Sample size
Target
30
Accrual to date
Final
21
Recruitment outside Australia
Country [1] 21739 0
New Zealand
State/province [1] 21739 0
Auckland

Funding & Sponsors
Funding source category [1] 303462 0
University
Name [1] 303462 0
Internal Funding Auckland University of Technology (AUT)
Country [1] 303462 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Health & Rehabilitation Research Institute
Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland
0627
Country
New Zealand
Secondary sponsor category [1] 303639 0
None
Name [1] 303639 0
Address [1] 303639 0
Country [1] 303639 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303993 0
Health and Disability Ethics Committee
Ethics committee address [1] 303993 0
Ethics committee country [1] 303993 0
New Zealand
Date submitted for ethics approval [1] 303993 0
Approval date [1] 303993 0
01/07/2019
Ethics approval number [1] 303993 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95482 0
Dr Natalie Tuck
Address 95482 0
Health & Rehabilitation Research Institute
Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland
0627
Country 95482 0
New Zealand
Phone 95482 0
+64 212669363
Fax 95482 0
Email 95482 0
[email protected]
Contact person for public queries
Name 95483 0
Natalie Tuck
Address 95483 0
Health & Rehabilitation Research Institute
Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland
0627
Country 95483 0
New Zealand
Phone 95483 0
+64 212669363
Fax 95483 0
Email 95483 0
[email protected]
Contact person for scientific queries
Name 95484 0
Natalie Tuck
Address 95484 0
Health & Rehabilitation Research Institute
Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland
0627
Country 95484 0
New Zealand
Phone 95484 0
+64 212669363
Fax 95484 0
Email 95484 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data collected during the trial
When will data be available (start and end dates)?
Beginning 3 months following main results publication, no end date determined.
Available to whom?
On a case-by-case basis at the discretion of the primary investigator
Available for what types of analyses?
Any purpose
How or where can data be obtained?
By emailing the primary investigator; [email protected]


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.