Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001776190
Ethics application status
Approved
Date submitted
2/12/2019
Date registered
16/12/2019
Date last updated
20/03/2020
Date data sharing statement initially provided
16/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Altering body image in chronic low back pain using virtual reality: A proof of concept randomised clinical trial
Scientific title
Altering body image in chronic low back pain using virtual reality: A proof of concept randomised clinical trial
Secondary ID [1] 299272 0
Nil
Universal Trial Number (UTN)
U1111-1240-1469
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain 314409 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312744 312744 0 0
Physiotherapy
Musculoskeletal 312745 312745 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Body Image-VR
The VR experience will involve three enhanced embodiment experiences: 1. A muscular boxer, 2. A super hero, 3. A rock climber.

Notably, all phases can be performed sitting and/or standing to suit the tolerance of the individual. All components of the intervention will be conducted and/or supervised by a qualified clinician (physiotherapist and/or clinical exercise physiologist).

Three bodily experiences will be completed in a single session with a 5-minute interval between each. At the beginning of each experience the experimenter will assist the user to operate the hand controls and facilitate avatar embodiment by encouraging the user to move and observe their virtual body before talking the participant through the activity. Before, after, and during each experience, participants will rate their perceived strength, vulnerability, agility & confidence (Pain-related Body Image Scale) and pain intensity using 0-10 numerical rating scales. Between each activity participants will exit VR for instruction on the next activity.

Boxing Avatar (6-minutes)
Prior to entering VR, the experimenter will demonstrate a series of ‘muscle poses’ and 'boxing actions' that they will be encouraged to do once in VR to embody the avatar and it's characteristics. When in VR, participants will observe their body, make muscle poses, and interact with a virtual boxing bag.

Rock Climbing Avatar (6-minutes)
Prior to entering VR the experimenter will demonstrate the controls needed to climb. Participants will then scale a virtual cliff by reaching, grasping, and pulling on hand-holds in the cliff face. Immediately prior, during, and immediately following, participants will rate the body image and pain scales.

Super Hero: The Incredible Hulk Avatar (6-minutes)
Prior to entering VR, the experimenter will demonstrate the activity and how to use the controls in order to use the avatars 'special strength powers' that they will perform when in VR. When in VR, participants will do activities such as lift and throw 'heavy' virtual objects and create earth quakes using their 'strength'.

To ensure fidelity to the intervention protocol, a senior researcher from the research team will observe the first three participants from each group.
Intervention code [1] 315557 0
Treatment: Other
Comparator / control treatment
General VR.
Participants in the General VR group will engage with an interactive 3D environments, but without a physically enhanced virtual body. A single clinic-based session of interactive VR will be undertaken using the application 'Job or Vacation Simulator', for 18 minutes (in 3-blocks of 6 minutes). Participants will be placed in vacation and/or work place scenarios and encouraged to explore (e.g. create a virtual painting, build a virtual sand castle, make coffee, photocopy virtual documents) while remaining within normal self-selected movement. The control intervention can be completed in sitting and/or standing to suit the tolerance of the individual. All components of the intervention will be conducted and/or supervised by a qualified clinician (physiotherapist and/or clinical exercise physiologist).
Control group
Active

Outcomes
Primary outcome [1] 321891 0
Change in pain-related body image scale score (average of four numerical ratings of perceived bodily strength, agility, vulnerability, and confidence with activities).
Timepoint [1] 321891 0
1. Pre-VR (immediately before VR)
2. During-VR (rated during, and averaged across, the three 6-minute VR experiences)
3. Post-VR (immediately after VR)
Primary outcome [2] 321892 0
Change in pain on a 0-10 Numerical Rating Scale, where 0=no pain, and 10=the worst imaginable pain.
Timepoint [2] 321892 0
1. Pre-VR (immediately before VR)
2. During-VR (rated during, and averaged across, the three 6-minute VR experiences)
3. Post-VR (immediately after VR)
Secondary outcome [1] 376606 0
Change in pain-related body image scale and pain at 1-week followup, to assess carry-over from a single session.
Timepoint [1] 376606 0
1. Pre-VR (immediately before VR)
2. 1-week followup
Secondary outcome [2] 376607 0
Modified Embodiment Questionnaire (used to assess strength of embodiment which may be modulate other outcomes)
Timepoint [2] 376607 0
1. Post-VR: Modified Embodiment Questionnaire will be assessed during each VR experience.
Secondary outcome [3] 376608 0
Change in strength, measured using a hand-held dynamometer (kg)
Timepoint [3] 376608 0
1. Pre-VR (immediately before VR)
2. During-VR (average of strength during the three VR conditions)
3. Post-VR (immediately after VR)
Secondary outcome [4] 376707 0
Perceived harmfulness of activity (examined with the Photograph Series of Daily Activities (PHODA-SEV)) which uses photographs to determine the threat value of different physical activities and movements.
Timepoint [4] 376707 0
1. Pre-VR (immediately before VR)
2. Post-VR (immediately after VR)
Secondary outcome [5] 376981 0
Qualitative analysis of patient experiences, including:
1. What are patients’ experiences of using VR in the clinical context?
2. To what extent do patients perceive VR as an acceptable, feasible, and tolerable mode of therapy?
4. What are the perceived benefits and detriments of the VR intervention?
5. What facilitators and barriers exist to the future use of VR as a therapy?
Timepoint [5] 376981 0
A semi-structured interview will be undertaken within 7-days following the VR session (intervention group participants only).

Eligibility
Key inclusion criteria
Adults (>18 years of age) who have been referred to the Metro South Health Persistent Pain Management Service (Bourke Street Centre) for the management of chronic low back pain (duration at least 6 months), who have scores of at least “moderate” on questions 7 (“How much bodily pain have you had during the past 4 weeks?”), and question 8 (“During the past 4 weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?”) of the SF-36 (Ware & Sherbourne 1992), are able to read and understand English language, can operate a computer, and are able to provide informed consent, will be eligible for inclusion in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will comprise a diagnosis of, or the presence of red flags indicating, serious spinal pathology (i.e. infection, tumour, recent fracture, significant structural deformity such as unstable/unstabilised spondylolisthesis or progressive scoliosis, inflammatory disorder, and neuropathic radicular syndrome or cauda equina syndrome with clear neurological impairment). Inability to tolerate visual stimulation (i.e. susceptibility to migraines aggravated by light) or inability to tolerate the head mounted display (i.e. sensitivity to touch around the face and head) will also result in exclusion.

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)
Clinicians will refer patients to the study and the experimenter will then make contact with participants by phone to provide information and arrange an appointment. These steps will occur prior to group allocation, and as such neither the clinician nor the experimenter will have knowledge of group allocation before the day of the experiment. On the day of testing, the experimenter will open a sealed opaque envelope, pre-prepared by a third party, containing the participants allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A concealed allocation approach will be employed, where participants are allocated to the intervention or control croup with a 2:1 ratio. The random allocation sequence will be generated using Microsoft excel by an experimenter not involved in data collection. The allocation of participants 1-30 will then be recorded on dark, non-transparent card, and inserted into opaque envelopes that will be numbered consecutively.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
A limited deception approach is used to maintain participant blinding. While participants understand they will be randomised to one of two groups, the existence of a 'control' group is with-held. That is, both groups understand that they will be trying a type of virtual reality that may have clinic effects. This is only limited deception, since we expect some effect of both 'types' of virtual reality, at least in the short-term.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary research questions:
Question1: Is there an effect of VR body illusion on body image scale score
Analysis: Mixed model 2(Group: Body Image-VR vs. General-VR) x 3(Time: Pre-VR vs. during-VR vs. post-VR) ANOVA.

Question2: Is there an effect of VR body illusion on current pain
Analysis: Mixed model 2(Group: Body Image-VR vs. General-VR) x 3(Time: Pre-VR vs. during-VR vs. post-VR) ANOVA

Secondary research questions
Question3: Is there an effect of VR body illusion at 1-week followup on body image scale score, perceived harmfulness of activity (PHODA) or pain (NRS) at 1-week follow up?
Analysis: Mixed model 2(Group: Body Image-VR vs. General-VR) x 2(Time: Pre-VR vs. 1-week followup) ANOVA for each outcomes.

Question4: Is there an effect of VR body illusion on strength
Analysis: Mixed model 2(Group: Body Image-VR vs. General-VR) x 3(Time: Pre-VR vs. during-VR vs. post-VR) ANOVA

Question5: Does change in primary outcome depend on strength of virtual avatar embodiment during VR
Analysis: Series of linear regression comparing Modified Embodiment Questionnaire score, and change (pre-VR vs. post-VR) for each of the primary outcomes.

Question6: Is there an effect of VR body illusions on perceived harmfulness of activity (PHODA)
Analysis: Mixed model 2(Group: Body Image-VR vs. General-VR) x 2(Time: Pre-VR, vs. post-VR) ANOVA

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/03/2020
Actual
Date of last participant enrolment
Anticipated
25/05/2020
Actual
Date of last data collection
Anticipated
8/06/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15109 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 28404 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 303806 0
Other Collaborative groups
Name [1] 303806 0
The Hopkins Centre
Country [1] 303806 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
1 Parklands Dr, Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 303927 0
Hospital
Name [1] 303927 0
Princess Alexandra Hospital
Address [1] 303927 0
199 Ipswich Road, Woolloongabba, QLD
Country [1] 303927 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304323 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 304323 0
Metro South Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 304323 0
Australia
Date submitted for ethics approval [1] 304323 0
12/09/2019
Approval date [1] 304323 0
30/10/2019
Ethics approval number [1] 304323 0
HREC/2019/QMS/53077

Summary
Brief summary
A randomised controlled proof of concept and feasibility study will investigate whether virtually embodying hyper-muscular and hyper-capable avatars in virtual reality (VR) can augment body image as it relates to the perception of bodily integrity and vulnerability, and whether these changes relate to short-term improvements in clinical outcomes. Thirty adults with chronic low back pain will be recruited from the Metro South Health Persistent Pain Management Service and randomised to receive a single session VR intervention targeting body image ‘Body Image-VR’ (n=20), or single session of general virtual reality ‘General-VR’ (n=10). Primary outcome measures of body image, pain, and strength, will be assessed: (1) Immediately pre- and post-intervention, and (2) At one week follow-up to assess carry-over effects. A qualitative interview will be conducted with Intervention participants to investigate VR experience, acceptability, feasibility, and tolerability. We hypothesise that embodying hyper-capable avatars in VR will improve body image, pain and strength. We expect outcomes to inform future research and clinical implementation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96538 0
Dr Daniel Harvie
Address 96538 0
Griffith University
Room G05_2.44A
1 Parklands Dr, Southport QLD 4215
Country 96538 0
Australia
Phone 96538 0
+61755527898
Fax 96538 0
Email 96538 0
[email protected]
Contact person for public queries
Name 96539 0
Dr Daniel Harvie
Address 96539 0
Griffith University
Room G05_2.44A
1 Parklands Dr, Southport QLD 4215
Country 96539 0
Australia
Phone 96539 0
+61 755527898
Fax 96539 0
Email 96539 0
[email protected]
Contact person for scientific queries
Name 96540 0
Dr Daniel Harvie
Address 96540 0
Griffith University
Room G05_2.44A
1 Parklands Dr, Southport QLD 4215
Country 96540 0
Australia
Phone 96540 0
+61 755527898
Fax 96540 0
Email 96540 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 primary and secondary outcome data for each participant will be available on request.
When will data be available (start and end dates)?
Data will be available following publication. Estimated start date: 1/12/2020. No end date determined.
Available to whom?
Researchers with justification.
Available for what types of analyses?
Meta-analyses, exploratory analyses.
How or where can data be obtained?
By email request: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5564Study protocol  [email protected]
5565Clinical study report  [email protected]
5566Ethical approval  [email protected] 378370-(Uploaded-06-11-2019-11-46-38)-Study-related document.pdf



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.