Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000107325
Ethics application status
Approved
Date submitted
13/01/2017
Date registered
19/01/2017
Date last updated
19/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
MoOVi-therapy: Using illusory virtual reality exercises to treat neck pain
Scientific title
MoOVi-therapy: Using illusory virtual reality exercises to treat neck pain
Secondary ID [1] 290727 0
Nil
Universal Trial Number (UTN)
U1111-1190-8259
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neck pain 301304 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301057 301057 0 0
Physiotherapy
Musculoskeletal 301352 301352 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study consists of four phases - 1. Baseline phase (pain intensity and movement-evoked pain threshold measurements are collected but no intervention is performed), 2. Control phase (pain intensity and movement-evoked pain threshold measurements are collected AND exercises are performed in virtual reality but WITHOUT the illusion applied, 3. the Intervention phase (pain intensity and movement-evoked pain threshold measurements are performed AND exercises are performed in virtual reality WITH the MoOVi illusion applied, and 4. Follow-up phase (pain intensity and movement-evoked pain threshold measurements are collected but no intervention is performed). Since the power of the statistical approach to analysing multiple baseline designs depends on randomisation of phase start-points/durations (and the number of points available for randomisation), the length of each phase will be randomised for each participant within set duration parameters. These are duration parameters are: Baseline phase (5-14days), Control phase (5-14days), Intervention phase (21-28days), Follow-up phase (5-14 days). In addition the start time (morning or afternoon) is also randomised. These phase durations/start points are determined a-priori and randomly allocated among participants.

Experimental Intervention: Head rotation exercises will be performed in virtual reality with a progressive visual illusion that increasingly suggests their pain-free movement is increasing towards a more normal, pain-free range.

Location: Initial assessment and instruction will be given at Recover Injury Research Centre by a physiotherapist. Subsequent measurement and exercise is conducted independently by the participant in their own home.

Equipment: The treatment will be delivered using a Samsung Gear VR headset, and a Samsung Galaxy s7 smartphone as the installed display. The VR application running the virtual reality is the custom build MoOVi therapy application.

Procedure:
1. Participant applies the virtual reality headset.
2. Participant follows the on-screen instructions to ‘turn to the first onset of pain in each direction’ to measure movement-evoked pain threshold.
3. The head mounted display then instructs the patient to move following a tracer inside the virtual world. The tracer will control movement to within real-world pain-free range of motion while gradually increasing the range of virtual movement (through progressively exaggerated visual feedback). Movements will include 2 sets of 10 repetitions of head rotation repeated twice per day (=40 repetitions per day).
4. In-between sets, and at the end of the session participants again follow the on-screen instructions to ‘turn to the first onset of pain in each direction’ to measure movement-evoked pain threshold.

During a 1 x 1 hour session at the beginning of the study, a physiotherapists will teach the participant the exercise regime in person. Once taught, the participant will execute the regime independently.

Adherence is assessed by a digital log that records all exercise session. This also aids to enhance adherence since participants are aware that sessions are recorded.
Intervention code [1] 296627 0
Rehabilitation
Intervention code [2] 296628 0
Treatment: Other
Intervention code [3] 296883 0
Treatment: Devices
Comparator / control treatment
The control treatment will precisely mimic the experimental intervention, except that the virtual reality will not exaggerate the performed movements.

Procedure:
1. Participant applies the virtual reality headset.
2. Participant follows the on-screen instructions to ‘turn to the first onset of pain in each direction’ to measure movement-evoked pain threshold.
3. The head mounted display then instructs the patient to move following a tracer inside the virtual world. The tracer will control movement to within real-world pain-free range of motion and virtual movement will not progressively exaggerate visual feedback. Movements will include 2 sets of 10 repetitions of head rotation repeated twice per day (=40 repetitions per day).
4. In-between sets, and at the end of the session participants again follow the on-screen instructions to ‘turn to the first onset of pain in each direction’ to measure movement-evoked pain threshold.

Duration: As noted, the control treatment will be randomised between 5-14 days duration.
Control group
Active

Outcomes
Primary outcome [1] 300477 0
Movement-evoked pain threshold.

This is assessed using the sensors onboard the Samsung gear VR headset and Galaxy smartphone. On-screen instructions ask the participant to rotate left to the first onset of pain, press a button on the side of the VR headset, and return to centre. This is repeated to the right and then the range of motion for each rotation pain threshold is recorded digitally in a log including a time and date stamp. This is repeated three times at each session, including before and after each set of 10 movements in the control and treatment phases..
Timepoint [1] 300477 0
Movement-evoked pain threshold will be measured twice daily through baseline, placebo, intervention, and follow-up phases. That is, from the commencement of the study, movement evoked-pain threshold is measured twice every single day.

Since we are using a multiple-baseline replicated single case series, the statistical analyses compare trends within the treatment phase relative to control phases.
Primary outcome [2] 300478 0
Pain intensity

Pain intensity is rated using a 0-10 visual analogue scale, and recorded in the symptom diary. The scale includes the anchors 0 = no pain and 10 = the worst imaginable pain.

Ratings for 'worst' and 'average pain' for the day so far, as well as 'pre-' and 'post-exercise session' ratings are recorded.
Timepoint [2] 300478 0
Pain intensity will be measured twice daily through baseline, placebo, intervention, and follow-up phases. That is, from the commencement of the study, movement evoked-pain threshold is measured twice every single day.

Since we are using a multiple-baseline replicated single case series, the statistical analyses compare trends within the treatment phase relative to control phases.
Secondary outcome [1] 330056 0
Neck Disability Index
Timepoint [1] 330056 0
NDI will be measured daily through baseline, placebo, intervention, and follow-up phases. That is, from the commencement of the study, movement evoked-pain threshold is measured twice every single day.

Since we are using a multiple-baseline replicated single case series, the statistical analyses compare trends within the treatment phase relative to control phases.

Eligibility
Key inclusion criteria
The presence of neck pain longer than 3-month.
The presence of pain with head rotation.
The presence of moderate to severe neck pain, as defined by a >3/10 'average pain over the previous week'.
Traumatic (including whiplash associated disorder) and idiopathic cases may be included provided other inclusion criteria are met.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with known or suspected spinal pathology (e.g. metastatic disease of the spine);
confirmed fracture or dislocation at time of injury (whiplash grade IV); concussion or head injury as a result of motor vehicle accident, lack of fluency in spoken and written English insufficient for informed consent and questionnaire completion; Children and/or young people (ie. <18 years); People with an intellectual or mental impairment; People in existing dependent or unequal relationships with any member of the research team, the researcher(s), and/or the person undertaking the recruitment/consent process; Women
who are pregnant; People who's symptoms are unreasonably exacerbated by movement; People with epilepsy; Neurological deficit.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Multiple baseline replicated single case series design.

All subjects will undergo phases: Baseline - Control Intervention - Experimental Intervention - Post-treatment
Phase
Type of endpoint/s
Statistical methods / analysis
“The data of the randomized multiple-baseline design will be analyzed with a randomization test specifically designed for randomized multiple-baseline designs (e.g., Bulté & Onghena, 2009). The sample size needed to achieve a power of at least 80% in the test using a 5% significance level was calculated through a simulation study. For an estimate of the expected treatment effect of the MoOVI-therapy in the power analysis we used the effect size estimate of 1.06 for a graded motor imagery treatment reported by Bowering et al. (2012).

In the simulation study we generated the data patterns of individual cases using a first order autoregressive (AR1) model with a positive autocorrelation of 0.3. The use of this model seemed feasible as it has been shown that this level of autocorrelation is usually present in data from multiple-baseline designs (Shadish & Sullivan, 2011).”

References:

Bowering, K. J., O’Connell, N. E., Tabor, A., Catley, M. J., Leake, H. B., Moseley, G. L., & Stanton, T. R. (2013). The Effects of Graded Motor Imagery and Its Components on Chronic Pain: A Systematic Review and Meta-Analysis. The Journal of Pain, 14(1), 3–13. doi:10.1016/j.jpain.2012.09.007
Bulté, I., & Onghena, P. (2009). Randomization tests for multiple-baseline designs: an extension of the SCRT-R package. Behavior Research Methods, 41(2), 477–485. doi:10.3758/BRM.41.2.477
Shadish, W. R., & Sullivan, K. J. (2011). Characteristics of single-case designs used to assess intervention effects in 2008. Behavior Research Methods, 43(4), 971–980. doi:10.3758/s13428-011-0111-y

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/01/2017
Actual
23/01/2017
Date of last participant enrolment
Anticipated
1/05/2017
Actual
18/09/2017
Date of last data collection
Anticipated
31/07/2017
Actual
17/11/2017
Sample size
Target
12
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 14860 0
4222 - Griffith University

Funding & Sponsors
Funding source category [1] 295156 0
University
Name [1] 295156 0
Griffith University
Country [1] 295156 0
Australia
Primary sponsor type
University
Name
Recover Injury Research Centre, Griffith University
Address
Recover Injury Research Centre
Griffith University
Gold Coast Campus
Parklands Dr
Southport, QLD 4222
Country
Australia
Secondary sponsor category [1] 293979 0
University
Name [1] 293979 0
Sansom Institute for Health Research, University of South Australia
Address [1] 293979 0
North Tce
Adelaide, SA 5000
Country [1] 293979 0
Australia
Secondary sponsor category [2] 294185 0
Charities/Societies/Foundations
Name [2] 294185 0
Physiotherapy Research Foundation
Address [2] 294185 0
Level 1,
1175 Toorak Road,
Camberwell VIC 3124
Country [2] 294185 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296508 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 296508 0
Ethics committee country [1] 296508 0
Date submitted for ethics approval [1] 296508 0
25/03/2016
Approval date [1] 296508 0
27/05/2016
Ethics approval number [1] 296508 0
GU Ref No: 2016/378

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

Contacts
Principal investigator
Name 71098 0
Dr Daniel Simon Harvie
Address 71098 0
Griffith University
Gold Coast Campus
G05_3.20
Parklands Dr,
Southport, QLD 4222
Country 71098 0
Australia
Phone 71098 0
+61418826254
Fax 71098 0
Email 71098 0
[email protected]
Contact person for public queries
Name 71099 0
Daniel Harvie
Address 71099 0
Griffith University
Gold Coast Campus
G05_3.20
Parklands Dr,
Southport, QLD 4222
Country 71099 0
Australia
Phone 71099 0
+61418826254
Fax 71099 0
Email 71099 0
[email protected]
Contact person for scientific queries
Name 71100 0
Daniel Harvie
Address 71100 0
Griffith University
Gold Coast Campus
G05_3.20
Parklands Dr,
Southport, QLD 4222
Country 71100 0
Australia
Phone 71100 0
+61418826254
Fax 71100 0
Email 71100 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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