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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]

Nil

Universal Trial Number (UTN)

U1111-1190-8259

Trial acronym

Linked study record

Health condition

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

Neck pain

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

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]

Rehabilitation

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

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]

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]

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]

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]

Neck Disability Index

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4222 - Griffith University

Funding & Sponsors

Funding source category [1]

University

Name [1]

Griffith University

Address [1]

Griffith University
Gold Coast Campus
Parklands Dr, QLD
Southport 4222

Country [1]

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]

University

Name [1]

Sansom Institute for Health Research, University of South Australia

Address [1]

North Tce
Adelaide, SA 5000

Country [1]

Australia

Secondary sponsor category [2]

Charities/Societies/Foundations

Name [2]

Physiotherapy Research Foundation

Address [2]

Level 1,
1175 Toorak Road,
Camberwell VIC 3124

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Griffith University Human Research Ethics Committee

Ethics committee address [1]

Nathan campus
Room 0.10D, The Bray Centre (N54)
Griffith University
170 Kessels Road, Nathan QLD 4111

Ethics committee country [1]

Date submitted for ethics approval [1]

25/03/2016

Approval date [1]

27/05/2016

Ethics approval number [1]

GU Ref No: 2016/378

Summary

Brief summary

Illusory movement as therapy: Background and plausible mechanisms.

To date, persistent pain treatments targeting suspected tissue pathology have shown to have very limited or no ongoing benefit (see e.g. van Tulder et al., 2006a; van Tulder et al., 2006b).  The quest for better treatments has seen attention shifted to include central mechanisms (Wand et al. 2011; Moseley & Flor 2012). While cognitive and behavioural approaches targeting thoughts, beliefs and behaviors undoubtedly have potential to alter neural processes associated with pain, considering brain-based approaches from a perceptual and brain science perspective will likely lead to a range of different treatment avenues. Recent perspectives highlight several pathways by which perception-altering associative learning processes might lead to chronic pain (Moseley & Vlaeyen 2015; Tabor et al. in publication; Zaman et al. 2015). Further, recent reviews have highlighted a potential role for multisensory illusions in developing future treatment opportunities (Senkowski and Heinz 2016; Moseley & Flor 2014; Boesch et al. 2016). It follows that similar mechanisms applied differently might reverse some of these processes.

The view of chronic pain employed here, is one where pain persists because the affected body part(s) in someway continue to be represented in the brain as being under threat and requiring certain protections—perhaps because the injurious event-related encoding persists (Moseley & Vlaeyen 2015). One way to consider altering this bodily threat-related neural encoding is to disconfirm implicit expectations of pain, such as those during associated with movements. This requires an experience that is normally painful to be experienced without pain. Such violations of expectation are known to be powerful drivers of learning (Rescorla & Wagner, 1972), and are thought to alter prior implicit expectancies that may drive the resulting pain responses (Tabor et al. in press). 

Under normal clinical conditions, creating pain-free or non-threatening movement experiences, through which to extinguish implicit expectations of pain, can be difficult. The MoOVi illusion presents an opportunity for users to experience ranges of pain-free movement that exceed the expected range of pain-free movement. Doing so may assist to reinstate a less threatened bodily representation. This is conceptually similar, not only to mirror therapy, but to Graded Motor Imagery (GMI) — which targets progressive activation of motor processes without triggering unwanted protective responses (Moseley 2004; Moseley 2006). Indeed the final phase of three in graded motor imagery is illusory movement with mirror therapy, which has preliminary evidence of benefit for arm pain (Bowering et al. 2013).

The purpose of this study is to determine whether pain-free illusory movement can reduce pain. We hypothesise that illusory movement exercises will reduce pain greater than movement alone.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Daniel Simon Harvie

Address

Griffith University
Gold Coast Campus
G05_3.20
Parklands Dr,
Southport, QLD 4222

Country

Australia

Phone

+61418826254

Fax

d.harvie@griffith.edu.au

Contact person for public queries

Name

Daniel Harvie

Address

Griffith University
Gold Coast Campus
G05_3.20
Parklands Dr,
Southport, QLD 4222

Country

Australia

Phone

+61418826254

Fax

d.harvie@griffith.edu.au

Contact person for scientific queries

Name

Daniel Harvie

Address

Griffith University
Gold Coast Campus
G05_3.20
Parklands Dr,
Southport, QLD 4222

Country

Australia

Phone

+61418826254

Fax

d.harvie@griffith.edu.au

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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