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Trial registered on ANZCTR


Registration number
ACTRN12615000231549
Ethics application status
Approved
Date submitted
12/02/2015
Date registered
13/03/2015
Date last updated
23/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Interactive home training for the management of chronic neck pain.
Scientific title
Remote kinematic e-training/healthcare for patients with chronic neck pain, a randomised controlled trial evaluating the effectiveness of interactive training using laser feedback versus virtual reality interaction on global perceived effect, neck disability, and cervical kinematics.
Secondary ID [1] 286137 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic neck pain 294144 0
Condition category
Condition code
Musculoskeletal 294464 294464 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 294465 294465 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible participants will be randomised into either control, laser kinematic training (LKT) or virtual reality kinematic training (VRKT). The baseline assessment will also provide the initial values for training in regards to ROM and kinematics in the VRKT group. ROM results will determine the positioning of interactive VR targets during training for the VRKT group.
The patients in both intervention groups- LKT, and VRKT, will be taught how to train by a qualified physiotherapist during a 60 minutes session at baseline. Patients in the LKT group will be provided with training equipment including head-laser beam and poster for home use. Patietns in the VRKT group will be provided with the hardware and software for this purpose. Patients in LKT and VRKT groups will be instructed to train in short trainings of up to 5 minutes continuously to avoid side effects. Training dosage will be 5 minutes 4 times a day, i.e. 20 minutes a day, 5 times a week.
After 2 weeks of training they will have another session with the physiotherapist to progress their training difficulty level, help solving problems and reasure they are consistent with traiing. The overall duration of training in the VRKT and LKT will be 4 weeks.
Each participant in the intervention group will be provided with a training plan directed towards:
a. Increasing ROM
b. Increasing motion velocity
c. Increasing motion accuracy in smooth head pursuit
Or a combination of the above. Training positions will be modified, from sitting to standing, single leg stand, or standing on a dynamic surface to assist progression of difficulty of the exercises.
All participants will be required to complete an exercise diary.
Intervention code [1] 291137 0
Rehabilitation
Intervention code [2] 291252 0
Treatment: Devices
Comparator / control treatment
The control group will recieve no treatment during the waiting period of 4 weeks, while the intervention groups recieve training. Following their waiting period they will then be randomised to receive one of the two treatments.
Control group
Active

Outcomes
Primary outcome [1] 294248 0
Global perceived effect (GPE) will be rated using an 11-point scale (-5 vastly worse, 0= no change, 5 completely recovered). The GPE appears to capture change in different domains important to the individual (Evans et al. , 2014)
Timepoint [1] 294248 0
Immediately post 4 week-intervention, 3 months post intervention.
Primary outcome [2] 294249 0
NDI: (Vernon and Mior, 1991) was used to examine self-reported disability associated with neck pain. Higher percentage scores indicate greater disability. The NDI has been shown to demonstrate good validity and reliability 1 (Cleland et al. , 2006, Hoving et al. , 2003, Pietrobon et al., 2002). A minimal clinical important change (MCIC) of 7% is thought to be realistic (Pool et al., 2007).
Timepoint [2] 294249 0
Baseline and or immediatley pre intervention, immediately post intervention, 3 months post-intervention
Primary outcome [3] 294250 0
Cervical motion velocity will be collected using a customised VR system with new hardware and software to execute the same rationale of the first VR system previously studied (Sarig-Bahat, Weiss, 2010). Peak and mean velocity (Vpeak, Vmean degrees/sec) will be collected from 16 trials, four from each direction (flexion, extension, right and left rotation). The overall Vpeak and Vmean result will be calculated as the mean of three maximal results achieved.
Timepoint [3] 294250 0
Baseline and or immediately pre intervention, immediately post intervention, 3 months post-intervention
Secondary outcome [1] 312874 0
Self-reported neck pain intensity (VAS)- average pain intensity during recent week, and pain on movement at the time of the assessment.
Timepoint [1] 312874 0
Baseline and or immediately pre intervention, immediately post intervention, 3 months post-intervention
Secondary outcome [2] 312876 0
Self-reported quality of life (European quality of life questionnaire- EuroQ5D)
Timepoint [2] 312876 0
Baseline and or immediately pre intervention, immediately post intervention, 3 months post-intervention
Secondary outcome [3] 312877 0
Fear of motion, as measured by the TAMPA Scale of Kinesiophobia
Timepoint [3] 312877 0
Baseline and or immediately pre intervention, immediately post intervention, 3 months post-intervention
Secondary outcome [4] 312878 0
Active cervical range of motion will be assessed for flexion, extension, right rotation and left rotation, as measured by the VR system.
Timepoint [4] 312878 0
Baseline and or immediately pre intervention, immediately post intervention, 3 months post-intervention
Secondary outcome [5] 313133 0
Cervical motion smoothness will be represented by the number of velocity peaks (NVP), analysed for each trial in the velocity module, as measured by the VR system. This value will be calculated for flexion, extension, right and left rotation of the neck.
Timepoint [5] 313133 0
Baseline and/or immediately pre-intervention; immediately post-intervention, 3 months post-intervention.
Secondary outcome [6] 313134 0
Cervical motion symmetry will be represented by the value of time to peak velocity percentage, out of the total movement time, as measured by the VR system.
Timepoint [6] 313134 0
Baseline and/or immediately pre-intervention; immediately post-intervention, 3 months post-intervention.
Secondary outcome [7] 313135 0
Cervical motion accuracy will be measured during the VR accuracy module. This value will consist of the difference between the target position and the player's position in each movement plane.
Timepoint [7] 313135 0
Baseline and/or immediately pre-intervention; immediately post-intervention, 3 months post-intervention.

Eligibility
Key inclusion criteria
Inclusion criteria: 1) age 18 years or more; 2) prolonged neck pain for more than three months; and 3) Neck Disability Index (NDI) score greater than 12%. VAS (average during recent week) >10 mm.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: existing vestibular pathology; cervical fracture/dislocation; systemic diseases such as neurological, cardiovascular, or respiratory disorders affecting physical performance; history of traumatic head injury; inability to provide informed consent; or pregnancy.
Patients will be excluded if results of their VR kinematic assessment reach normative values on at least 3/6 measures, from Vpeak and Vmean in right & left rotations and extension.

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)
Procedure
Participants will be screened via telephone or email for initial inclusion/ exclusion criteria. Following informed consent, potential participants will then be required to undertake a baseline kinematic assessment to further determine eligibility.
Eligible participants will be randomised into either control or intervention groups. Those undergoing the intervention will then be randomised into either LKT or VRKT in a concealed allocation procedure using central randomisation by computer. Assessors will be blinded to the groups allocation at all time points.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible patients will be randomization in 2 phases: first, recruited patients will be randomised into control, LKT or VRKT. Following the 4-weeks waiting period the control group will be further randomised into either kinematic training using the laser (LKT) or kinematic training using the VR device (VRKT).
The computed randomisation system will be designed to initially form 30 individuals in each group, with a total N=90 (30 control, 30 LKT, 30 VRKT) to first compare between the 3 groups pre-post intervention. At the end of the trial, there will be 45 patients who trained in the LKT and another 45 who trained in the VRKT group (30+15 from the control group). This will allow inter- training groups comparison post intervention, with a total n=90.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical analysis
Data will be explored for normality and if found to be normally distributed parametric analysis will be performed. Between and within group differences will be evaluated for the change between pre- and post-intervention results using an ANOVA analysis. The comparisons will analyse differences between: a) control to each training group; b) intervention VRKT to intervention LKT; pre to post intervention within group. Sample size was calculated using a power of 9 with a significance level of 0.05, with effect size of 0.07 and using 2 tailed statistical analysis. Cohen’s ‘d’ will be used to determine the effect size of each measure. Intention-to-treat analysis will be used to manage drop outs in this proposed study. Significance levels will be set at 5%.
The study's hypothesis are that there will be a significant difference in the pre-to post- intervention change, between the control and the intervention groups (p<0.05). A secondary hypothesis is that the VRT may result a larger change than the LKT (p<0.05)
All significant differences will be evaluated by their Cohen's d value: absolute d between 0.5 and 0.8 will demonstrated a medium effect size, and an absolute d=0.8, a large effect size(Cohen, 1988). We hypothesis that medium to large effect size changes will be demostrated in global perceived effect, and in cervical motion velocity.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 9204 0
4067 - St Lucia

Funding & Sponsors
Funding source category [1] 290712 0
Government body
Name [1] 290712 0
Queensland Health, Health and Medical Research,
Preventive Health Unit.
Physiotherapy Research Fellowships (HMR)
Address [1] 290712 0
Queensland Health Building
147-163 Charlotte Street
Brisbane Queensland 4000 Australia
Country [1] 290712 0
Australia
Primary sponsor type
Individual
Name
Dr Julia Treleaven
Address
CCRE Spine, Division of Physiotherapy,
School of Health and Rehabilitation Sciences
The University of Queensland QLD 4072 Australia
Country
Australia
Secondary sponsor category [1] 289411 0
None
Name [1] 289411 0
Address [1] 289411 0
Country [1] 289411 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292343 0
Human Ethics Comittee, University of Queensland
Ethics committee address [1] 292343 0
St Lucia
QLD 4067
Australia
Ethics committee country [1] 292343 0
Australia
Date submitted for ethics approval [1] 292343 0
Approval date [1] 292343 0
07/05/2014
Ethics approval number [1] 292343 0
2014000421

Summary
Brief summary
Neck pain is a common health disorder in adults.
This research aims to evaluate the efficacy of home based training in patients with chronic neck pain. Home training will include exercises designed to advance coordination and control of the neck. A secondary aim will be to evaluate the differences between training with a laser beam feedback, to a virtual reality gaming scenario. It is hypothesised that both types of training will advance patients’ performance, and possibly the VR may have some advantages. Ultimately this methodology could have important implications for future use in remote e-health.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54786 0
Dr Julia Treleaven
Address 54786 0
CCRE Spine SHRS University of Queensland
St. Lucia
Qld 4067
Country 54786 0
Australia
Phone 54786 0
+61411773790
Fax 54786 0
Email 54786 0
j.treleaven@uq.edu.au
Contact person for public queries
Name 54787 0
Dr Julia Treleaven
Address 54787 0
CCRE Spine SHRS University of Queensland
St. Lucia
Qld 4067
Country 54787 0
Australia
Phone 54787 0
+61411773790
Fax 54787 0
Email 54787 0
j.treleaven@uq.edu.au
Contact person for scientific queries
Name 54788 0
Dr Hilla Sarig Bahat
Address 54788 0
University of Haifa
Faculty of Social Welfare and Health Sciences
The Department of Physical Therapy
199 Aba Khoushy Ave.
Mount Carmel, Haifa
Israel 3498838
Country 54788 0
Israel
Phone 54788 0
+972,054,545380483
Fax 54788 0
Email 54788 0
hbahat@research.haifa.ac.il

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary