Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000677808
Ethics application status
Approved
Date submitted
20/06/2012
Date registered
25/06/2012
Date last updated
9/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Interactive training methods for the assessment and management of neck pain
Scientific title
Interactive virtual reality training with sensorimotor and kinematic exercises versus sensorimotor and kinematic exercise only, in management of patients with chronic neck pain- Evaluation of the effect on pain, disability, psychological factors, sensorimotor performance and cervical kinematics.
Secondary ID [1] 280704 0
Nil
Universal Trial Number (UTN)
U1111-1131-9736
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic neck pain 286742 0
Condition category
Condition code
Physical Medicine / Rehabilitation 287043 287043 0 0
Physiotherapy
Musculoskeletal 287044 287044 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The two intervention groups will receive different exercise regimes:
Group 1. Sensorimotor and kinematic exercise including balance, repositioning, movement sense and oculomotor (eye movement) exercises. Each participant in group 1 will receive 2x 30 min session per week for 4 weeks. These exercise sessions will be supervised one-on-one by a physiotherapist. In addition participants will be required to complete a daily home exercise program consisting of the exercises taught during the sessions. The participants will be requested to perform their home exercises for 30 minutes, at least 4 times a week. Progression of exercise difficulty level and dossage will be updated every week according to the patient's progress. For example, balance may be challenged with unstable surfaces, single leg stances, number of repetitions and combination of a few tasks may be used in order to increase level of difficulty.

Group 2. Sensorimotor and kinematic exercise plus interactive exercises using the virtual reality system (VR glasses equipped with a tracker). Patients will interact with visual targets in a customised video game displayed in the VR glasses. This game will be controlled by head movement. Each participant in group 2 will receive 2 x 30 minute sessions per week for 4 weeks using the VR device. The VR exercise sessions will be supervised, one-on-one, by a physiotherapist. Patients will also be prescribed and progressed with home sensorimotor and kinematic exercises. Similarly to group 1, the participants in group 2 will be requested to perform their home exercises for 30 minutes, at least 4 times a week. Progression of exercise difficulty level and dossage will be updated every week according to the patient's progress. For example, balance may be challenged with unstable surfaces, single leg stances, number of repeatitions and combination of a few tasks may be used in order to increase level of difficulty.
The difference between the two groups is the use of the VR interactive system which will be included in the intervention of group 2 alone.
Intervention code [1] 285122 0
Rehabilitation
Comparator / control treatment
This study compares two intervention groups. There is no control group.
Control group
Active

Outcomes
Primary outcome [1] 287376 0
Disability as assessed by the Neck Disability Index
Timepoint [1] 287376 0
Baseline, at week 5 from randomization, and at 3 & 6 months follow up.
Primary outcome [2] 287378 0
Cervical range of motion as assessed by the virtual reality system. The VR glasses are equipped with a tracker, including accelometers, gyropscopes and compass based sensors. Head motion data is collected during the assessment and analysed in customised software, resulting range of motion measures. Cervical range of motion will be assessed using the motion tracking sensors of the VR device. This has previously demonstrated reliability and repeatability for this measure.
Timepoint [2] 287378 0
Baseline, at week 5 from randomization, and at 3 & 6 months follow up.
Primary outcome [3] 287379 0
Cervical motion velocity and smoothness as assessed by the virtual reality system. The VR glasses are equipped with a tracker, including accelometers, gyropscopes and compass based sensors. Head motion data is collected during the interactive session using VR. The motion data collected is analysed in a customisedcustomised software and produces a velocity profile including multiple kinematic parameters such as velocity and smoothness of neck motion. Cervical motion, velocity and smoothness will be assessed using the motion tracking sensors of the VR device. This has previously demonstrated reliability and repeatability for this measure.
Timepoint [3] 287379 0
Baseline, at week 5 from randomization, and at 3 & 6 months follow up.
Secondary outcome [1] 298032 0
Pain intensity as assessed by the visual analogue scale
Timepoint [1] 298032 0
Baseline, at week 5 from randomization, and at 3 & 6 months follow up.
Secondary outcome [2] 298033 0
Kinesiophobia as assessed by the TAMPA kinesiophobia scale
Timepoint [2] 298033 0
Baseline, at week 5 from randomization, and at 3 & 6 months follow up.
Secondary outcome [3] 298034 0
Cervical spine joint repositioning:Cervical joint position sense will be measured using the three-space Fastrak system (Polhemus, Navagation Science Division, Kaiser Aerospace Vermont). The Fastrak is a non-invasive electromagnetic device which tracks the positions of sensors in relation to a source in three-dimensions and has also been shown to demonstrate a good reliability and validity. Two sensors: one sensor placed on the forehead via attachment of a light weight headband, the second over the spinous process of C7, will continually record the positions of the head relative to a transmitter source during the entire test sequence. A software program written to format and process the data for three-dimensional analysis of the starting position (zero) and the position to which the head returned will be used. The difference between the starting (zero) and position on return to the starting position will be calculated in degrees for the return from head rotation from the right and left. In this test, the subject is instructed to focus on the natural resting head position for a few seconds, actively rotate the head away, and then try to return to the starting position as accurately as possible while vision is occluded.
Timepoint [3] 298034 0
Baseline, at week 5 from randomization, and at 3 & 6 months follow up.
Secondary outcome [4] 298035 0
Balance will be measured using a computerised, stable force platform (40 X 60 centimetres) The ground reaction forces are registered by force transducers located in each corner of the plate to measure force changes over time in both the ML and AP directions. The signals will be recorded on a computer and the raw traces produced both numerically and graphically (Kistler 9286AA, North America). A total of 4, 30-second tests will be performed. These will include standing in comfortable stance with eyes open and eyes closed and then repeated while the subject is standing on a 10cm high-density piece of foam placed on the platform. In all tests, subjects will be asked to stand as steadily and quietly as possible with their arms by their sides for 30 seconds. A custom made Matlab program will calculate the total energy and RMS for each test.
Timepoint [4] 298035 0
Baseline, at week 5 from randomization, and at 3 & 6 months follow up.
Secondary outcome [5] 298036 0
Patient satisfaction will be measured using a 10 point likert scale for 2 questions. 1. The amount of change on their neck pain/ symptoms since the treatment and 2. The overall satisfaction with the treatment.
Timepoint [5] 298036 0
At week 5 from randomization, and at 3 & 6 months follow up

Eligibility
Key inclusion criteria
1. Age: 18 years or more
2. Neck pain for more than 6 weeks
3. Mild to severe symptom severity, greater than 10% in the VAS and NDI.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Evidence for active vestibular complaints such as acute dizziness, imbalance, nystagmus, diplopia.
2. Medical conditions that may affect the cervical spine including Rheumatic disorders, Arthritis stage 3-4, Diabetes Mellitus, neurological disorders, traumatic head injuries, lower limb pathologies that restrict sitting, or any painful condition other than neck pain, at the time of the assessment.
3. Inability to communicate and provide informed consent. .
4. Inability to participate in exercise / rehabilitation program.
5. Unstable fracture / dislocation.
6. Post orthopedic surgery in the upper body or spine.
7. Female participants who are pregnant.
8. Any reason repeated movements of the neck would be contra-indicated.

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)
delete the sentence "by pulling a note out of a box."
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will initially be stratified according to whether or not they have at least one deficit in sensorimotor values (greater than 2 sd of the mean value for control subjects for either joint position sense or balance). Subjects will either be labeled sensorimotor + or –ve. Block randomisation using a randomisation table generated by a computerised sequence will then be used for each subject according to the stratified group they are allocated to.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2012
Actual
4/07/2012
Date of last participant enrolment
Anticipated
Actual
10/08/2012
Date of last data collection
Anticipated
Actual
31/01/2013
Sample size
Target
60
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 285473 0
University
Name [1] 285473 0
University of Haifa
Country [1] 285473 0
Israel
Primary sponsor type
University
Name
University of Queensland
Address
CCRE Spine SHRS
University OF Queensland
St Lucia
QLD
4067
Australia
Country
Australia
Secondary sponsor category [1] 284326 0
None
Name [1] 284326 0
Address [1] 284326 0
Country [1] 284326 0
Other collaborator category [1] 276869 0
University
Name [1] 276869 0
University of Haifa, Department of Physical Therapy
Address [1] 276869 0
Department of Physical Therapy
University of Haifa
Mt. Carmel
Haifa 31905
ISRAEL
Country [1] 276869 0
Israel

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287487 0
Human Ethics, Research Management Office, UQ Research and Innovation
Ethics committee address [1] 287487 0
Ethics committee country [1] 287487 0
Australia
Date submitted for ethics approval [1] 287487 0
24/05/2012
Approval date [1] 287487 0
12/06/2012
Ethics approval number [1] 287487 0
AMENDMENT (#H246)

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

Contacts
Principal investigator
Name 34339 0
Dr Julia TReleaven
Address 34339 0
CCRE Spine SHRS University OF Queensland St Lucia QLD 4067 Australia
Country 34339 0
Australia
Phone 34339 0
W: +61 07 33654568, Mob: +61 04 11773790
Fax 34339 0
Email 34339 0
[email protected]
Contact person for public queries
Name 17586 0
Dr. Julia Treleaven
Address 17586 0
CCRE Spine SHRS
University OF Queensland
St Lucia
QLD 4067
Australia
Country 17586 0
Australia
Phone 17586 0
W: +61 07 33654568, Mob: +61 04 11773790
Fax 17586 0
+61 07 33651877
Email 17586 0
[email protected]
Contact person for scientific queries
Name 8514 0
Dr. Julia Treleaven
Address 8514 0
CCRE Spine SHRS
University OF Queensland
St Lucia
QLD 4067
Australia
Country 8514 0
Australia
Phone 8514 0
W: +61 07 33654568, Mob: +61 04 11773790
Fax 8514 0
+61 07 33651877
Email 8514 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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