VR Training for Pilots With Neck Pain

Study Overview
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Brief Summary
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The aim of the proposed study is to investigate the effectiveness of an interactive, virtual reality (VR) training program for pilots compared with standard care. The study will be a randomized controlled trial (RCT) consisting of 60 pilots randomized into one of two groups: standard physiotherapy and medical care vs standard care and VR training. Outcome measures will include subjective scores of pain intensity and global perceived effect; objective measures of range of motion (ROM), neck motion velocity, and motion accuracy; and functional measure of days grounded due to neck pain. Data will be analyzed using ANOVA for within and between groups analyses.

Detailed Description
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The aim of the proposed study is to investigate the effectiveness of an interactive, virtual reality (VR) training program for pilots compared with standard care. The proposed intervention program includes training in neck range of motion, control, accuracy and coordination and is expected to reduce the prevalence and operational impact of neck pain in the intervention group more effectively than does standard care alone. The proposed study will be designed as a randomized, controlled trial (RCT). Sixty fighter and helicopter pilots will be randomized into two groups, to receive either standard physiotherapy and medical care or standard care with the addition of interactive, dynamic, controlled training (a self-exercise program) in VR to address the fast, accurate head control required in flying tasks. Subjective outcome measures will include pain intensity and global perceived effect. Objective measures will include range of motion, motion velocity and accuracy. The functional measure will include days grounded due to neck pain. Statistical analysis will use independent, repeated measures ANOVA on each parameter, within and between groups. Post hoc comparisons, including several preplanned contrasts, will be performed to assess differences before and after treatment, and the stability of changes over time, in each group. The relationship of risk factors to performance failures will be assessed using multivariate logistic regression analyses. This study is the first in the Israeli Air Force to evaluate this type of comprehensive, functional intervention program. Such research will dramatically advance the military's health care approach to neck pain, and may be further applied to other populations in and outside the Israeli Defence Force (IDF). This study may serve as a stepping stone to further research related to diagnosis, treatment, and prevention methods during a pilot's active service.

Official Title
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Therapeutic Virtual Reality Training for Neck Pain in Israeli Air Force Pilots - A Randomized Controlled Trial

Conditions
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Neck Pain, Cervical Pain

Intervention / Treatment
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* Behavioral: Interactive virtual reality training
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fighter and helicopter pilots from the Israeli Air Force acute, sub-acute, and chronic neck pain, with or without referral to the upper limbs Exclusion Criteria: neurological disorders (e.g. evidence for positive neurological signs), systemic disease, history of spinal surgery, or any disorders that may limit the ability to exercise

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>Patients in the control group will receive standard physiotherapy and medical care, as provided to all patients with neck pain in the aviation medicine clinic. This will reflect the standard care that has been provided to all patients. | Other: Standard Care<br>* physiotherapy and medical care as provided currently<br>|
| Experimental: intervention<br>Standard care (as provided to controls) with the addition of virtual reality training (a self-exercise program) using a VR system to address the fast, accurate head control required in flying tasks. | Behavioral: Interactive virtual reality training<br>* The proposed VR intervention program will provide active training to be performed individually 4 times a week for 20 minutes a session. The intervention program will be supervised by qualified, experienced physiotherapists, and will include individual training and two follow up meetings during the study period. The intervention program will include strengthening and endurance exercises for the cervical and shoulder girdle muscles. Training will include sensorimotor control and functional, quick, accurate, neck motion, using interactive VR training systems. This type of advanced training is very relevant to the pilots function in the cockpit as it includes interactive tasks aimed to increase range, speed, smoothness, accuracy, and control of cervical motion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity is measured using the Visual Analogue Scale (VAS, 0-100mm) | Pain intensity was measured using the Visual Analogue Scale (VAS, 0-100mm) | change from baseline at 4 weeks, 3 and 6 months. | 
| Global perceived effect of the provided treatment is measured on a scale from -5 to +5. | Global perceived effect of the provided treatment was measured on a scale from -5 to +5. Zero represented no change, +5 excellent improvement due to the treatment provided, and -5, vast worsening. | change from baseline at 4 weeks, 3 and 6 months. | 
| Functional outcome is measured by the number of grounding days from flying due to neck pain. | The number of days the pilot was grounded due to neck pain. | change from baseline at 4 weeks, 3 and 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical range of motion is measured using the neck VR system (ROM, degrees) | Cervical range of motion (ROM, degrees) is measured using the neck VR system, into flexion, extension, right and left rotation. | change from baseline at 4 weeks, 3 and 6 months. | 
| Cervical motion velocity is measured using the neck VR system (degrees/second) | Cervical motion velocity is measured using the neck VR system (degrees/second) into flexion, extension, right and left rotation. | change from baseline at 4 weeks, 3 and 6 months. | 
| Cervical muscles isometric strength is measures using a dynamometer (Newton) | Cervical muscles isometric strength is measures using a dynamometer (Newton), in the directions of static flexion and extension. | change from baseline at 4 weeks, 3 and 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neck pain, Virtual reality, Range of motion, physiotherapy, Air force, kinematics