Clinical trial NCT02979041: VR Training for Pilots With Neck Pain
Official title: Therapeutic Virtual Reality Training for Neck Pain in Israeli Air Force Pilots - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Cervical Pain
Keywords: neck pain
Virtual reality
Range of motion
physiotherapy
Air force
kinematics
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Medical Corps, Israel Defense Force
First posted: 2016-12-01
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity is measured using the Visual Analogue Scale (VAS, 0-100mm)
timeFrame: change from baseline at 4 weeks, 3 and 6 months.
measure: Global perceived effect of the provided treatment is measured on a scale from -5 to +5.
timeFrame: change from baseline at 4 weeks, 3 and 6 months.
measure: Functional outcome is measured by the number of grounding days from flying due to neck pain.
timeFrame: change from baseline at 4 weeks, 3 and 6 months.
Secondary outcomes:
measure: Cervical range of motion is measured using the neck VR system (ROM, degrees)
timeFrame: change from baseline at 4 weeks, 3 and 6 months.
measure: Cervical motion velocity is measured using the neck VR system (degrees/second)
timeFrame: change from baseline at 4 weeks, 3 and 6 months.
measure: Cervical muscles isometric strength is measures using a dynamometer (Newton)
timeFrame: change from baseline at 4 weeks, 3 and 6 months.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: The Faculty of Social Welfare and Health Sciences
city: Tel Hashomer
country: Israel
facility: Medical Aviation Unit
Study officials:
affiliation: Department of Physical Therapy, University of Haifa
name: Hilla Sarig-Bahat, PT, PhD
role: PRINCIPAL_INVESTIGATOR
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