VR Training for Pilots With Neck Pain

Not Applicable

Completed

• Conditions: Neck Pain; Cervical Pain
• Interventions: Other: Standard Care; Behavioral: Interactive virtual reality training

• Registration Number: NCT02979041
• Lead Sponsor: University of Haifa

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.

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-09-01
• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-12-01
• Primary Completion: 2017-12-30
• Study Completion: 2017-12-30
• Last Update Submitted: 2018-05-23
• Last Update Posted: 2018-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Standard Care	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.
intervention	Interactive virtual reality training	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.

Primary Outcome Measures

Name	Time	Method
Pain intensity is measured using the Visual Analogue Scale (VAS, 0-100mm)	change from baseline at 4 weeks, 3 and 6 months.	Pain intensity was measured using the Visual Analogue Scale (VAS, 0-100mm)
Global perceived effect of the provided treatment is measured on a scale from -5 to +5.	change from baseline at 4 weeks, 3 and 6 months.	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.
Functional outcome is measured by the number of grounding days from flying due to neck pain.	change from baseline at 4 weeks, 3 and 6 months.	The number of days the pilot was grounded due to neck pain.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Medical Aviation Unit; 🇮🇱 Tel Hashomer, Israel

The Faculty of Social Welfare and Health Sciences; 🇮🇱 Haifa, Israel