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Completed

NCT Number: NCT02979041

VR Training for Pilots With Neck Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Faculty of Social Welfare and Health Sciences, Haifa, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interactive virtual reality training

Behavioral

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.

Standard care

Other

physiotherapy and medical care as provided currently

Primary outcomes

  1. Pain intensity is measured using the Visual Analogue Scale (VAS, 0-100mm)

    Time frame: change from baseline at 4 weeks, 3 and 6 months.

    Pain intensity was measured using the Visual Analogue Scale (VAS, 0-100mm)

  2. Global perceived effect of the provided treatment is measured on a scale from -5 to +5.

    Time frame: 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.

  3. Functional outcome is measured by the number of grounding days from flying due to neck pain.

    Time frame: change from baseline at 4 weeks, 3 and 6 months.

    The number of days the pilot was grounded due to neck pain.

Secondary outcomes

  1. Cervical range of motion is measured using the neck VR system (ROM, degrees)

    Time frame: 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.

  2. Cervical motion velocity is measured using the neck VR system (degrees/second)

    Time frame: 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.

  3. Cervical muscles isometric strength is measures using a dynamometer (Newton)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Collaborators

  • Medical Corps, Israel Defense Force

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 1, 2016
Registry last updated
May 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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