VR Training for Pilots With Neck Pain

• ClinicalTrials.gov Identifier: NCT02979041
• Recruitment Status: Completed
• First Posted: December 1, 2016
• Last Update Posted: May 24, 2018
• Sponsor: University of Haifa
• Collaborator: Medical Corps, Israel Defense Force
• Information provided by (Responsible Party): University of Haifa

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Neck Pain; Cervical Pain	Behavioral: Interactive virtual reality training; Other: Standard Care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Therapeutic Virtual Reality Training for Neck Pain in Israeli Air Force Pilots - A Randomized Controlled Trial
• Study Start Date: September 1, 2016
• Actual Primary Completion Date: December 30, 2017
• Actual Study Completion Date: December 30, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: control; 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; physiotherapy and medical care as provided currently
Experimental: intervention; 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; 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Israel

The Faculty of Social Welfare and Health Sciences

Haifa, Israel, 3498838

Medical Aviation Unit

Tel Hashomer, Israel

Sponsors and Collaborators

University of Haifa

Medical Corps, Israel Defense Force

Investigators

• Principal Investigator: Hilla Sarig-Bahat, PT, PhD; Department of Physical Therapy, University of Haifa

More Information

Publications:

van den Oord MH, De Loose V, Meeuwsen T, Sluiter JK, Frings-Dresen MH. Neck pain in military helicopter pilots: prevalence and associated factors. Mil Med. 2010 Jan;175(1):55-60. doi: 10.7205/milmed-d-09-00038.

Tucker B, Netto K, Hampson G, Oppermann B, Aisbett B. Predicting neck pain in Royal Australian Air Force fighter pilots. Mil Med. 2012 Apr;177(4):444-50. doi: 10.7205/milmed-d-11-00256.

Grossman A, Nakdimon I, Chapnik L, Levy Y. Back symptoms in aviators flying different aircraft. Aviat Space Environ Med. 2012 Jul;83(7):702-5. doi: 10.3357/asem.3225.2012.

Knudson R, McMillan D, Doucette D, Seidel M. A comparative study of G-induced neck injury in pilots of the F/A-18, A-7, and A-4. Aviat Space Environ Med. 1988 Aug;59(8):758-60.

Sarig Bahat H, Weiss PL, Laufer Y. The effect of neck pain on cervical kinematics, as assessed in a virtual environment. Arch Phys Med Rehabil. 2010 Dec;91(12):1884-90. doi: 10.1016/j.apmr.2010.09.007.

Jones JA, Hart SF, Baskin DS, Effenhauser R, Johnson SL, Novas MA, Jennings R, Davis J. Human and behavioral factors contributing to spine-based neurological cockpit injuries in pilots of high-performance aircraft: recommendations for management and prevention. Mil Med. 2000 Jan;165(1):6-12.

Ang BO, Monnier A, Harms-Ringdahl K. Neck/shoulder exercise for neck pain in air force helicopter pilots: a randomized controlled trial. Spine (Phila Pa 1976). 2009 Jul 15;34(16):E544-51. doi: 10.1097/BRS.0b013e3181aa6870.

Alricsson M, Harms-Ringdahl K, Larsson B, Linder J, Werner S. Neck muscle strength and endurance in fighter pilots: effects of a supervised training program. Aviat Space Environ Med. 2004 Jan;75(1):23-8.

Hamalainen O, Heinijoki H, Vanharanta H. Neck training and +Gz-related neck pain: a preliminary study. Mil Med. 1998 Oct;163(10):707-8.

Sarig Bahat H, Takasaki H, Chen X, Bet-Or Y, Treleaven J. Cervical kinematic training with and without interactive VR training for chronic neck pain - a randomized clinical trial. Man Ther. 2015 Feb;20(1):68-78. doi: 10.1016/j.math.2014.06.008. Epub 2014 Jul 5.

• Responsible Party: University of Haifa
• ClinicalTrials.gov Identifier: NCT02979041
• Other Study ID Numbers: UHaifaAF
• First Posted: December 1, 2016
• Last Update Posted: May 24, 2018
• Last Verified: June 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by University of Haifa:

neck pain; Virtual reality; Range of motion; physiotherapy; Air force; kinematics

Additional relevant MeSH terms:

Neck Pain; Pain; Neurologic Manifestations