VR Training for Pilots With Neck Pain

NCT02979041 | Completed

• 1 other identifier: UHaifaAF
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

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.

Conditions

Neck Pain; Cervical Pain

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

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

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

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

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

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

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

Study Arms (2)

control

ACTIVE COMPARATOR

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

intervention

EXPERIMENTAL

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

Interventions

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.

intervention

Standard Care OTHER

physiotherapy and medical care as provided currently

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• fighter and helicopter pilots from the Israeli Air Force
• acute, sub-acute, and chronic neck pain, with or without referral to the upper limbs

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Haifa: lead
• Medical Corps, Israel Defense Force: collaborator

Study Sites (2)

The Faculty of Social Welfare and Health Sciences

Haifa, 3498838, Israel

Location

Medical Aviation Unit

Tel Litwinsky, Israel

Location

Related Publications (10)

• 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.

  PMID: 20108843 BACKGROUND

• 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.

  PMID: 22594136 BACKGROUND

• 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.

  PMID: 22779315 BACKGROUND

• 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.

  PMID: 3178626 BACKGROUND

• 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.

  PMID: 21112430 BACKGROUND

• 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.

  PMID: 10658420 BACKGROUND

• 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.

  PMID: 19770596 BACKGROUND

• 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.

  PMID: 14736129 BACKGROUND

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

  PMID: 9795549 BACKGROUND

• 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.

  PMID: 25066503 BACKGROUND

MeSH Terms

Conditions

Neck Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Hilla Sarig-Bahat, PT, PhD

  Department of Physical Therapy, University of Haifa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: December 1, 2016
• Study Start: September 1, 2016
• Primary Completion: December 30, 2017
• Study Completion: December 30, 2017
• Last Updated: May 24, 2018

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)