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VR Training for Pilots With Neck Pain

Primary Purpose

Neck Pain, Cervical Pain

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Interactive virtual reality training
Standard Care
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, Virtual reality, Range of motion, physiotherapy, Air force, kinematics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Faculty of Social Welfare and Health Sciences
  • Medical Aviation Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control

intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain intensity is measured using the Visual Analogue Scale (VAS, 0-100mm)
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.
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.
The number of days the pilot was grounded due to neck pain.

Secondary Outcome Measures

Cervical range of motion is measured using the neck VR system (ROM, degrees)
Cervical range of motion (ROM, degrees) is measured using the neck VR system, into flexion, extension, right and left rotation.
Cervical motion velocity is measured using the neck VR system (degrees/second)
Cervical motion velocity is measured using the neck VR system (degrees/second) into flexion, extension, right and left rotation.
Cervical muscles isometric strength is measures using a dynamometer (Newton)
Cervical muscles isometric strength is measures using a dynamometer (Newton), in the directions of static flexion and extension.

Full Information

First Posted
October 5, 2016
Last Updated
May 23, 2018
Sponsor
University of Haifa
Collaborators
Medical Corps, Israel Defense Force
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1. Study Identification

Unique Protocol Identification Number
NCT02979041
Brief Title
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

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (undefined)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Haifa
Collaborators
Medical Corps, Israel Defense Force

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Cervical Pain
Keywords
neck pain, Virtual reality, Range of motion, physiotherapy, Air force, kinematics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interactive virtual reality training
Intervention Description
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 Type
Other
Intervention Name(s)
Standard Care
Intervention Description
physiotherapy and medical care as provided currently
Primary Outcome Measure Information:
Title
Pain intensity is measured using the Visual Analogue Scale (VAS, 0-100mm)
Description
Pain intensity was measured using the Visual Analogue Scale (VAS, 0-100mm)
Time Frame
change from baseline at 4 weeks, 3 and 6 months.
Title
Global perceived effect of the provided treatment is measured on a scale from -5 to +5.
Description
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.
Time Frame
change from baseline at 4 weeks, 3 and 6 months.
Title
Functional outcome is measured by the number of grounding days from flying due to neck pain.
Description
The number of days the pilot was grounded due to neck pain.
Time Frame
change from baseline at 4 weeks, 3 and 6 months.
Secondary Outcome Measure Information:
Title
Cervical range of motion is measured using the neck VR system (ROM, degrees)
Description
Cervical range of motion (ROM, degrees) is measured using the neck VR system, into flexion, extension, right and left rotation.
Time Frame
change from baseline at 4 weeks, 3 and 6 months.
Title
Cervical motion velocity is measured using the neck VR system (degrees/second)
Description
Cervical motion velocity is measured using the neck VR system (degrees/second) into flexion, extension, right and left rotation.
Time Frame
change from baseline at 4 weeks, 3 and 6 months.
Title
Cervical muscles isometric strength is measures using a dynamometer (Newton)
Description
Cervical muscles isometric strength is measures using a dynamometer (Newton), in the directions of static flexion and extension.
Time Frame
change from baseline at 4 weeks, 3 and 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilla Sarig-Bahat, PT, PhD
Organizational Affiliation
Department of Physical Therapy, University of Haifa
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Faculty of Social Welfare and Health Sciences
City
Haifa
ZIP/Postal Code
3498838
Country
Israel
Facility Name
Medical Aviation Unit
City
Tel Hashomer
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20108843
Citation
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.
Results Reference
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PubMed Identifier
22594136
Citation
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.
Results Reference
background
PubMed Identifier
22779315
Citation
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.
Results Reference
background
PubMed Identifier
3178626
Citation
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.
Results Reference
background
PubMed Identifier
21112430
Citation
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.
Results Reference
background
PubMed Identifier
10658420
Citation
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.
Results Reference
background
PubMed Identifier
19770596
Citation
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.
Results Reference
background
PubMed Identifier
14736129
Citation
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.
Results Reference
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PubMed Identifier
9795549
Citation
Hamalainen O, Heinijoki H, Vanharanta H. Neck training and +Gz-related neck pain: a preliminary study. Mil Med. 1998 Oct;163(10):707-8.
Results Reference
background
PubMed Identifier
25066503
Citation
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.
Results Reference
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VR Training for Pilots With Neck Pain

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