<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02979041</url>
  </required_header>
  <id_info>
    <org_study_id>UHaifaAF</org_study_id>
    <nct_id>NCT02979041</nct_id>
  </id_info>
  <brief_title>VR Training for Pilots With Neck Pain</brief_title>
  <official_title>Therapeutic Virtual Reality Training for Neck Pain in Israeli Air Force Pilots - A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Haifa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Corps, Israel Defense Force</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Haifa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the proposed study is to investigate the effectiveness of an interactive, virtual&#xD;
      reality (VR) training program for pilots compared with standard care. The study will be a&#xD;
      randomized controlled trial (RCT) consisting of 60 pilots randomized into one of two groups:&#xD;
      standard physiotherapy and medical care vs standard care and VR training. Outcome measures&#xD;
      will include subjective scores of pain intensity and global perceived effect; objective&#xD;
      measures of range of motion (ROM), neck motion velocity, and motion accuracy; and functional&#xD;
      measure of days grounded due to neck pain. Data will be analyzed using ANOVA for within and&#xD;
      between groups analyses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the proposed study is to investigate the effectiveness of an interactive, virtual&#xD;
      reality (VR) training program for pilots compared with standard care. The proposed&#xD;
      intervention program includes training in neck range of motion, control, accuracy and&#xD;
      coordination and is expected to reduce the prevalence and operational impact of neck pain in&#xD;
      the intervention group more effectively than does standard care alone.&#xD;
&#xD;
      The proposed study will be designed as a randomized, controlled trial (RCT). Sixty fighter&#xD;
      and helicopter pilots will be randomized into two groups, to receive either standard&#xD;
      physiotherapy and medical care or standard care with the addition of interactive, dynamic,&#xD;
      controlled training (a self-exercise program) in VR to address the fast, accurate head&#xD;
      control required in flying tasks.&#xD;
&#xD;
      Subjective outcome measures will include pain intensity and global perceived effect.&#xD;
      Objective measures will include range of motion, motion velocity and accuracy. The functional&#xD;
      measure will include days grounded due to neck pain.&#xD;
&#xD;
      Statistical analysis will use independent, repeated measures ANOVA on each parameter, within&#xD;
      and between groups. Post hoc comparisons, including several preplanned contrasts, will be&#xD;
      performed to assess differences before and after treatment, and the stability of changes over&#xD;
      time, in each group. The relationship of risk factors to performance failures will be&#xD;
      assessed using multivariate logistic regression analyses.&#xD;
&#xD;
      This study is the first in the Israeli Air Force to evaluate this type of comprehensive,&#xD;
      functional intervention program. Such research will dramatically advance the military's&#xD;
      health care approach to neck pain, and may be further applied to other populations in and&#xD;
      outside the Israeli Defence Force (IDF). This study may serve as a stepping stone to further&#xD;
      research related to diagnosis, treatment, and prevention methods during a pilot's active&#xD;
      service.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 1, 2016</start_date>
  <completion_date type="Actual">December 30, 2017</completion_date>
  <primary_completion_date type="Actual">December 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity is measured using the Visual Analogue Scale (VAS, 0-100mm)</measure>
    <time_frame>change from baseline at 4 weeks, 3 and 6 months.</time_frame>
    <description>Pain intensity was measured using the Visual Analogue Scale (VAS, 0-100mm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Global perceived effect of the provided treatment is measured on a scale from -5 to +5.</measure>
    <time_frame>change from baseline at 4 weeks, 3 and 6 months.</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional outcome is measured by the number of grounding days from flying due to neck pain.</measure>
    <time_frame>change from baseline at 4 weeks, 3 and 6 months.</time_frame>
    <description>The number of days the pilot was grounded due to neck pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cervical range of motion is measured using the neck VR system (ROM, degrees)</measure>
    <time_frame>change from baseline at 4 weeks, 3 and 6 months.</time_frame>
    <description>Cervical range of motion (ROM, degrees) is measured using the neck VR system, into flexion, extension, right and left rotation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cervical motion velocity is measured using the neck VR system (degrees/second)</measure>
    <time_frame>change from baseline at 4 weeks, 3 and 6 months.</time_frame>
    <description>Cervical motion velocity is measured using the neck VR system (degrees/second) into flexion, extension, right and left rotation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cervical muscles isometric strength is measures using a dynamometer (Newton)</measure>
    <time_frame>change from baseline at 4 weeks, 3 and 6 months.</time_frame>
    <description>Cervical muscles isometric strength is measures using a dynamometer (Newton), in the directions of static flexion and extension.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Neck Pain</condition>
  <condition>Cervical Pain</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interactive virtual reality training</intervention_name>
    <description>The proposed VR intervention program will provide active training to be performed individually 4 times a week for 20 minutes a session.&#xD;
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.</description>
    <arm_group_label>intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>physiotherapy and medical care as provided currently</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  fighter and helicopter pilots from the Israeli Air Force&#xD;
&#xD;
          -  acute, sub-acute, and chronic neck pain, with or without referral to the upper limbs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neurological disorders (e.g. evidence for positive neurological signs), systemic&#xD;
             disease, history of spinal surgery, or any disorders that may limit the ability to&#xD;
             exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hilla Sarig-Bahat, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Physical Therapy, University of Haifa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Faculty of Social Welfare and Health Sciences</name>
      <address>
        <city>Haifa</city>
        <zip>3498838</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Aviation Unit</name>
      <address>
        <city>Tel Hashomer</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>20108843</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22594136</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22779315</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>3178626</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21112430</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>10658420</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19770596</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>14736129</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>9795549</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25066503</PMID>
  </reference>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>October 5, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>May 23, 2018</last_update_submitted>
  <last_update_submitted_qc>May 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>neck pain</keyword>
  <keyword>Virtual reality</keyword>
  <keyword>Range of motion</keyword>
  <keyword>physiotherapy</keyword>
  <keyword>Air force</keyword>
  <keyword>kinematics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neck Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02979041
org study id: UHaifaAF
nct id: NCT02979041
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Pain intensity is measured using the Visual Analogue Scale (VAS, 0-100mm)
time frame: change from baseline at 4 weeks, 3 and 6 months.
description: Pain intensity was measured using the Visual Analogue Scale (VAS, 0-100mm)
measure: 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.
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.
measure: 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.
description: The number of days the pilot was grounded due to neck pain.
measure: 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.
description: Cervical range of motion (ROM, degrees) is measured using the neck VR system, into flexion, extension, right and left rotation.
measure: Cervical motion velocity is measured using the neck VR system (degrees/second)
time frame: change from baseline at 4 weeks, 3 and 6 months.
description: Cervical motion velocity is measured using the neck VR system (degrees/second) into flexion, extension, right and left rotation.
measure: Cervical muscles isometric strength is measures using a dynamometer (Newton)
time frame: change from baseline at 4 weeks, 3 and 6 months.
description: Cervical muscles isometric strength is measures using a dynamometer (Newton), in the directions of static flexion and extension.
arm group label: control
arm group type: Active Comparator
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 group label: intervention
arm group type: Experimental
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: Interactive virtual reality training
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.
arm group label: intervention
intervention type: Other
intervention name: Standard Care
description: physiotherapy and medical care as provided currently
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hilla Sarig-Bahat, PT, PhD
role: Principal Investigator
affiliation: Department of Physical Therapy, University of Haifa
facility: 
facility: 
country: Israel
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.
PMID: 20108843
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.
PMID: 22594136
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.
PMID: 22779315
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.
PMID: 3178626
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.
PMID: 21112430
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.
PMID: 10658420
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.
PMID: 19770596
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.
PMID: 14736129
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.
PMID: 9795549
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.
PMID: 25066503
responsible party type: Sponsor
mesh term: Neck Pain
sharing ipd: No