Neck PainNCT02979041
VR Training for Pilots With Neck Pain
A study testing Interactive virtual reality training in people with Neck Pain and Cervical Pain, run by University of Haifa at 2 sites in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain, Cervical Pain
- What is being tested?
- Interactive virtual reality training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Sep 2016to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fighter and helicopter pilots from the Israeli Air Force
- acute, sub-acute, and chronic neck pain, with or without referral to the upper limbs
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
The Faculty of Social Welfare and Health Sciences
Haifa, 3498838
Medical Aviation Unit
Tel Litwinsky
About this study
Official title: Therapeutic Virtual Reality Training for Neck Pain in Israeli Air Force Pilots - A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Neck Pain, Cervical Pain
- Being tested
- Interactive virtual reality training, Standard Care
- Keywords
- neck pain, Virtual reality, Range of motion, physiotherapy, Air force, kinematics
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive virtual reality trainingBehavioural
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 CareOther
physiotherapy and medical care as provided currently
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Interactive virtual reality training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity is measured using the Visual Analogue Scale (VAS, 0-100mm)
Pain intensity was measured using the Visual Analogue Scale (VAS, 0-100mm)
Measured: 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.
Measured: 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.
Measured: 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)
Cervical range of motion (ROM, degrees) is measured using the neck VR system, into flexion, extension, right and left rotation.
Measured: change from baseline at 4 weeks, 3 and 6 months.
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.
Measured: change from baseline at 4 weeks, 3 and 6 months.
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.
Measured: change from baseline at 4 weeks, 3 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study start1 Sep 2016
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Corps, Israel Defense Force
- Responsible party
- Sponsor
- Investigators
- Hilla Sarig-Bahat, PT, PhD, Principal investigator, Department of Physical Therapy, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979041
- Sponsor's protocol ID
- UHaifaAF
- Status last verified
- Jun 2016
- First submitted
- 5 Oct 2016
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 20108843Tucker 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.
PubMed 22594136Grossman 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.
PubMed 22779315Knudson 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.
PubMed 3178626Sarig 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.
PubMed 21112430Jones 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.
PubMed 10658420Ang 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.
PubMed 19770596Alricsson 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.
PubMed 14736129Hamalainen O, Heinijoki H, Vanharanta H. Neck training and +Gz-related neck pain: a preliminary study. Mil Med. 1998 Oct;163(10):707-8.
PubMed 9795549Sarig 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.
PubMed 25066503
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Virtual Reality Training for Neck Pain in Israeli Air Force Pilots - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02979041
- Acronym / sponsor ID
- UHaifaAF
- Conditions
- Neck Pain, Cervical Pain
- Keywords
- neck pain, Virtual reality, Range of motion, physiotherapy, Air force, kinematics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Medical Corps, Israel Defense Force
- Study start
- 1 Sep 2016
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 1 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Other: Standard CarePatients 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. |
| intervention | Experimental | Behavioral: Interactive virtual reality trainingStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- fighter and helicopter pilots from the Israeli Air Force
- acute, sub-acute, and chronic neck pain, with or without referral to the upper limbs
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive virtual reality trainingThe 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. | Behavioural | intervention |
| Standard Carephysiotherapy and medical care as provided currently | Other | control |
Primary outcome
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)
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.
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.
3 secondary outcomes
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 motion velocity is measured using the neck VR system (degrees/second)
Time frame: change from baseline at 4 weeks, 3 and 6 months.
Cervical muscles isometric strength is measures using a dynamometer (Newton)
Time frame: change from baseline at 4 weeks, 3 and 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
- Background: PubMed 20108843van 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.
- Background: PubMed 22594136Tucker 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.
- Background: PubMed 22779315Grossman 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.
- Background: PubMed 3178626Knudson 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.
- Background: PubMed 21112430Sarig 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.
- Background: PubMed 10658420Jones 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.
- Background: PubMed 19770596Ang 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.
- Background: PubMed 14736129Alricsson 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.
- Background: PubMed 9795549Hamalainen O, Heinijoki H, Vanharanta H. Neck training and +Gz-related neck pain: a preliminary study. Mil Med. 1998 Oct;163(10):707-8.
- Background: PubMed 25066503Sarig 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilla Sarig-Bahat, PT, PhD principal investigator
Department of Physical Therapy, University of Haifa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive virtual reality training in people with Neck Pain and Cervical Pain, run by University of Haifa at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02979041, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018; AzTrials last refreshed its copy on 30 Oct 2026.