An interventional study of Interactive virtual reality training and Standard Care in Neck Pain and Cervical Pain, sponsored by University of Haifa. Completed at 2 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-24.
Sponsored by University of Haifa · Not applicable, Interventional, and Treatment
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.
1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.
This study's enrollment of 47 is close to the median of 52 across 1,004 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →University of Haifa is the lead sponsor of 101 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
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
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.
physiotherapy and medical care as provided currently
Pain intensity is measured using the Visual Analogue Scale (VAS, 0-100mm)
Pain intensity was measured using the Visual Analogue Scale (VAS, 0-100mm)
Time frame: 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.
Time frame: 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.
Time frame: change from baseline at 4 weeks, 3 and 6 months.
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.
Time frame: 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.
Time frame: 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.
Time frame: change from baseline at 4 weeks, 3 and 6 months.
Plan to share: No
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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University of Haifa