Comparison of Cervical Motion Restriction and Interface Pressure Between Two Cervical Collars
Completed
Conditions studied: Cervical Pain
In brief
Cervical orthoses are used to restrict motion for the purpose of preventing spinal instability following trauma or pre- and post-surgery or to protect from pain. Modern cervical orthoses are able to effectively restrict motion of the head however load is concentrated on areas of occipital tissue and may, with long term wear, lead to tissue breakdown in the form of pressure ulcers. Previous research has shown that the Miami J collar (Össur Americas Foothill Ranch, CA) effectively reduced cervical movement while providing superior pressure relief. As new cervical orthoses are developed and become commercially available it is useful to examine their performance in comparison to existing well-tested devices. DJO Global (Vista, CA) have recently developed a cervical collar. The purpose of this study is to compare the ability of this newly developed collar to restrict cervical range of motion while at the same time limit the tissue interface pressure exerted by the collar on patients when they are in an upright seated or supine position Data will be collected in a fully equipped 3D motion analysis laboratory. Cervical range of motion will be tracked and analyzed. Interface pressures between the head and collar will be measured using custom pressure mats.
Key facts
- Study ID
- NCT04572113
- Run by
- More Foundation
- People needed
- 12
- Starts
- 2018-11-30
- Expected to finish
- 2019-11-02
- Last updated by the study team
- 2021-08-23
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- English speaking.
- Subjects who have read and signed IRB approved informed consent for this study.
You may not qualify if…
- History of neck pain or neck injury requiring medical care within the previous 12 months.
- History of spinal surgery, physical or chiropractic therapy of the neck.
- History of cervical spondylosis or osteoporosis.
- Pregnant.
- Currently Incarcerated
Where it is running
- MORE Foundation — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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