Comparison of Cervical Motion Restriction and Interface Pressure Between Two Cervical Collars

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-30

Study Completion Date

2019-11-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Cervical Pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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No collar

Cervical range of motion and tissue interface pressure measurements are recorded while subject are not wearing a cervical collar

No interventions assigned to this group

DJO collar

Cervical range of motion and tissue interface pressure measurements are recorded while subject are wearing a DJO cervical collar

Cervical collar

Intervention Type DEVICE

Data will be recorded while patients are not wearing or wearing one of two cervical collars

Miami J collar

Cervical range of motion and tissue interface pressure measurements are recorded while subject are wearing a Miami J cervical collar

Cervical collar

Intervention Type DEVICE

Data will be recorded while patients are not wearing or wearing one of two cervical collars

Interventions

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Cervical collar

Data will be recorded while patients are not wearing or wearing one of two cervical collars

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* English speaking.
* Subjects who have read and signed IRB approved informed consent for this study.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No