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

More Foundation

Status: Completed

Conditions: Cervical Pain

Treatments: Device: Cervical collar

Study type: Observational

Funder types: Other

Identifiers

NCT04572113

4029

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

12 participants in 3 patient groups

No collar

Description:

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

DJO collar

Description:

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

Treatment:

Device: Cervical collar

Miami J collar

Description:

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

Treatment:

Device: Cervical collar