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

NCT04572113 | Completed

• 1 other identifier: 4029
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Pain

Keywords

Neck pain; Cervical collar

Outcome Measures

Primary Outcomes (2)

• Cervical range of motion

  The subjects will be seated in a backed chair and monitored to ensure their spine remains in contact with the backrest throughout the CROM assessment. Each subject will be instructed to perform a sequence of of neck flexion-extension, lateral flexion, and rotation movements. Each movement will be repeated six times until the motion is stopped by muscle tightness, discomfort or a substitution movement occurs, without a collar, and with each study collar chosen chosen in random order. Angular range of motion in degrees will be recorded in each plane. Flexion-extension - angle between maximum flexion and maximum extension. Lateral flexion - angle between maximum right lateral flexion and maximum left lateral flexion. Rotation - angle between maximum right rotation and maximum left rotation.

  At enrollment

• Tissue interface pressure

  With the subject seated, 3, 75 x 120mm pressure sensor pads, each pad each consisting of 40 individual sensors; will be placed over the anterior mandibles and occiput. The subject will be fit with an appropriately sized collar. The order of collar wear will be the same as for the CROM measurements. Pressure measurements and distribution of pressure will be recorded for a period of 30 seconds. The subject will then be placed in a supine position on a standard examination table without a pillow and pressure measurements and distribution of pressure will be collected for a period of 30 seconds while the subject maintains his/her head in a relaxed position.

  At enrollment

Study Arms (3)

No collar

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

DJO collar

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

Device: Cervical collar

Miami J collar

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

Device: Cervical collar

Interventions

Cervical collar DEVICE

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

DJO collar; Miami J collar

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited by word of mouth from the surrounding general population and may include staff of MORE Foundation and The CORE Institute.

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

Sponsors & Collaborators

• More Foundation: lead
• DJO LLC: collaborator

Study Sites (1)

MORE Foundation

Phoenix, Arizona, 85023, United States

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Jacofsky, PhD

  More Foundation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: October 1, 2020
• Study Start: November 30, 2018
• Primary Completion: January 9, 2019
• Study Completion: November 2, 2019
• Last Updated: August 23, 2021

Record last verified: 2020-09

Locations

US (1)