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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Pain
• Intervention / Treatment: Device: Cervical collar

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • MoRe Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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	Device: Cervical collar; Data will be recorded while patients are not wearing or wearing one of two cervical collars

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: More Foundation
• Collaborators: DJO LLC
• Investigators: Study Director: Marc Jacofsky, PhD, MoRe Foundation

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2018
• Primary Completion (Actual): January 9, 2019
• Study Completion (Actual): November 2, 2019

Study Registration Dates

• First Submitted: September 13, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Neck pain; Cervical collar
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 4029

Drug and device information, study documents

• product manufactured in and exported from the U.S.: Yes