CompletedNot Applicable

Collar Use for Cervical Radicular Pain

United States71 participantsStarted 2017-08-30

Plain-language summary

To evaluate the effectiveness of treatment in subjects with cervical radicular pain with Vista Therapy Collar, using a Visual Analog Scale, a Neck Disability Index and the SF-36 quality of life survey.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age greater than 18 years
✓. Cervical radicular pain as defined by neck pain radiating to one arm with at least one of the following:
✓. Neck Disability Index (NDI) score \>= 10 points
✓. VAS for neck pain \>= 40
✓. Subject has signed and dated the Patient Informed Consent /Patient Information Sheet prior to any study-related activities being conducted
✓. Subject is willing and able to attend visits as scheduled and to comply with the study protocol

Exclusion criteria

✕. Serious somatic or psychiatric disorder
✕. Previous Neck Surgery
✕. Whiplash as the primary incident
✕. History of spinal tumor or infection
✕. Cervical Instability per opinion of PI
✕. Morbid Obesity (BMI\>40)
✕. TMJ issues
✕. Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study

What they're measuring

Neck Disability Index (NDI)

Timeframe: 90 days

SF-36 Quality of Life Survey

Timeframe: 90 days

Visual Analog Scale (VAS)

Timeframe: 90 days

Trial details

NCT IDNCT04163939

SponsorRhode Island Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-01

View on ClinicalTrials.gov More Cervical Radiculopathy trials