Collar Use for Cervical Radicular Pain
Completed · Not applicable · Has a placebo group
Conditions studied: Cervical Radiculopathy
In brief
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.
Key facts
- Study ID
- NCT04163939
- Run by
- Rhode Island Hospital
- People needed
- 71
- Starts
- 2017-08-30
- Expected to finish
- 2022-12-01
- Last updated by the study team
- 2023-01-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age greater than 18 years
- Cervical radicular pain as defined by neck pain radiating to one arm with at least one of the following:
- Provocation by neck movements or sensory changes in one or more adjacent dermatomes or diminished deep tendon reflexes in the affected arm.
- Muscle weakness in one or more adjacent myotomes.
- 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
You may not qualify if…
- 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
- Subject is involved in current litigation regarding neck pain or injuries associated with neck pain
- Subject is involved in Worker's Compensation litigation
- Non-English speaking
Where it is running
- Comprehensive Spine Center, Rhode Island Hospital — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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