Collar Use for Cervical Radicular Pain

Not Applicable

Completed

• Conditions: Cervical Radiculopathy
• Interventions: Other: Vista Therapy Collar; Other: Placebo

• Registration Number: NCT04163939
• Lead Sponsor: Rhode Island Hospital

Brief 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.

Detailed Description

To evaluate the effective of treatment with Vista Therapy Collar for indication of cervical radicular pain, defined as pain radiating into one or both upper extremities compared to a 'wait and see' approach.

Study Timeline

• Study Start: 2017-08-30
• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2019-11-12
• Study First Posted: 2019-11-15
• Primary Completion: 2022-04-01
• Study Completion: 2022-12-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-27
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

1. Age greater than 18 years

2. 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.

3. Neck Disability Index (NDI) score >= 10 points

4. VAS for neck pain >= 40

5. Subject has signed and dated the Patient Informed Consent /Patient Information Sheet prior to any study-related activities being conducted

6. Subject is willing and able to attend visits as scheduled and to comply with the study protocol

Exclusion Criteria

1. Serious somatic or psychiatric disorder
2. Previous Neck Surgery
3. Whiplash as the primary incident
4. History of spinal tumor or infection
5. Cervical Instability per opinion of PI
6. Morbid Obesity (BMI>40)
7. TMJ issues
8. 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
9. Subject is involved in current litigation regarding neck pain or injuries associated with neck pain
10. Subject is involved in Worker's Compensation litigation
11. Non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collar	Vista Therapy Collar	This group will wear a cervical collar for at least 30 minutes per day, 5 out of 7 days of the week
Control	Placebo	This group will not wear the cervical collar

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	90 days	Scale used to measure pain. The subject will mark their pain on a scale with a length of 100mm. The scale is scored by measuring (mm) from the left end of the scale to the subject's marking. The VAS is scored from 0-100, higher scores signify a greater amount of pain.
Neck Disability Index (NDI)	90 days	Questionnaire used to measure how neck pain affects activities of daily living. Each of the 10 items are scored from 0-5, the maximum score is 50. Higher scores signify greater disability. A score over 34 signifies complete disability.
SF-36 Quality of Life Survey	90 days	Questionnaire used to measure quality of life. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. The total score is calculated as a percentage of the total points possible. A higher total percent signifies better outcomes.

Trial Locations

Locations (1)

Comprehensive Spine Center, Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States