Collar Use for Cervical Radicular Pain

Cervical Radiculopathy Clinical Trial

Official title:

A Randomized Controlled Trial of Collar Use for Cervical Radicular Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04163939
• Other study ID #: 1426278
• Status: Completed
• Phase: N/A
• Start date: August 30, 2017
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2023
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

Other:
• Vista Therapy Collar
The patient will wear the cervical collar
• Placebo
The patient will not wear the cervical collar

Locations

Country	Name	City	State
United States	Comprehensive Spine Center, Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	Synovation Medical Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck Disability Index (NDI)	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.	90 days
Primary	SF-36 Quality of Life Survey	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.	90 days
Primary	Visual Analog Scale (VAS)	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.	90 days