Collar Use for Cervical Radicular Pain

A Randomized Controlled Trial of Collar Use for Cervical Radicular Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Radiculopathy
• Intervention / Treatment: Other: Vista Therapy Collar; Other: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Darlene A Gaudet, BS,MS; Phone Number: 401-793-9179; Email: Dgaudet@lifespan.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Comprehensive Spine Center, Rhode Island Hospital
      • Contact: Alexios G Carayannopoulos, DO, MPH; Phone Number: 401-793-9836
      • Principal Investigator: Alexios G Carayannopoulos, DO, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Collar; This group will wear a cervical collar for at least 30 minutes per day, 5 out of 7 days of the week	Other: Vista Therapy Collar; The patient will wear the cervical collar
Placebo Comparator: Control; This group will not wear the cervical collar	Other: Placebo; The patient will not wear the cervical collar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: Synovation Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2017
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Neck pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: 1426278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No