Back to resultsCollar Use for Cervical Radicular Pain
Primary Purpose
Cervical Radiculopathy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vista Therapy Collar
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Radiculopathy focused on measuring Neck pain
Eligibility Criteria
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:
- 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
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
- 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
Sites / Locations
- Comprehensive Spine Center, Rhode Island Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Collar
Control
Arm Description
This group will wear a cervical collar for at least 30 minutes per day, 5 out of 7 days of the week
This group will not wear the cervical collar
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04163939
First Posted
November 1, 2019
Last Updated
January 27, 2023
Sponsor
Rhode Island Hospital
Collaborators
Synovation Medical Group
1. Study Identification
Unique Protocol Identification Number
NCT04163939
Brief Title
Collar Use for Cervical Radicular Pain
Official Title
A Randomized Controlled Trial of Collar Use for Cervical Radicular Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
Collaborators
Synovation Medical Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
Keywords
Neck pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
To evaluate the effectiveness of treatment with Vista Therapy Collar for indication of cervical radicular pain, defined as pain radiating into one or both upper extremities compared to standard care.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Collar
Arm Type
Experimental
Arm Description
This group will wear a cervical collar for at least 30 minutes per day, 5 out of 7 days of the week
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
This group will not wear the cervical collar
Intervention Type
Other
Intervention Name(s)
Vista Therapy Collar
Intervention Description
The patient will wear the cervical collar
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The patient will not wear the cervical collar
Primary Outcome Measure Information:
Title
Neck Disability Index (NDI)
Description
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.
Time Frame
90 days
Title
SF-36 Quality of Life Survey
Description
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.
Time Frame
90 days
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
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
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
Facility Information:
Facility Name
Comprehensive Spine Center, Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Collar Use for Cervical Radicular Pain
We'll reach out to this number within 24 hrs