Collar Use for Cervical Radicular Pain

NCT04163939 | Completed

• 1 other identifier: 1426278
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Radiculopathy

Keywords

Neck pain

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Collar

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

This group will not wear the cervical collar

Other: Placebo

Interventions

Vista Therapy Collar OTHER

The patient will wear the cervical collar

Collar

Placebo OTHER

The patient will not wear the cervical collar

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Synovation Medical Group: collaborator

Study Sites (1)

Comprehensive Spine Center, Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Radiculopathy; Neck Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Comprehensive Spine Center; Chief of Physical Medicine and Rehabilitation Medicine, Chief of Lifespan Physican Group, Rhode Island Hospital, Newport Hospital

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 15, 2019
• Study Start: August 30, 2017
• Primary Completion: April 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)