Collar Use for Cervical Radicular Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-30

Study Completion Date

2022-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cervical Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Collar

This group will wear a cervical collar for at least 30 minutes per day, 5 out of 7 days of the week

Group Type EXPERIMENTAL

Vista Therapy Collar

Intervention Type OTHER

The patient will wear the cervical collar

Control

This group will not wear the cervical collar

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

The patient will not wear the cervical collar

Interventions

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Vista Therapy Collar

The patient will wear the cervical collar

Intervention Type OTHER

Placebo

The patient will not wear the cervical collar

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Alexios Carayannopoulos

Medical Director, Comprehensive Spine Center; Chief of Physical Medicine and Rehabilitation Medicine, Chief of Lifespan Physican Group, Rhode Island Hospital, Newport Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR