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Completed

NCT Number: NCT04163939

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.

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Key information

Conditions

Cervical Radiculopathy Neck Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Comprehensive Spine Center, Rhode Island Hospital

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vista Therapy Collar

Other

The patient will wear the cervical collar

Placebo

Other

The patient will not wear the cervical collar

Primary outcomes

  1. Neck Disability Index (NDI)

    Time frame: 90 days

    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.

  2. SF-36 Quality of Life Survey

    Time frame: 90 days

    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.

  3. Visual Analog Scale (VAS)

    Time frame: 90 days

    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.

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • Synovation Medical Group

Registry information

Official study title

A Randomized Controlled Trial of Collar Use for Cervical Radicular Pain

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2019
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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