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| Name | Class |
|---|---|
| Synovation Medical Group | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collar | Experimental | This group will wear a cervical collar for at least 30 minutes per day, 5 out of 7 days of the week |
|
| Control | Placebo Comparator | This group will not wear the cervical collar |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vista Therapy Collar | Other | The patient will wear the cervical collar |
| |
| 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 |
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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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Spine Center, Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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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.
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| Placebo |
| Other |
The patient will not wear the cervical collar |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |