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NCT02226159 · ClinicalTrials.gov registry record · Phase 4
Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain
A Phase 4 study, sponsored by OrthoCarolina Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 65
- Enrollment target
NCT02226159 is a Phase 4 study that has completed, run by OrthoCarolina Research Institute. The registered enrollment target is 65 participants.
The verdict
NCT02226159, a Phase 4 study, has completed, sponsored by OrthoCarolina Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 65 participants
- Enrollment target
Study Summary
Cervical radicular pain is a common cause of disability and pain in the upper extremity and neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and includes relative rest, use of anti-inflammatory and analgesic medication, as well as physical therapy and home exercise. For patients who have persistent and significant symptoms, interventional pain management and surgical management are considered. Cervical epidural injections are the mainstay of the interventional, non-surgical modalities. They can be considered to provide short and long-term relief when disc herniation, foraminal stenosis or central canal stenosis pathology is identified. We are not aware of any published prospective, randomized, controlled, double-blinded studies demonstrating the efficacy of cervical transforaminal epidural steroid injections. However, the North American Spine Society (NASS) Review and Recommendation Statement states that based on the literature and expert opinion, a minimum of one or two cervical epidural steroid injections would be very appropriate in the treatment of a specific episode of cervical radicular pain. The purpose of this study is to determine the effectiveness of cervical transforaminal epidural steroid injections in decreasing the need for an operation in patients with cervical radicular pain, otherwise considered to be operative candidates.
Interventions
- DRUG Lidocaine
- DRUG Lidocaine with Dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2014-08 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02226159
The ClinicalTrials.gov registry entry for NCT02226159 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OrthoCarolina Research Institute, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lidocaine is the first listed.
NCT02226159 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02226159 about?
NCT02226159 is a clinical study titled "Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain". Cervical radicular pain is a common cause of disability and pain in the upper extremity and neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and includes relative rest, use of anti-inflammatory and analgesic medication, as well as physical therapy and home exe...
What is the current status of trial NCT02226159?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 65 participants. The study started on 2014-08. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT02226159?
The interventions under investigation include: Lidocaine (DRUG), Lidocaine with Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT02226159?
This trial is sponsored by OrthoCarolina Research Institute, which has 28 total clinical trials registered on ClinicalTrials.gov.
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