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Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain

NCT02226159 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-08-11

Study results available
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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.

Conditions

  • Pain, Radiating

Interventions

DRUG

Lidocaine

DRUG

Lidocaine with Dexamethasone

Sponsors & Collaborators

  • Charlotte Surgery Center

    collaborator OTHER

  • OrthoCarolina Research Institute, Inc.

    lead OTHER

Principal Investigators

  • Sam Bhagia, MD · OrthoCarolina Research Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2019-05-31
Completion
2024-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02226159 on ClinicalTrials.gov