CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 65 enrolled
Drug / intervention
Lidocaine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02226159
NCT02226159Phase 4Completed

Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain (SPIES): a Randomized, Controlled Trial

OrthoCarolina Research Institute, Inc.·interventional·Posted Aug 27, 2014·Updated Aug 11, 2025

In Brief

A Phase 4 clinical trial evaluating Lidocaine and Lidocaine with Dexamethasone for Pain, Radiating. Completed, enrolled 65 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Radiating
CountriesUnited States

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 27, 2014
Enrollment StartAug 1, 2014
Primary CompletionMay 1, 2019
Study CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 11.8 years ago

Interventions

Lidocainedrug

Lidocaine with Dexamethasonedrug