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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: Completed Phase 4 study, sponsored by OrthoCarolina Research Institute.

NCT02226159 is a Phase 4 study that has completed, run by OrthoCarolina Research Institute. The registered enrollment target is 65 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The primary outcome variable is the avoidance of surgery. Treatment success is defined as the avoidance of surgery, while treatment failure is defined as having surgery due to failure of the injection treatment to alleviate pain and improve function over the 12 months they are being followed for purposes of this study. Avoided neck surgery noted as 'Yes'; avoided neck surgery 'No' the patient had neck surgery.

Interventions

  • DRUG Lidocaine
  • DRUG Lidocaine with Dexamethasone

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2014-08
Est. Completion 2024-12-31
Phase Phase 4
OrthoCarolina Research Institute

28 total trials

What the finished NCT02226159 record still lists

NCT02226159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 2 interventions - of which Lidocaine is the first listed.

NCT02226159 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02226159's enrollment target sits among peer trials

65 1091st of 2000 higher than 903 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02226159, the US trial registry maintained by the National Library of Medicine. NCT02226159 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.