Efficacy of Cervical Epidural Injection and Selective Nerve Root Block

May 1, 2023 updated by: Selin Guven Kose, Diskapi Teaching and Research Hospital

Comparison of the Efficacy of Cervical Epidural Steroid Injection and Selective Nerve Root Block in Patients With Cervical Radicular Pain

Cervical epidural steroid injections are an accepted treatment modality for radicular pain secondary to disc pathology. With the developing ultrasound technology, ultrasound guided cervical selective nerve root block has been successfully used in the treatment of cervical radiculopathy. We aimed to compare the efficacy of cervical interlaminar epidural injections and cervical selective nerve root block.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06110
        • Diskapi Yildirim Beyazit Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Cervical radicular pain based on history and physical exam
  • NRS pain score > 3

Exclusion Criteria:

  • Previous spine surgery
  • Allergic reactions to drugs used in procedure
  • Epidural steroid injection within past 2 years
  • Radiculopathy not resulting from disc pathology (e.g. foraminal stenosis or tumor)
  • Untreated coagulopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Interlaminar cervical epidural steroid injection
Procedure: Interlaminar cervical epidural injection
Fluoroscopy-guided interlaminar cervical epidural injection
Experimental: Cervical selective nerve root block
Procedure: Cervical selective nerve root block
Ultrasound-guided cervical selective nerve root block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in pain
Time Frame: Change from baseline pain score to 6months
Pain assessment will be performed using the Numerical Rating Scale (NRS) score (0 = no pain, 10 = the most severe pain felt).
Change from baseline pain score to 6months

Secondary Outcome Measures

Outcome Measure
Time Frame
Neck Disability Index
Time Frame: baseline to 6 months post-procedure
baseline to 6 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Teaching and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2022

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

April 14, 2022

First Submitted That Met QC Criteria

April 15, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 131/10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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