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Efficacy of Cervical Epidural Injection and Selective Nerve Root Block

Primary Purpose

Cervical Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Interlaminar cervical epidural injection
Cervical selective nerve root block
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Diskapi Yildirim Beyazit Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Interlaminar cervical epidural steroid injection

Cervical selective nerve root block

Arm Description

Outcomes

Primary Outcome Measures

Reduction in pain
Pain assessment will be performed using the Numerical Rating Scale (NRS) score (0 = no pain, 10 = the most severe pain felt).

Secondary Outcome Measures

Neck Disability Index

Full Information

First Posted
April 14, 2022
Last Updated
May 1, 2023
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05340179
Brief Title
Efficacy of Cervical Epidural Injection and Selective Nerve Root Block
Official Title
Comparison of the Efficacy of Cervical Epidural Steroid Injection and Selective Nerve Root Block in Patients With Cervical Radicular Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interlaminar cervical epidural steroid injection
Arm Type
Active Comparator
Arm Title
Cervical selective nerve root block
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Interlaminar cervical epidural injection
Intervention Description
Fluoroscopy-guided interlaminar cervical epidural injection
Intervention Type
Procedure
Intervention Name(s)
Cervical selective nerve root block
Intervention Description
Ultrasound-guided cervical selective nerve root block
Primary Outcome Measure Information:
Title
Reduction in pain
Description
Pain assessment will be performed using the Numerical Rating Scale (NRS) score (0 = no pain, 10 = the most severe pain felt).
Time Frame
Change from baseline pain score to 6months
Secondary Outcome Measure Information:
Title
Neck Disability Index
Time Frame
baseline to 6 months post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
selin guven kose
Organizational Affiliation
Diskapi Yildirim Beyazit Education and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diskapi Yildirim Beyazit Training and Research Hospital
City
Ankara
ZIP/Postal Code
06110
Country
Turkey

12. IPD Sharing Statement

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Efficacy of Cervical Epidural Injection and Selective Nerve Root Block

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