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Efficacy of Cervical Epidural Injection and Selective Nerve Root Block

Sponsor
Diskapi Teaching and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05340179
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
8.2
Anticipated Duration (Months)
7.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Interlaminar cervical epidural injection
  • Procedure: Cervical selective nerve root block
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of the Efficacy of Cervical Epidural Steroid Injection and Selective Nerve Root Block in Patients With Cervical Radicular Pain
Actual Study Start Date :
Apr 25, 2022
Anticipated Primary Completion Date :
Dec 20, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Reduction in pain [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).

Secondary Outcome Measures

  1. Neck Disability Index [baseline to 6 months post-procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Diskapi Yildirim Beyazit Training and Research Hospital Ankara Turkey 06110

Sponsors and Collaborators

  • Diskapi Teaching and Research Hospital

Investigators

  • Principal Investigator: selin guven kose, Diskapi Yildirim Beyazit Education and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Selin Guven Kose, principal Investigator, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT05340179
Other Study ID Numbers:
  • 131/10
First Posted:
Apr 22, 2022
Last Update Posted:
May 25, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Radiculopathy

Study Results

No Results Posted as of May 25, 2022