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CRIS Based Evaluation of Cervical Interlaminar Epidural Steroid Injection Outcomes

NCT07639671 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-06-10

No results posted yet for this study

Summary

This prospective single-center study aims to evaluate the clinical efficacy of fluoroscopy-guided cervical interlaminar epidural steroid injection (CIESI) in patients with unilateral, single-level cervical radiculopathy due to cervical disc herniation. Unlike previous studies that assessed neck and arm symptoms separately, this study uses the Cervical Radiculopathy Impact Scale (CRIS) as the primary outcome measure to simultaneously evaluate cervical and upper extremity symptoms and their functional impact. A total of 98 patients resistant to conservative treatment will be assessed at baseline, 3 weeks, and 3 months after CIESI using CRIS, Numeric Rating Scale (NRS), Neck Disability Index (NDI), and QuickDASH scores. The primary outcome is improvement in CRIS scores following the intervention, while secondary outcomes include changes in pain intensity and functional disability. The study seeks to determine whether CRIS provides a more comprehensive and clinically meaningful assessment of treatment response in cervical radiculopathy.

Conditions

  • Cervical Radiculopathy
  • Cervical Disc Herniation
  • Cervical Radicular Pain
  • Chronic Neck Pain

Interventions

PROCEDURE

Cervical Interlaminar Epidural Steroid Injection

Fluoroscopy-guided cervical interlaminar epidural steroid injection was performed at the C7-T1 level using a parasagittal approach. After confirmation of epidural spread with contrast medium under contralateral oblique imaging, a total of 6 mL solution containing dexamethasone, lidocaine, and normal saline was injected into the epidural space. All procedures were performed by an experienced pain specialist, and patients were monitored for possible complications after the procedure.

Sponsors & Collaborators

  • Saglik Bilimleri Universitesi

    lead OTHER

Principal Investigators

  • Alp Eren Celenlioglu, MD, Assoc. Prof · University of Health Sciences Gulhane Training and Research Hospital, Department of Algology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-15
Primary Completion
2025-07-15
Completion
2025-07-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07639671 on ClinicalTrials.gov