CRIS Based Evaluation of Cervical Interlaminar Epidural Steroid Injection Outcomes

NCT07639671 | Completed

• 1 other identifier: GEAH-ALGO-CRIS-4
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cervical radiculopathy; neck pain; arm pain; epidural injection; cervical radiculopathy impact scale

Outcome Measures

Primary Outcomes (1)

• Change in Cervical Radiculopathy Impact Scale (CRIS) Score

  The Cervical Radiculopathy Impact Scale (CRIS) was used to evaluate changes in neck and upper extremity symptoms and related functional disability following cervical interlaminar epidural steroid injection. Higher scores indicate greater disability and symptom burden. Min-max score: 21/105

  Baseline to 3 months

Secondary Outcomes (1)

• Change in Numeric Rating Scale (NRS) Score

  Baseline to 3 months

Other Outcomes (2)

• Change in Neck Disability Index (NDI) Score

  Baseline to 3 months

• Change in QuickDASH Score

  Baseline to 3 months

Study Arms (1)

Cervical Interlaminar Epidural Steroid Injection

EXPERIMENTAL

Patients with unilateral, single-level cervical radiculopathy due to cervical disc herniation underwent fluoroscopy-guided cervical interlaminar epidural steroid injection using a parasagittal approach. Clinical outcomes were evaluated at baseline, 3 weeks, and 3 months using the Cervical Radiculopathy Impact Scale (CRIS), Numeric Rating Scale (NRS), Neck Disability Index (NDI), and QuickDASH.

Procedure: Cervical Interlaminar Epidural Steroid Injection

Interventions

Cervical Interlaminar Epidural Steroid Injection PROCEDURE

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.

Cervical Interlaminar Epidural Steroid Injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology, Ankara, Etlik 06010

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Radiculopathy; Neck Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alp Eren Celenlioglu, MD, Assoc. Prof

  University of Health Sciences Gulhane Training and Research Hospital, Department of Algology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 10, 2026
• Study Start: September 15, 2024
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: June 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)