CRIS Based Evaluation of Cervical Interlaminar Epidural Steroid Injection Outcomes

June 9, 2026 updated by: Saglik Bilimleri Universitesi

Simultaneous Evaluation Neck and Arm Symptoms Using the Cervical Radiculopathy ımpact Scale: A Prospective Study on the Efficacy of Cervical Interlaminar Epidural Steroid Injection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective single-center study evaluates the effectiveness of fluoroscopy-guided cervical interlaminar epidural steroid injection (CIESI) in patients with unilateral, single-level cervical radiculopathy caused by cervical disc herniation and resistant to conservative treatment. The study particularly focuses on the simultaneous assessment of neck and upper extremity symptoms using the Cervical Radiculopathy Impact Scale (CRIS), a multidimensional patient-reported outcome measure.

Patients meeting the eligibility criteria undergo CIESI using a parasagittal interlaminar approach under fluoroscopic guidance. Clinical evaluations are performed before the procedure and repeated at 3 weeks and 3 months after treatment. Outcome measures include CRIS, Numeric Rating Scale (NRS), Neck Disability Index (NDI), and QuickDASH scores.

The primary objective is to determine the change in CRIS scores following CIESI. Secondary objectives include evaluating changes in pain severity, neck disability, and upper extremity function after the intervention. The study also investigates the relationship between CRIS improvement and changes in conventional outcome measures to assess the responsiveness and clinical utility of CRIS in cervical radiculopathy.

Study Type

Interventional

Enrollment (Actual)

98

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 (Türkiye)
      • Ankara, Turkey (Türkiye)
        • University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology, Ankara, Etlik 06010

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Age between 18 and 65 years Unilateral single-level cervical disc herniation confirmed by cervical MRI Cervical radicular pain associated with neck pain persisting for at least 6 months Symptoms refractory to conservative treatment, including oral medications and physical therapy Baseline Numeric Rating Scale (NRS) score ≥6 Undergoing fluoroscopy-guided cervical interlaminar epidural steroid injection Ability to complete study questionnaires and attend follow-up visits Written informed consent provided by the participant

Exclusion Criteria:Multilevel cervical disc disease Advanced cervical spinal stenosis Previous cervical spine surgery Cervical epidural steroid injection within the previous 6 months Incomplete procedure due to vasovagal reaction or technical failure Incomplete clinical records or unavailable cervical MRI data Inability to complete follow-up assessments or questionnaires Refusal to provide informed consent

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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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cervical Interlaminar Epidural Steroid Injection
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cervical Radiculopathy Impact Scale (CRIS) Score
Time Frame: Baseline to 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Numeric Rating Scale (NRS) Score
Time Frame: Baseline to 3 months
The Numeric Rating Scale (NRS) was used to assess pain intensity before and after cervical interlaminar epidural steroid injection. Scores range from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain severity. Min-max score: 0/10
Baseline to 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neck Disability Index (NDI) Score
Time Frame: Baseline to 3 months
The Neck Disability Index (NDI) was used to assess changes in neck-related functional disability following cervical interlaminar epidural steroid injection. Higher scores indicate greater disability. min-max score: 0/50
Baseline to 3 months
Change in QuickDASH Score
Time Frame: Baseline to 3 months
The Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire was used to evaluate changes in upper extremity function and symptoms following cervical interlaminar epidural steroid injection. Higher scores indicate greater disability. Min-max score: 0-100
Baseline to 3 months

Collaborators and Investigators

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

Sponsor

Saglik Bilimleri Universitesi

Investigators

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

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)

September 15, 2024

Primary Completion (Actual)

July 15, 2025

Study Completion (Actual)

July 15, 2025

Study Registration Dates

First Submitted

May 18, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEAH-ALGO-CRIS-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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