Predictors of Clinical Response After Interlaminar Cervical Epidural Steroid Injection for Cervical Radiculopathy (M-DICER)

April 10, 2026 updated by: Mesut Bakır, Mersin University

Predictors of Clinical Response After Interlaminar Cervical Epidural Steroid Injection for Cervical Radiculopathy: A Retrospective Cohort Study

Cervical epidural steroid injection is a commonly used treatment option for patients with cervical radicular pain who do not improve adequately with conservative treatment. Cervical radicular pain typically radiates from the neck to the shoulder, arm, or hand and may be accompanied by numbness, weakness or changes in reflexes. The most common causes are cervical disc herniation and cervical spondylosis. By reducing inflammation around the affected nerve root, epidural steroid injection may help relieve pain and improve function. Among available techniques, the interlaminar approach is frequently preferred in the cervical region because of its technical feasibility and safety profile.

Although interlaminar cervical epidural steroid injection is widely used, treatment response varies among patients, and not all individuals experience the same degree of benefit. Identifying the factors associated with better or poorer clinical response may help improve patient selection and reduce unnecessary procedures.

This retrospective cohort study aims to evaluate clinical outcomes after interlaminar cervical epidural steroid injection in patients with cervical radiculopathy and to investigate demographic, clinical, and procedure-related variables which may predict treatment response. By analyzing pain scores before and after the procedure, this study seeks to better define the predictors of clinical outcome following this intervention.

Study Overview

Detailed Description

This retrospective cohort study will review the medical records of patients who presented to the Pain Clinic of Mersin University Faculty of Medicine Hospital between January 1, 2018, and October 1, 2025, with neck pain related to cervical disc herniation and underwent interlaminar cervical epidural steroid injection.

The study population will consist of adult patients who were diagnosed and/or followed by physicians in the research team, had neck pain associated with cervical disc herniation for at least 1 month and provided written informed consent for the procedure. Patients will be excluded if they had an active infection at the time of injection, a history of allergy to local anesthetic or contrast agents or a bleeding diathesis.

Data will be collected from existing medical records using a standardized data collection form. Variables of interest will include age, sex, duration of pain, clinical diagnosis, type of corticosteroid used, presence of fibromyalgia, use of transcutaneous electrical nerve stimulation (TENS), history of trigger point injection, electromyography findings and Numeric Rating Scale (NRS-11) pain scores recorded before the procedure and at 1-month and 6-month follow-up.

The primary aim of the study is to identify demographic, clinical, and procedure-related factors associated with clinical response after interlaminar cervical epidural steroid injection in patients with cervical radiculopathy related to cervical disc herniation.

Study Type

Observational

Enrollment (Actual)

107

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

    • Ciftlikkoy
      • Mersin, Ciftlikkoy, Turkey (Türkiye), 33110
        • Department of Pain Medicine, Mersin University Faculty of Medicine

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

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients with cervical radiculopathy related to cervical disc herniation who underwent interlaminar cervical epidural steroid injection at the Mersin University Faculty of Medicine, Pain Clinic between January 1, 2018, and October 1, 2025. Only patients who met the predefined inclusion and exclusion criteria and had available pre-procedural, procedural, and post-procedural follow-up data, including Numeric Rating Scale (NRS-11) pain scores, were included in the analysis.

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • Presence of neck and upper extremity pain consistent with cervical radiculopathy
  • Persistence of symptoms for at least 1 month despite conservative treatment
  • Documented baseline NRS-11 pain score prior to the procedure and follow-up NRS-11 data available through at least 6 months after treatment.

Exclusion Criteria:

  • Active infection during the time of injection
  • Allergie to local anesthetics or contrast agents
  • History of bleeding diathesis.
  • Insufficient follow-up data (less than 6 months of follow-up NRS-11 documentation).

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

Cohorts and Interventions

Group / Cohort
Patients Undergoing Cervical Interlaminar Epidural Steroid Injection
This cohort includes eligible patients with cervical radiculopathy due to cervical disc herniation who received interlaminar cervical epidural steroid injection during the study period. In patients who received more than one procedure, only the first injection was analyzed. Clinical response was evaluated retrospectively based on pain scores documented before the procedure and during follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment response at 6 months (IMMPACT-defined responder rate)
Time Frame: 6 months
Responder defined as ≥50% reduction or ≥4-point decrease in NRS-11 compared with baseline.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in NRS-11 pain score from baseline
Time Frame: Baseline, 1 months, and 6 months
NRS-11 ranges from 0 (no pain) to 10 (worst imaginable pain).
Baseline, 1 months, and 6 months

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

January 1, 2018

Primary Completion (Actual)

April 1, 2026

Study Completion (Actual)

April 10, 2026

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made available because the study is based on retrospectively collected medical record data from a single center, and sharing such data may raise confidentiality and privacy concerns.

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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