- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07535476
Predictors of Clinical Response After Interlaminar Cervical Epidural Steroid Injection for Cervical Radiculopathy (M-DICER)
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
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ciftlikkoy
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Mersin, Ciftlikkoy, Turkey (Türkiye), 33110
- Department of Pain Medicine, Mersin University Faculty of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Treatment response at 6 months (IMMPACT-defined responder rate)
Time Frame: 6 months
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Responder defined as ≥50% reduction or ≥4-point decrease in NRS-11 compared with baseline.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in NRS-11 pain score from baseline
Time Frame: Baseline, 1 months, and 6 months
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NRS-11 ranges from 0 (no pain) to 10 (worst imaginable pain).
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Baseline, 1 months, and 6 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Yolcu G, Toprak CS, Sencan S, Gunduz OH. Dry Needling Plus Cervical Interlaminar Epidural Steroid Injections: Do We Have More Favorable Results in Cervical Disc Herniation? A Randomized Sham-Controlled Clinical Study. Am J Phys Med Rehabil. 2024 Dec 1;103(12):1081-1087. doi: 10.1097/PHM.0000000000002509.
- Yildiz G, Perdecioglu GRG, Akkaya OT, Can E, Yuruk D. Comparison of Selective Nerve Root Pulsed Radiofrequency Vs Paramedian Interlaminar Epidural Steroid Injection for the Treatment of Painful Cervical Radiculopathy. Pain Physician. 2024 Feb;27(2):E221-E229.
- Sacaklidir R, Sanal-Toprak C, Yucel FN, Gunduz OH, Sencan S. The Effect of Central Sensitization on Interlaminar Epidural Steroid Injection Treatment Outcomes in Patients with Cervical Disc Herniation: An Observational Study. Pain Physician. 2022 Sep;25(6):E823-E829.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MERSINALG-CESI -2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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