NCT07535476

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

8.3 years

First QC Date

April 10, 2026

Last Update Submit

April 10, 2026

Conditions

Keywords

Interventional Pain ManagementTreatment OutcomeInjections, SpinalInjection, Epidural

Outcome Measures

Primary Outcomes (1)

  • Treatment response at 6 months (IMMPACT-defined responder rate)

    Responder defined as ≥50% reduction or ≥4-point decrease in NRS-11 compared with baseline.

    6 months

Secondary Outcomes (1)

  • Change in NRS-11 pain score from baseline

    Baseline, 1 months, and 6 months

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pain Medicine, Mersin University Faculty of Medicine

Mersin, Ciftlikkoy, 33110, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 39671525BACKGROUND
  • 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.

    PMID: 38324787BACKGROUND
  • 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.

    PMID: 36122265BACKGROUND

MeSH Terms

Conditions

RadiculopathyNeck Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 17, 2026

Study Start

January 1, 2018

Primary Completion

April 1, 2026

Study Completion

April 10, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations