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Completed

NCT Number: NCT07535476

Predictors of Clinical Response After Interlaminar Cervical Epidural Steroid Injection for Cervical Radiculopathy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pain Medicine, Mersin University Faculty of Medicine

Mersin, Ciftlikkoy, 33110, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

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

Acronym: M-DICER

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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