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NCT Number: NCT07639671

CRIS Based Evaluation of Cervical Interlaminar Epidural Steroid Injection Outcomes

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.

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Key information

Conditions

Cervical Radiculopathy Cervical Disc Herniation Cervical Radicular Pain Chronic Neck Pain Neck Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Of Health Sciences, Gulhane School Of Medicine, Department Of Algology, Ankara, Etlik 06010

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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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Treatment and study plan

Cervical Interlaminar Epidural Steroid Injection

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2026
Registry last updated
Jun 10, 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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