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Clinical Trials/NCT06747663
NCT06747663
Not yet recruiting
Not Applicable

Reliability of MRI and Ultrasound in Predicting Needle Depth During Cervical Epidural Injections: a Methodological Observational Study

Damla Yürük1 site in 1 country90 target enrollmentJanuary 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Neck Pain
Sponsor
Damla Yürük
Enrollment
90
Locations
1
Primary Endpoint
Accuracy of Needle Depth Prediction Using MRI and Ultrasound Compared to Fluoroscopy in Cervical Epidural Steroid Injections
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

This study aims to evaluate the reliability of magnetic resonance imaging (MRI) and ultrasound (USG) in predicting needle depth during cervical epidural injections, compared to fluoroscopy. The goal is to identify alternative imaging methods that reduce radiation exposure while maintaining procedural accuracy and patient safety.

Detailed Description

Cervical epidural steroid injections (CESI) are commonly used to manage chronic neck and radicular pain. Accurate needle placement is critical for the success and safety of the procedure. Fluoroscopy is the standard method for guiding the needle; however, it exposes patients and clinicians to ionizing radiation. This study compares pre-procedural MRI and USG measurements of needle depth with fluoroscopy-guided needle depth during CESI. Primary Objective: Assess the agreement between MRI, USG, and fluoroscopy measurements of needle depth using intraclass correlation coefficients (ICC) within a ±0.3 cm tolerance. Secondary Objectives: Evaluate the correlation between fluoroscopic lateral imaging frequency and radiation exposure. The study is a methodological observational study conducted at Ankara Etlik City Hospital, involving adult patients undergoing CESI. Data will be collected retrospectively and prospectively for eligible participants.

Registry
clinicaltrials.gov
Start Date
January 2025
End Date
July 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Damla Yürük
Responsible Party
Sponsor Investigator
Principal Investigator

Damla Yürük

Associate Professor of Algology

Diskapi Teaching and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years, Diagnosed with chronic cervical pain, Referred for cervical epidural steroid injection, Patients capable of providing informed consent.

Exclusion Criteria

  • Age \< 18 years, Pregnancy or breastfeeding, History of coagulation disorders or use of anticoagulants, Severe systemic infections or local infections at the injection site, Known allergy to steroids or local anesthetics, Uncontrolled diabetes mellitus, Patients with spinal tumors or significant spinal deformities, Previous cervical spine surgery, Cognitive impairment preventing informed consent or follow-up participation.

Outcomes

Primary Outcomes

Accuracy of Needle Depth Prediction Using MRI and Ultrasound Compared to Fluoroscopy in Cervical Epidural Steroid Injections

Time Frame: 1 day (during the procedure)

The primary outcome measure evaluates the reliability and accuracy of pre-procedural needle depth measurements obtained using MRI and ultrasound imaging compared to intra-procedural fluoroscopy during cervical epidural steroid injections. The goal is to determine the concordance between these imaging techniques and assess their utility in reducing procedural radiation exposure.

Secondary Outcomes

  • Radiation Exposure During Cervical Epidural Steroid Injections(1 day (during the procedure))

Study Sites (1)

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