Reliability of MRI and Ultrasound in Cervical Epidural Needle Depth Estimation

Not yet recruiting

• Conditions: Chronic Neck Pain; Radicular Pain; Cervical Epidural Injection

• Registration Number: NCT06747663
• Lead Sponsor: Damla Yürük

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24
• Study Start: 2025-01
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of Needle Depth Prediction Using MRI and Ultrasound Compared to Fluoroscopy in Cervical Epidural Steroid Injections	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 Outcome Measures

Name	Time	Method
Radiation Exposure During Cervical Epidural Steroid Injections	1 day (during the procedure)	The secondary outcome measure assesses the level of radiation exposure (in mGy) experienced by patients and practitioners during cervical epidural steroid injections when fluoroscopy is used. Comparisons will be made to determine if the use of pre-procedural MRI or ultrasound reduces fluoroscopy duration and radiation exposure.

Trial Locations

Locations (1)

Ankara Etlik City Hospital; 🇹🇷 Ankara, Turkey