Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06747663

Reliability of MRI and Ultrasound in Cervical Epidural Needle Depth Estimation

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Needle Depth Measurement Using MRI, Ultrasound, and Fluoroscopy

Procedure

This intervention involves cervical epidural steroid injection (CESI) for patients with chronic neck and radicular pain. Needle depth is measured pre-procedurally using MRI and ultrasound to predict the ideal needle placement. Fluoroscopy is used during the procedure to confirm and compare these measurements, aiming to evaluate the accuracy of imaging techniques and minimize radiation exposure.

Primary outcomes

  1. 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

  1. Radiation Exposure During Cervical Epidural Steroid Injections

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

DAMLA YÜRÜK, Associate Professor of Algolog

CONTACT

[email protected]

+905319932378

TAYLAN AKKAYA, Professor of Algolog

CONTACT

[email protected]

095319932378

Sponsors and collaborators

Lead sponsor

Damla Yürük

Other

Collaborators

  • Ankara Etlik City Hospital

Registry information

Official study title

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

Acronym: CERV-MRI-USG

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 24, 2024
Registry last updated
Dec 24, 2024

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.

Published trials that share one or more normalized conditions with this study.