Reliability of MRI and Ultrasound in Cervical Epidural Needle Depth Estimation (CERV-MRI-USG)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Neck Pain; Radicular Pain; Cervical Epidural Injection
• Intervention / Treatment: Procedure: Needle Depth Measurement Using MRI, Ultrasound, and Fluoroscopy

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 Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Damla Yürük, Associate Professor of Algolog; Phone Number: +905319932378; Email: damlayuruk@hotmail.com
• Study Contact Backup: Name: TAYLAN AKKAYA, Professor of Algolog; Phone Number: 095319932378; Email: damlayuruk@hotmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06010
    • Ankara Etlik City Hospital
    • Contact: Damla Yürük, Associate Professor of Algolog; Phone Number: +905319932378; Email: damlayuruk@hotmail.com
    • Contact: TAYLAN AKKAYA, PROFFESÖR; Phone Number: 095325569847; Email: dr.taylanakkaya@gmail.com
    • Contact: GÖZDE EROL, Algology Subspecialty Fellow

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult patients aged 18 years and older, diagnosed with chronic cervical pain, and referred for cervical epidural steroid injection. Patients must be capable of providing informed consent and participating in follow-up assessments. Individuals with contraindications such as pregnancy, severe systemic infections, coagulopathy, known allergies to steroids or anesthetics, or prior cervical spine surgery are excluded.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Cervical Epidural Injection Group; Participants undergoing cervical epidural injections for chronic neck and radicular pain. Needle depth will be measured pre-procedurally using MRI and ultrasound and compared with fluoroscopy-guided needle placement to assess reliability and radiation exposure.

Procedure: Needle Depth Measurement Using MRI, Ultrasound, and Fluoroscopy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Needle Depth Prediction Using MRI and Ultrasound Compared to Fluoroscopy in Cervical Epidural Steroid Injections	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.	1 day (during the procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Exposure During Cervical Epidural Steroid Injections	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.	1 day (during the procedure)

Collaborators and Investigators

• Sponsor: Damla Yürük
• Collaborators: Ankara Etlik City Hospital
• Investigators: Principal Investigator: DAMLA YÜRÜK, Associate Professor of Algolog, Ankara Etlik City Hospital

Publications and helpful links

General Publications

• Pak MH, Lee WH, Ko YK, So SY, Kim HJ. Ultrasonographic measurement of the ligamentum flavum depth; is it a reliable method to distinguish true and false loss of resistance? Korean J Pain. 2012 Apr;25(2):99-104. doi: 10.3344/kjp.2012.25.2.99. Epub 2012 Apr 4.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Fluoroscopy; Radiation Exposure; Ultrasound Guidance; Chronic Pain Management; Cervical Epidural Steroid Injection; Needle Depth Estimation; MRI Guidance
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: Ankara Etlik City Hospital (Registry Identifier: Sumeyra Doluoglu); AEŞH-BADEK-2024-1133 (Registry Identifier: Ankara City Hospital Ethics Committee AEŞH-BADEK-2024-1133 Approval Date: 27.11.2024)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data (IPD) will not be shared due to concerns regarding patient confidentiality and data privacy regulations. Data sharing is not part of the current study plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No