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

December 18, 2024 updated by: Damla Yürük

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Damla Yürük, Associate Professor of Algolog
  • Phone Number: +905319932378
  • Email: damlayuruk@hotmail.com

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey, 06010
        • Ankara Etlik City Hospital
        • Contact:
        • Contact:
        • Contact:
          • GÖZDE EROL, Algology Subspecialty Fellow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
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.
1 day (during the procedure)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day (during the procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANKARA ETLIK CITY HOSPİTAL (Other Identifier: ANKARA ETLIK CITY HOSPİTAL)
  • 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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