Reliability of MRI and Ultrasound in Cervical Epidural Needle Depth Estimation

NCT06747663 | Not Yet Recruiting

• 2 other identifiers: Ankara Etlik City HospitalAEŞH-BADEK-2024-1133
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Neck Pain; Radicular Pain; Cervical Epidural Injection

Keywords

Cervical Epidural Steroid Injection; Needle Depth Estimation; Ultrasound Guidance; MRI Guidance; Fluoroscopy; Radiation Exposure; Chronic Pain Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Radiation Exposure During Cervical Epidural Steroid Injections

  1 day (during the procedure)

Study Arms (1)

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

Interventions

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.

Cervical Epidural Injection Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damla Yürük: lead
• Ankara Etlik City Hospital: collaborator

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 22514777 BACKGROUND

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• DAMLA YÜRÜK, Associate Professor of Algolog

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DAMLA YÜRÜK, Associate Professor of Algolog

CONTACT

+905319932378; damlayuruk@hotmail.com

TAYLAN AKKAYA, Professor of Algolog

CONTACT

095319932378; damlayuruk@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Algology

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)