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Reliability of MRI and Ultrasound in Cervical Epidural Needle Depth Estimation

NCT ID: NCT06747663

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-31

Study Completion Date

2025-07-31

Brief Summary

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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

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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.

Conditions

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Chronic Neck Pain Radicular Pain Cervical Epidural Injection

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Needle Depth Measurement Using MRI, Ultrasound, and Fluoroscopy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role collaborator

Damla Yürük

OTHER

Sponsor Role lead

Responsible Party

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Damla Yürük

Associate Professor of Algology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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DAMLA YÜRÜK, Associate Professor of Algolog

Role: PRINCIPAL_INVESTIGATOR

Ankara Etlik City Hospital

Locations

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Ankara Etlik City Hospital

Ankara, Ankara, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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DAMLA YÜRÜK, Associate Professor of Algolog

Role: CONTACT

Phone: +905319932378

Email: [email protected]

TAYLAN AKKAYA, Professor of Algolog

Role: CONTACT

Phone: 095319932378

Email: [email protected]

Facility Contacts

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Damla Yürük, Associate Professor of Algolog

Role: primary

TAYLAN AKKAYA, PROFFESÖR

Role: backup

GÖZDE EROL, Algology Subspecialty Fellow

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 22514777 (View on PubMed)

Other Identifiers

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AEŞH-BADEK-2024-1133

Identifier Type: REGISTRY

Identifier Source: secondary_id

Ankara Etlik City Hospital

Identifier Type: -

Identifier Source: org_study_id