Clinical trial NCT06747663: Reliability of MRI and Ultrasound in Cervical Epidural Needle Depth Estimation
Official title: Reliability of MRI and Ultrasound in Predicting Needle Depth During Cervical Epidural Injections: a Methodological Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
Collaborators: name: Ankara Etlik City Hospital
First posted: 2024-12-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of Needle Depth Prediction Using MRI and Ultrasound Compared to Fluoroscopy in Cervical Epidural Steroid Injections
timeFrame: 1 day (during the procedure)
Secondary outcomes:
measure: Radiation Exposure During Cervical Epidural Steroid Injections
timeFrame: 1 day (during the procedure)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
Study officials:
affiliation: Ankara Etlik City Hospital
name: DAMLA YÜRÜK, Associate Professor of Algolog
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.