Ultrasound-Guided Microendoscopic Versus Fluoroscopic-Guided Lumbar Transforaminal Epidural Steroid Injections

Not Applicable

Not yet recruiting

• Conditions: Disc Disease Lumbar; Radiculopathy Lumbar

• Registration Number: NCT05729022
• Lead Sponsor: American University of Beirut Medical Center

Brief Summary

The purpose of this study is to compare the Microendoscopic combined with ultrasound technique to the standard routinely used X-ray guided transforaminal steroid injection technique.

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility. Patients who meet the eligibility criteria will be randomized in a double-blind manner to two groups. Patients assigned to Group A will undergo a fluoroscopy guided procedure while patients in Group B will undergo a microendoscopic combined with ultrasound technique.

Study Timeline

• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21
• Study Start: 2024-12-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Age between 18 and 64 years old of either sex
• Disease status of American Society of Anesthesiologists grades I to II
• Patients presenting with single-level disc disease and radiculopathy (L2-L3; L3-L4; L4-L5) for steroid injection
• Confirmation of herniated disk by CT or MRI
• Able to give informed consent

Exclusion Criteria

• Age under 18 or over 64 years old
• Pregnant women
• Disease status of American Society of Anesthesiologists grades III to IV
• Unable to provide an informed consent
• Radiculopathies at multiple spinal levels
• Non-lumbar herniated discs
• Clinically obvious or known spinal deformity or stenosis
• Previous spine surgery
• Local or systemic infection
• Allergy to steroids, anesthetics, or contrast material
• Uncorrectable coagulopathy and patients on anticoagulation therapy
• Patients who refuse the procedure
• Spine tuberculosis or tumors
• Prior injections within 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intervention success rate	During the procedure.	The success of the procedure would be indicated by a questionnaire (yes/no answer). This includes the success of visualization under ultrasound and the insertion of the needle within the target position.

Secondary Outcome Measures

Name	Time	Method
NRS pain score	Before procedure, 30 minutes after the procedure, 1 week and 3 weeks after the procedure.	Pain score will be assessed on NRS scale from 0-10.
Complications	During procedure.	Intravascular injection, intraneural injection, subarachnoid injection and patient discomfort.
Ultrasound visibility	During procedure.	Visualization of the radicular artery and visualization of the nerve root (yes/no answer)
Patient satisfaction	3 weeks after discharge.	Patient satisfaction towards the procedure is indicated on NRS scale (0-10).
Procedure time	Beginning of procedure till the end.	Time taken to complete the procedure.

Trial Locations

Locations (1)

American University of Beirut Medical Center; 🇱🇧 Beirut, Lebanon