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

Radiculopathy Lumbar Clinical Trial

Official title:

Ultrasound-Guided Microendoscopic Versus Fluoroscopic-Guided Lumbar Transforaminal Epidural Steroid Injections: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05729022
• Other study ID #: BIO-2022-0218
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: October 2023
• Source: American University of Beirut Medical Center
• Contact: Marwan Rizk, MD
• Phone: +9611350000
• Email: mr04[@]aub.edu.lb
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Disc Disease Lumbar
• Radiculopathy
• Radiculopathy Lumbar

Intervention

Device:
• Ultrasound microendoscopic technique
Ultrasound-guided microendoscopic lumbar transforaminal epidural steroid injection

Radiation:
• Fluoroscopy
Fluoroscopy-guided lumbar transforaminal epidural steroid injection.

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
American University of Beirut Medical Center	Quantel Medical

Country where clinical trial is conducted

Lebanon, 

References & Publications (7)

Engel A, King W, MacVicar J; Standards Division of the International Spine Intervention Society. The effectiveness and risks of fluoroscopically guided cervical transforaminal injections of steroids: a systematic review with comprehensive analysis of the published data. Pain Med. 2014 Mar;15(3):386-402. doi: 10.1111/pme.12304. Epub 2013 Dec 5. — View Citation

Hashemi M, Dadkhah P, Taheri M, Haji Seyed Abootorabi SM, Naderi-Nabi B. Ultrasound-Guided Lumbar Transforaminal Epidural Injections; A Single Center Fluoroscopic Validation Study. Bull Emerg Trauma. 2019 Jul;7(3):251-255. doi: 10.29252/beat-070307. — View Citation

Jee H, Lee JH, Kim J, Park KD, Lee WY, Park Y. Ultrasound-guided selective nerve root block versus fluoroscopy-guided transforaminal block for the treatment of radicular pain in the lower cervical spine: a randomized, blinded, controlled study. Skeletal Radiol. 2013 Jan;42(1):69-78. doi: 10.1007/s00256-012-1434-1. Epub 2012 May 20. — View Citation

Manchikanti L. Transforaminal lumbar epidural steroid injections. Pain Physician. 2000 Oct;3(4):374-98. — View Citation

Mehta N, Salaria M, Salaria AQ. Comparison of fluoroscopic Guided Transforaminal Epidural Injections of Steroid and Local Anaesthetic with Conservative Management in Patients with Chronic Lumbar Radiculopathies. Anesth Essays Res. 2017 Jan-Mar;11(1):17-22. doi: 10.4103/0259-1162.186868. — View Citation

Wu A, March L, Zheng X, Huang J, Wang X, Zhao J, Blyth FM, Smith E, Buchbinder R, Hoy D. Global low back pain prevalence and years lived with disability from 1990 to 2017: estimates from the Global Burden of Disease Study 2017. Ann Transl Med. 2020 Mar;8(6):299. doi: 10.21037/atm.2020.02.175. — View Citation

Yang G, Liu J, Ma L, Cai Z, Meng C, Qi S, Zhou H. Ultrasound-guided Versus Fluoroscopy-controlled Lumbar Transforaminal Epidural Injections: A Prospective Randomized Clinical Trial. Clin J Pain. 2016 Feb;32(2):103-8. doi: 10.1097/AJP.0000000000000237. — View Citation

Outcome

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