Clinical trial NCT05729022: Ultrasound-Guided Microendoscopic Versus Fluoroscopic-Guided Lumbar Transforaminal Epidural Steroid Injections
Official title: Ultrasound-Guided Microendoscopic Versus Fluoroscopic-Guided Lumbar Transforaminal Epidural Steroid Injections: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Radiculopathy Lumbar
Disc Disease Lumbar
Keywords: Epidural Injections
Lumbar Manipulation
Fluoroscopy
Ultrasound
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
Collaborators: name: Quantel Medical
First posted: 2023-02-15
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intervention success rate
timeFrame: During the procedure.
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 3 weeks after discharge.
measure: NRS pain score
timeFrame: Before procedure, 30 minutes after the procedure, 1 week and 3 weeks after the procedure.
measure: Complications
timeFrame: During procedure.
measure: Procedure time
timeFrame: Beginning of procedure till the end.
measure: Ultrasound visibility
timeFrame: During procedure.
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Marwan Rizk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manchikanti L. Transforaminal lumbar epidural steroid injections. Pain Physician. 2000 Oct;3(4):374-98.
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.
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.
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.
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.
citation: 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.
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.