Radiculopathy Lumbar Clinical Trial
Official title:
Ultrasound-Guided Microendoscopic Versus Fluoroscopic-Guided Lumbar Transforaminal Epidural Steroid Injections: A Randomized Controlled Trial
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.
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 |
Country | Name | City | State |
---|---|---|---|
Lebanon | American University of Beirut Medical Center | Beirut |
Lead Sponsor | Collaborator |
---|---|
American University of Beirut Medical Center | Quantel Medical |
Lebanon,
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
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. |
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