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| Name | Class |
|---|---|
| Quantel Medical | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoroscopy | Placebo Comparator | A local anesthetic (2% lidocaine), a 22G, 90mm needle (Quincke spinal needle) is inserted into the skin. Once the needle tip is in its target position, 0.5-5 cc of contrast (Omnipauqe) is injected. If the contrast spread along the spinal nerve into the epidural space, a mixture of 3 cc of 0.125% Marcaine and 40 mg of Depo-Medrol is injected or Diprofos (1/2 ampoule (2 ml) per level). |
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| Ultrasound Microendoscopic | Experimental | A US device with a curvilinear probe and with a microendoscope (EvoTouch+7 Star Scope), inserted into an 18G needle is used. This group will also receive one AP view fluoroscopy (as control) to check for the diffusion of the contrast material in the epidural space. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound microendoscopic technique | Device | Ultrasound-guided microendoscopic lumbar transforaminal epidural steroid injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Patient satisfaction towards the procedure is indicated on NRS scale (0-10). | 3 weeks after discharge. |
| NRS pain score | Pain score will be assessed on NRS scale from 0-10. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marwan Rizk, MD | Contact | +9611350000 | 6380 | mr04@aub.edu.lb |
| Thouraya HajAli, MSc | Contact | +9611350000 | 5738 | th64@aub.edu.lb |
| Name | Affiliation | Role |
|---|---|---|
| Marwan Rizk, MD | American University of Beirut Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American University of Beirut Medical Center | Beirut | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16906179 | Background | Manchikanti L. Transforaminal lumbar epidural steroid injections. Pain Physician. 2000 Oct;3(4):374-98. | |
| 32355743 | Background | 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. |
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| ID | Term |
|---|---|
| C535531 | Intervertebral disc disease |
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| Fluoroscopy | Radiation | Fluoroscopy-guided lumbar transforaminal epidural steroid injection. |
|
| Before procedure, 30 minutes after the procedure, 1 week and 3 weeks after the procedure. |
| Complications | Intravascular injection, intraneural injection, subarachnoid injection and patient discomfort. | During procedure. |
| Procedure time | Time taken to complete the procedure. | Beginning of procedure till the end. |
| Ultrasound visibility | Visualization of the radicular artery and visualization of the nerve root (yes/no answer) | During procedure. |
| 28298750 | Background | 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. |
| 31392224 | Background | 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. |
| 22609989 | Background | 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. |
| 24308846 | Background | 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. |
| 25803759 | Background | 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. |