Ultrasound-Guided Microendoscopic Versus Fluoroscopic-Guided Lumbar Transforaminal Epidural Steroid Injections
- Conditions
- Disc Disease LumbarRadiculopathy Lumbar
- Interventions
- Device: Ultrasound microendoscopic techniqueRadiation: Fluoroscopy
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 124
- 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
- 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
- Arm && Interventions
Group Intervention Description Ultrasound Microendoscopic Ultrasound microendoscopic technique 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. Fluoroscopy Fluoroscopy 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).
- 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