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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Radiculopathy Lumbar, Disc Disease Lumbar

Intervention / Treatment
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* Device: Ultrasound microendoscopic technique
* Radiation: Fluoroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Fluoroscopy<br>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). | Radiation: Fluoroscopy<br>* Fluoroscopy-guided lumbar transforaminal epidural steroid injection.<br>|
| Experimental: Ultrasound Microendoscopic<br>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. | Device: Ultrasound microendoscopic technique<br>* Ultrasound-guided microendoscopic lumbar transforaminal epidural steroid injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural Injections, Lumbar Manipulation, Fluoroscopy, Ultrasound