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

October 5, 2023 updated by: Marwan Rizk, American University of Beirut Medical Center

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Thouraya HajAli, MSc
  • Phone Number: 5738 +9611350000
  • Email: th64@aub.edu.lb

Study Contact Backup

  • Name: Marwan Rizk, MD
  • Phone Number: 6380 +9611350000
  • Email: mr04@aub.edu.lb

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • American University of Beirut Medical Center
        • Contact:
          • Marwan Rizk, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound Microendoscopic
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
Ultrasound-guided microendoscopic lumbar transforaminal epidural steroid injection
Placebo Comparator: 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).
Radiation: Fluoroscopy
Fluoroscopy-guided lumbar transforaminal epidural steroid injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention success rate
Time Frame: 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.
During the procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 3 weeks after discharge.
Patient satisfaction towards the procedure is indicated on NRS scale (0-10).
3 weeks after discharge.
Complications
Time Frame: During procedure.
Intravascular injection, intraneural injection, subarachnoid injection and patient discomfort.
During procedure.
Procedure time
Time Frame: Beginning of procedure till the end.
Time taken to complete the procedure.
Beginning of procedure till the end.
NRS pain score
Time Frame: 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.
Before procedure, 30 minutes after the procedure, 1 week and 3 weeks after the procedure.
Ultrasound visibility
Time Frame: During procedure.
Visualization of the radicular artery and visualization of the nerve root (yes/no answer)
During procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American University of Beirut Medical Center

Collaborators

Quantel Medical

Investigators

  • Principal Investigator: Marwan Rizk, MD, American University of Beirut Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO-2022-0218

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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