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

NCT ID: NCT05729022

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-12-01

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.

Conditions

Radiculopathy Lumbar; Disc Disease Lumbar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: PLACEBO_COMPARATOR

Fluoroscopy

Intervention Type: RADIATION

Fluoroscopy-guided lumbar transforaminal epidural steroid injection.

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.

Group Type: EXPERIMENTAL

Ultrasound microendoscopic technique

Intervention Type: DEVICE

Ultrasound-guided microendoscopic lumbar transforaminal epidural steroid injection

Interventions

Ultrasound microendoscopic technique

Ultrasound-guided microendoscopic lumbar transforaminal epidural steroid injection

Intervention Type: DEVICE

Fluoroscopy

Fluoroscopy-guided lumbar transforaminal epidural steroid injection.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quantel Medical

INDUSTRY

Sponsor Role: collaborator

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Marwan Rizk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwan Rizk, MD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Locations

American University of Beirut Medical Center

Beirut, , Lebanon

Countries

Lebanon

Central Contacts

Marwan Rizk, MD

Role: CONTACT

mr04@aub.edu.lb

+9611350000 ext. 6380

Thouraya HajAli, MSc

Role: CONTACT

th64@aub.edu.lb

+9611350000 ext. 5738

Facility Contacts

Marwan Rizk, MD

Role: primary

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 22609989 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24308846 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 25803759 (View on PubMed)

Other Identifiers

BIO-2022-0218

Identifier Type: -

Identifier Source: org_study_id