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

American University of Beirut Medical Center

Status: Not yet enrolling

Conditions: Disc Disease Lumbar; Radiculopathy Lumbar

Treatments: Device: Ultrasound microendoscopic technique; Radiation: Fluoroscopy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05729022

BIO-2022-0218

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups, including a placebo group

Fluoroscopy

Placebo Comparator group

Description:

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).

Treatment:

Radiation: Fluoroscopy

Ultrasound Microendoscopic

Experimental group

Description:

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.

Treatment:

Device: Ultrasound microendoscopic technique