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

NCT05729022 | Not Yet Recruiting

• 1 other identifier: BIO-2022-0218
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiculopathy Lumbar; Disc Disease Lumbar

Keywords

Epidural Injections; Lumbar Manipulation; Fluoroscopy; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Patient satisfaction

  3 weeks after discharge.

• NRS pain score

  Before procedure, 30 minutes after the procedure, 1 week and 3 weeks after the procedure.

• Complications

  During procedure.

• Procedure time

  Beginning of procedure till the end.

• Ultrasound visibility

  During procedure.

Study Arms (2)

Fluoroscopy

PLACEBO COMPARATOR

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

Ultrasound Microendoscopic

EXPERIMENTAL

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

Interventions

Ultrasound microendoscopic technique DEVICE

Ultrasound-guided microendoscopic lumbar transforaminal epidural steroid injection

Ultrasound Microendoscopic

Fluoroscopy RADIATION

Fluoroscopy-guided lumbar transforaminal epidural steroid injection.

Fluoroscopy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead
• Quantel Medical: collaborator

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

Related Publications (7)

• Manchikanti L. Transforaminal lumbar epidural steroid injections. Pain Physician. 2000 Oct;3(4):374-98.

  PMID: 16906179 BACKGROUND

• Wu A, March L, Zheng X, Huang J, Wang X, Zhao J, Blyth FM, Smith E, Buchbinder R, Hoy D. Global low back pain prevalence and years lived with disability from 1990 to 2017: estimates from the Global Burden of Disease Study 2017. Ann Transl Med. 2020 Mar;8(6):299. doi: 10.21037/atm.2020.02.175.

  PMID: 32355743 BACKGROUND

• 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.

  PMID: 28298750 BACKGROUND

• Hashemi M, Dadkhah P, Taheri M, Haji Seyed Abootorabi SM, Naderi-Nabi B. Ultrasound-Guided Lumbar Transforaminal Epidural Injections; A Single Center Fluoroscopic Validation Study. Bull Emerg Trauma. 2019 Jul;7(3):251-255. doi: 10.29252/beat-070307.

  PMID: 31392224 BACKGROUND

• Jee H, Lee JH, Kim J, Park KD, Lee WY, Park Y. Ultrasound-guided selective nerve root block versus fluoroscopy-guided transforaminal block for the treatment of radicular pain in the lower cervical spine: a randomized, blinded, controlled study. Skeletal Radiol. 2013 Jan;42(1):69-78. doi: 10.1007/s00256-012-1434-1. Epub 2012 May 20.

  PMID: 22609989 BACKGROUND

• 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.

  PMID: 24308846 BACKGROUND

• Yang G, Liu J, Ma L, Cai Z, Meng C, Qi S, Zhou H. Ultrasound-guided Versus Fluoroscopy-controlled Lumbar Transforaminal Epidural Injections: A Prospective Randomized Clinical Trial. Clin J Pain. 2016 Feb;32(2):103-8. doi: 10.1097/AJP.0000000000000237.

  PMID: 25803759 BACKGROUND

MeSH Terms

Conditions

Intervertebral disc disease

Study Officials

• Marwan Rizk, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwan Rizk, MD

CONTACT

+9611350000; mr04@aub.edu.lb

Thouraya HajAli, MSc

CONTACT

+9611350000; th64@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)