Back to resultsUltrasound-Guided Microendoscopic Versus Fluoroscopic-Guided Lumbar Transforaminal Epidural Steroid Injections
Primary Purpose
Radiculopathy Lumbar, Disc Disease Lumbar
Status
Not yet recruiting
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Ultrasound microendoscopic technique
Fluoroscopy
Sponsored by
About this trial
This is an interventional treatment trial for Radiculopathy Lumbar focused on measuring Epidural Injections, Lumbar Manipulation, Fluoroscopy, Ultrasound
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
Sites / Locations
- American University of Beirut Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Fluoroscopy
Ultrasound Microendoscopic
Arm 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).
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Patient satisfaction
Patient satisfaction towards the procedure is indicated on NRS scale (0-10).
NRS pain score
Pain score will be assessed on NRS scale from 0-10.
Complications
Intravascular injection, intraneural injection, subarachnoid injection and patient discomfort.
Procedure time
Time taken to complete the procedure.
Ultrasound visibility
Visualization of the radicular artery and visualization of the nerve root (yes/no answer)
Full Information
NCT ID
NCT05729022
First Posted
February 6, 2023
Last Updated
October 5, 2023
Sponsor
American University of Beirut Medical Center
Collaborators
Quantel Medical
1. Study Identification
Unique Protocol Identification Number
NCT05729022
Brief Title
Ultrasound-Guided Microendoscopic Versus Fluoroscopic-Guided Lumbar Transforaminal Epidural Steroid Injections
Official Title
Ultrasound-Guided Microendoscopic Versus Fluoroscopic-Guided Lumbar Transforaminal Epidural Steroid Injections: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center
Collaborators
Quantel Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy Lumbar, Disc Disease Lumbar
Keywords
Epidural Injections, Lumbar Manipulation, Fluoroscopy, Ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fluoroscopy
Arm Type
Placebo Comparator
Arm 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).
Arm Title
Ultrasound Microendoscopic
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Ultrasound microendoscopic technique
Intervention Description
Ultrasound-guided microendoscopic lumbar transforaminal epidural steroid injection
Intervention Type
Radiation
Intervention Name(s)
Fluoroscopy
Intervention Description
Fluoroscopy-guided lumbar transforaminal epidural steroid injection.
Primary Outcome Measure Information:
Title
Intervention success rate
Description
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.
Time Frame
During the procedure.
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
Patient satisfaction towards the procedure is indicated on NRS scale (0-10).
Time Frame
3 weeks after discharge.
Title
NRS pain score
Description
Pain score will be assessed on NRS scale from 0-10.
Time Frame
Before procedure, 30 minutes after the procedure, 1 week and 3 weeks after the procedure.
Title
Complications
Description
Intravascular injection, intraneural injection, subarachnoid injection and patient discomfort.
Time Frame
During procedure.
Title
Procedure time
Description
Time taken to complete the procedure.
Time Frame
Beginning of procedure till the end.
Title
Ultrasound visibility
Description
Visualization of the radicular artery and visualization of the nerve root (yes/no answer)
Time Frame
During procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marwan Rizk, MD
Phone
+9611350000
Ext
6380
Email
mr04@aub.edu.lb
First Name & Middle Initial & Last Name or Official Title & Degree
Thouraya HajAli, MSc
Phone
+9611350000
Ext
5738
Email
th64@aub.edu.lb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwan Rizk, MD
Organizational Affiliation
American University of Beirut Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University of Beirut Medical Center
City
Beirut
Country
Lebanon
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marwan Rizk, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16906179
Citation
Manchikanti L. Transforaminal lumbar epidural steroid injections. Pain Physician. 2000 Oct;3(4):374-98.
Results Reference
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32355743
Citation
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.
Results Reference
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PubMed Identifier
28298750
Citation
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.
Results Reference
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PubMed Identifier
31392224
Citation
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.
Results Reference
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PubMed Identifier
22609989
Citation
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.
Results Reference
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PubMed Identifier
24308846
Citation
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.
Results Reference
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PubMed Identifier
25803759
Citation
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.
Results Reference
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Ultrasound-Guided Microendoscopic Versus Fluoroscopic-Guided Lumbar Transforaminal Epidural Steroid Injections
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