Radiculopathy Lumbar, Disc Disease Lumbar
Conditions
Keywords
Epidural Injections, Lumbar Manipulation, Fluoroscopy, Ultrasound
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.
Interventions
DEVICEUltrasound microendoscopic technique
Ultrasound-guided microendoscopic lumbar transforaminal epidural steroid injection
RADIATIONFluoroscopy
Fluoroscopy-guided lumbar transforaminal epidural steroid injection.
Sponsors
Quantel Medical
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention success rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 3 weeks after discharge. | Patient satisfaction towards the procedure is indicated on NRS scale (0-10). |
| NRS pain score | 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. |
| Complications | During procedure. | Intravascular injection, intraneural injection, subarachnoid injection and patient discomfort. |
| Procedure time | Beginning of procedure till the end. | Time taken to complete the procedure. |
| Ultrasound visibility | During procedure. | Visualization of the radicular artery and visualization of the nerve root (yes/no answer) |
Countries
Lebanon
Contacts
Primary ContactMarwan Rizk, MD
Backup ContactThouraya HajAli, MSc
Outcome results
None listed