US vs FL-Guided Lumbar Nerve Root Injections
ConditionLumbosacral Radiculopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTanta University
About this trial
The goal of this clinical trial is to learn if ultrasound-guided nerve root injections work as well as fluoroscopy (X-ray)-guided injections to treat lower back and leg pain caused by irritated nerves (lumbosacral radiculopathy) in adults aged 18 to 75 years old.
The main questions it aims to answer are:
* Does ultrasound guidance lower pain as effectively as fluoroscopy guidance after 3 months? * Does one method help participants recover their ability to do daily activities better than the other? * Are ultrasound-guided injections as fast and safe for participants as fluoroscopy-guided injections? Researchers will compare ultrasound-guided nerve root injections to fluoroscopy-guided nerve root injections to see if ultrasound works to treat the pain just as well while allowing participants to avoid radiation exposure.
Participants will:
* Receive one targeted nerve injection of medication (a steroid and numbing medicine) in their lower back using either ultrasound or fluoroscopy to guide the needle. * Stay at the clinic for 30 to 60 minutes after the procedure so researchers can check their safety. * Attend checkups at 1 week, 1 month, and 3 months to answer survey questions about their pain levels and daily functioning.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 75 years.
Clinical diagnosis of lumbar radiculopathy characterized by radicular pain, paresthesia, or weakness in a dermatomal distribution.
Magnetic Resonance Imaging (MRI)-confirmed nerve root compression due to disc herniation or foraminal stenosis.
Failure to respond to at least 3 months of conservative medical treatment.
Disqualifiers
Isolated S1 radiculopathy.
Significant spinal deformities, including scoliosis >20° or spondylolisthesis >Grade II.
History of prior lumbar spine surgery.
Bleeding disorders (International Normalized Ratio [INR] >2.5).
Trial design
Design model
Parallel
Treatments tested in this trial
Ultrasound-Guided Selective Lumbar Nerve Root Injection
Procedure/SurgeryA posterior paravertebral ultrasound scan is performed using a curved transducer, followed by a transverse sonogram at the target site to identify the spinous process, vertebral lamina, facet joints, and intervertebral foramen. A 22-gauge spinal needle is advanced using an in-plane technique until mild paresthesia in the affected dermatome is elicited. The standardized therapeutic medication is then injected without the use of a contrast agent.
Fluoroscopy-Guided Selective Lumbar Nerve Root Injection
Procedure/SurgeryA C-arm fluoroscopy unit is used for visualization. A 22-gauge spinal needle is inserted into the safe triangle near the nerve root under fluoroscopic guidance. Iodinated contrast material (iohexol 240 mgI/mL, 1-2 mL) is injected to confirm extra-vasculature, extra-thecal needle placement and to rule out intravascular injection before the standardized therapeutic medication is administered.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Ultrasound-Guided InjectionExperimental treatment 1 intervention
Group B: Fluoroscopy-Guided InjectionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Visual Analog Scale (VAS) Score
The Visual Analog Scale (VAS) is used to evaluate the intensity of radicular pain. It is a 10-cm horizontal line anchored at 0 representing "no pain" and 10 representing the "worst possible pain." Higher scores indicate greater pain intensity. This outcome reports the change in pain intensity from baseline to the 3-month follow-up.
Time frame
Baseline and 3 months post-procedureSecondary outcomes
1
Visual Analog Scale (VAS) Score at Short-Term Follow-up
The Visual Analog Scale (VAS) evaluates the intensity of radicular pain. It is a 10-cm scale where the minimum value is 0 ("no pain") and the maximum value is 10 ("worst possible pain"). Higher scores indicate greater pain intensity and a worse outcome.
Time frame
1 week and 1 month post-procedure2
Oswestry Disability Index (ODI) Score
The ODI is a questionnaire used to measure a patient's permanent functional disability. Scores range from a minimum of 0% to a maximum of 100%. Higher scores indicate greater disability and a worse outcome.
Time frame
1 week, 1 month, and 3 months post-procedure3
Total Procedural Time
The total time required to perform the injection procedure, measured in minutes from the start of skin preparation to the moment of needle withdrawal.
Time frame
Intraoperative (Day 0)4
Needle Adjustment Time
The specific duration of time, measured in minutes, required for adjusting and maneuvering the needle to reach the target site during the procedure.
Time frame
Intraoperative (Day 0)Sponsors and contacts
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Source ClinicalTrials.gov