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Recruiting
NCT07627308
US vs FL-Guided Lumbar Nerve Root Injections
Conditions: Lumbosacral Radiculopathy
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 64
Sponsor: Tanta University
Location: Faculty of Medicine, Tanta University. Tanta Gharbia Governorate
Summary
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
Inclusion Criteria:
* 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.
* Radiculopathy affecting the L4, L5, or combined L5-S1 levels (where the primary symptomatic level can be reliably targeted)
Exclusion Criteria:
* 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).
* Severe uncontrolled diabetes mellitus (HbA1c \>8%).
* Advanced cardiac, renal, or hepatic disease.
* Active systemic infection or localized infection at the injection site.
* Known allergies to corticosteroids or local anesthetics.
* Presence of progressive neurological deficits or cauda equina syndrome.
* Peripheral neuropathies mimicking radiculopathy.
* Pregnancy or breastfeeding.
* Severe psychiatric illness or cognitive impairment affecting study compliance.
Source: ClinicalTrials.gov (NCT07627308). StuddyBuddy aggregates publicly available trial information.