Actively Recruiting
Ultrasound-Guided Versus Fluoroscopy-Guided Selective Lumbar Nerve Root Injections for Lumbosacral Radiculopathy: A Randomized Clinical Trial
Led by Tanta University · Updated on 2026-06-04
64
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults aged 18 to 75 with lumbosacral radiculopathy, a condition causing lower back and leg pain due to irritated spinal nerves. The trial compares ultrasound-guided nerve root injections to the traditional fluoroscopy-guided injections to see if ultrasound can reduce pain and improve daily function as effectively while avoiding radiation exposure. This randomized study aims to assess pain relief, functional recovery, safety, and procedure speed. Participants receive one lumbar nerve root injection containing a steroid and numbing medicine. One group has the injection guided by ultrasound, which uses sound waves to visualize nerves and soft tissues without radiation. The other group receives the injection guided by fluoroscopy, an X-ray technique using contrast dye to confirm needle placement. After the injection, patients rest for 30 to 60 minutes under observation, then follow up at 1 week, 1 month, and 3 months. During the study, participants complete surveys about pain levels and daily activities. Researchers monitor safety for any complications during and after the procedure. The main outcome is the change in pain measured by a visual scale from baseline to 3 months. Additional measurements include short-term pain scores, disability index, procedure times, patient satisfaction, medication use, and any side effects. The total participation lasts about 3 months with several follow-up visits for evaluation.
CONDITIONS
Brief Title
US vs FL-Guided Lumbar Nerve Root Injections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Clinical diagnosis of lumbar radiculopathy with radicular pain, numbness, or weakness in a dermatomal pattern
- MRI-confirmed nerve root compression from disc herniation or foraminal stenosis
- Failure to improve after at least 3 months of conservative medical treatment
- Radiculopathy affecting L4, L5, or combined L5-S1 levels with a reliably targetable symptomatic level
You will not qualify if you...
- Isolated S1 radiculopathy
- Significant spinal deformities including scoliosis over 20 degrees or spondylolisthesis greater than Grade II
- History of prior lumbar spine surgery
- Bleeding disorders with INR greater than 2.5
- Severe uncontrolled diabetes with HbA1c over 8%
- Advanced cardiac, kidney, or liver disease
- Active systemic infection or infection at the injection site
- Known allergies to corticosteroids or local anesthetics
- Progressive neurological deficits or cauda equina syndrome
- Peripheral neuropathies mimicking radiculopathy
- Pregnancy or breastfeeding
- Severe psychiatric illness or cognitive impairment affecting study participation compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a selective lumbar nerve root injection guided by either ultrasound or fluoroscopy to treat lumbosacral radiculopathy. The procedure includes skin sterilization, antibiotic administration, and medication injection. After the injection, participants are monitored for 30 to 60 minutes for any immediate complications and instructed to rest for 48 hours.
1 treatment visit (in-person) and monitoring for 30 to 60 minutes post-procedure
Duration - 3 months
Participants attend follow-up assessments to monitor pain levels, disability, satisfaction, and any adverse events after the injection.
3 visits at 1 week, 1 month, and 3 months post-procedure (in-person or remote assessments)
Trial Site Locations
Total: 1 location
1
Faculty of Medicine, Tanta University.
Tanta, Gharbia Governorate, Egypt, 31527
Actively Recruiting
Research Team
A
Ahmed S Alkotami, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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