US vs FL-Guided Lumbar Nerve Root Injections

Condition(s) studied

Investigational drug(s) / intervention(s)

Ultrasound-Guided Selective Lumbar Nerve Root Injection: A 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: A 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.

Study 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

Primary outcome measure(s)

• Change in Visual Analog Scale (VAS) Score — Baseline and 3 months post-procedure
  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.

Trial sites (1)

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