US vs FL-Guided Lumbar Nerve Root Injections

NCT07627308 | Recruiting

• 1 other identifier: 36264PR888/10/24
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lumbosacral Radiculopathy

Keywords

Lumbosacral Radiculopathy; Radicular Pain; Ultrasound-Guided; Fluoroscopy-Guided

Outcome Measures

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.

  Baseline and 3 months post-procedure

Secondary Outcomes (7)

• Visual Analog Scale (VAS) Score at Short-Term Follow-up

  1 week and 1 month post-procedure

• Oswestry Disability Index (ODI) Score

  1 week, 1 month, and 3 months post-procedure

• Total Procedural Time

  Intraoperative (Day 0)

• Needle Adjustment Time

  Intraoperative (Day 0)

• Patient Satisfaction Score

  3 months post-procedure

Study Arms (2)

Ultrasound-Guided Injection

EXPERIMENTAL

Participants receive a selective lumbar nerve root injection under real-time ultrasound guidance. The injectate consists of a 3 mL total volume (1 mL dexamethasone 4 mg, 1 mL 2% lidocaine, and 1 mL 0.9% sodium chloride). No contrast agent is used.

Procedure: Ultrasound-Guided Selective Lumbar Nerve Root Injection

Fluoroscopy-Guided Injection

ACTIVE COMPARATOR

Participants receive a selective lumbar nerve root injection under fluoroscopic guidance. Iodinated contrast material is injected to confirm placement, followed by the therapeutic injectate consisting of a 3 mL total volume (1 mL dexamethasone 4 mg, 1 mL 2% lidocaine, and 1 mL 0.9% sodium chloride).

Procedure: Fluoroscopy-Guided Selective Lumbar Nerve Root Injection

Interventions

Ultrasound-Guided Selective Lumbar Nerve Root Injection PROCEDURE

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.

Ultrasound-Guided Injection

Fluoroscopy-Guided Selective Lumbar Nerve Root Injection PROCEDURE

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.

Fluoroscopy-Guided Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine, Tanta University.

Tanta, Gharbia Governorate, 31527, Egypt

RECRUITING

Central Study Contacts

Ahmed S Alkotami, MD

CONTACT

+201008928948; ahmed.sami@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysts were blinded to group allocation until the primary analysis was completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Neurology

Model Details: Participants are randomly assigned in a 1:1 ratio to either the ultrasound-guided or fluoroscopy-guided intervention arm. The randomization utilizes a computer-generated sequence with permuted blocks of varying sizes (4 and 6) to ensure balanced allocation between the two groups.

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 12 months after publication.
• Access Criteria: Available upon reasonable request to the corresponding author.

Locations

EG (1)