Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection

Not Applicable

Completed

• Conditions: Lumbar Radiculopathy
• Interventions: Procedure: selective lumbar nerve root injection

• Registration Number: NCT05290779
• Lead Sponsor: Minia University

Brief Summary

The study is conducted to compare pain relief, accuracy and safety and radiation exposure of selective lumbar nerve root injection for lumbar radicular pain using ultrasound guidance versus fluoroscopy guidance

Detailed Description

Radicular pain is believed to be induced by irritation or inflammation of a nerve root caused by mechanical pressure or chemical irritation from degeneration herniation or rupture of intervertebral disc .Nerve root steroid injection is the most commonly performed minimally invasive technique for treatment of radicular pain in lumbar spine.The mechanism of action of steroids is to reduce inflammation by reduction in proinflammatory mediators around the nerve root, causing reduction in pain levels . Although Fluoroscopy guided technique is the most widely accepted method in lumbar selective nerve root injection, but recently ultrasound technique has gained acceptance among physicians due its reliability, efficacy, real-time guidance of injection and reduction of radiation exposure. Real-time guidance of injection provided by ultrasonography allows for good identification of the spinous process and adjacent structures such as lamina, zygapophyseal articulations and transverse process allowing for safer and potentially equally effective injection technique. The patients are randomly allocated into two groups; one group will receive injection under fluoroscopy guidance and the other group will receive injection under ultrasound guidance. The two groups are compared in terms of pain relief, accuracy and safety and radiation exposure.

Study Timeline

• Study Start: 2021-04-06
• Study First Submitted: 2022-02-25
• Study First Submitted QC: 2022-03-11
• Study First Posted: 2022-03-22
• Primary Completion: 2022-04-12
• Study Completion: 2022-05-16
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• adult patients aged 18-60 years .
• Both sexes .
• With unilateral chronic lumbar radicular pain for more than 3 months.
• Cooperative and oriented patients.
• All patients are diagnosed by a neurologist for radicular low back pain through clinical presentation, medical examinations, computed tomography (CT), or magnetic resonance imaging (MRI).

Exclusion Criteria

• Uncontrolled diabetes.
• Infection at the site of injection.
• Spine fractures.
• Previous back surgery.
• Progressive neurologic disorders.
• Fever.
• Peripheral neuropathy.
• Presence of motor or sphencteric disturbance.
• Bilateral radicular pain.
• Allergy to substance of injection.
• Patients with body mass index (BMI) more than 35.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultrasound	selective lumbar nerve root injection	selective lumbar nerve root steroid injection under ultrasound guidance.
fluoroscopy	selective lumbar nerve root injection	selective lumbar nerve root steroid injection under fluoroscopy guidance.

Primary Outcome Measures

Name	Time	Method
improvement of visual analogue score of pain	3 months	evaluation of pain relief using visual analogue score on a scale from 0 to 10 with higher scores mean worse outcome
improvement of Oswestry disability index score for back pain	3 months	evaluation of pain relief using Oswestry disability index score on a scale from 0% to 100% with the higher scores mean worse outcome.

Secondary Outcome Measures

Name	Time	Method
safety of technique	3 months	comparing rate of complications
radiation exposure	1 hour	time of x-ray radiation exposure during procedure.

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Minya, Egypt