Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection

Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection for Treatment of Radicular Pain

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

Study Overview

• Status: Completed
• Conditions: Lumbar Radiculopathy
• Intervention / Treatment: Procedure: selective lumbar nerve root injection

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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 61111
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ultrasound; selective lumbar nerve root steroid injection under ultrasound guidance.	Procedure: selective lumbar nerve root injection; selective lumbar nerve root steroid injection for treatment of radicular pain.
Sham Comparator: fluoroscopy; selective lumbar nerve root steroid injection under fluoroscopy guidance.	Procedure: selective lumbar nerve root injection; selective lumbar nerve root steroid injection for treatment of radicular pain.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety of technique	comparing rate of complications	3 months
radiation exposure	time of x-ray radiation exposure during procedure.	1 hour

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Study Chair: Amany K Abu Elhusein, PhD, Professor of Anesthesia and intensive care, MiniaU.; Study Director: Abd ELraheem M Mohamed, MD, Assistant professor of Anesthesia and intensive care, AsuitU..

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Actual): April 12, 2022
• Study Completion (Actual): May 16, 2022

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: lumbar radicular pain; selective nerve root injection; ultrasound selective lumbar nerve root injection
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: US vs. FL SNRB injection

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No