Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection

Lumbar Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05290779
• Other study ID #: US vs. FL SNRB injection
• Status: Completed
• Phase: N/A
• Start date: April 6, 2021
• Est. completion date: May 16, 2022

Study information

• Verified date: September 2022
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 16, 2022
• Est. primary completion date: April 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Radiculopathy

Intervention

Procedure:
• selective lumbar nerve root injection
selective lumbar nerve root steroid injection for treatment of radicular pain.

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	safety of technique	comparing rate of complications	3 months
Secondary	radiation exposure	time of x-ray radiation exposure during procedure.	1 hour