Skip to main content
OpenTrials
Completed

NCT Number: NCT05290779

Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine

Minya, 61111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

selective lumbar nerve root injection

Procedure

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

Primary outcomes

  1. improvement of visual analogue score of pain

    Time frame: 3 months

    evaluation of pain relief using visual analogue score on a scale from 0 to 10 with higher scores mean worse outcome

  2. improvement of Oswestry disability index score for back pain

    Time frame: 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 outcomes

  1. safety of technique

    Time frame: 3 months

    comparing rate of complications

  2. radiation exposure

    Time frame: 1 hour

    time of x-ray radiation exposure during procedure.

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2022
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.