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Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection

M

Minia University

Status

Completed

Conditions

Lumbar Radiculopathy

Treatments

Procedure: selective lumbar nerve root injection

Study type

Interventional

Funder types

Other

Identifiers

NCT05290779
US vs. FL SNRB injection

Details and patient eligibility

About

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

Full 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.

Enrollment

74 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

74 participants in 2 patient groups

ultrasound
Active Comparator group
Description:
selective lumbar nerve root steroid injection under ultrasound guidance.
Treatment:
Procedure: selective lumbar nerve root injection
fluoroscopy
Sham Comparator group
Description:
selective lumbar nerve root steroid injection under fluoroscopy guidance.
Treatment:
Procedure: selective lumbar nerve root injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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