Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection

NCT05290779 | Completed

• 1 other identifier: US vs. FL SNRB injection
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Conditions

Lumbar Radiculopathy

Keywords

lumbar radicular pain; selective nerve root injection; ultrasound selective lumbar nerve root injection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• safety of technique

  3 months

• radiation exposure

  1 hour

Study Arms (2)

ultrasound

ACTIVE COMPARATOR

selective lumbar nerve root steroid injection under ultrasound guidance.

Procedure: selective lumbar nerve root injection

fluoroscopy

SHAM COMPARATOR

selective lumbar nerve root steroid injection under fluoroscopy guidance.

Procedure: selective lumbar nerve root injection

Interventions

selective lumbar nerve root injection PROCEDURE

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

fluoroscopy; ultrasound

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Faculty of medicine

Minya, 61111, Egypt

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Amany K Abu Elhusein, PhD

  Professor of Anesthesia and intensive care, MiniaU.

  STUDY CHAIR

• Abd ELraheem M Mohamed, MD

  Assistant professor of Anesthesia and intensive care, AsuitU..

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 22, 2022
• Study Start: April 6, 2021
• Primary Completion: April 12, 2022
• Study Completion: May 16, 2022
• Last Updated: September 27, 2022

Record last verified: 2022-09

Locations

EG (1)