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Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection

Primary Purpose

Lumbar Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
selective lumbar nerve root injection
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Radiculopathy focused on measuring lumbar radicular pain, selective nerve root injection, ultrasound selective lumbar nerve root injection

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

ultrasound

fluoroscopy

Arm Description

selective lumbar nerve root steroid injection under ultrasound guidance.

selective lumbar nerve root steroid injection under fluoroscopy guidance.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

safety of technique
comparing rate of complications
radiation exposure
time of x-ray radiation exposure during procedure.

Full Information

First Posted
February 25, 2022
Last Updated
September 26, 2022
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT05290779
Brief Title
Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection
Official Title
Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection for Treatment of Radicular Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
April 12, 2022 (Actual)
Study Completion Date
May 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy
Keywords
lumbar radicular pain, selective nerve root injection, ultrasound selective lumbar nerve root injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ultrasound
Arm Type
Active Comparator
Arm Description
selective lumbar nerve root steroid injection under ultrasound guidance.
Arm Title
fluoroscopy
Arm Type
Sham Comparator
Arm Description
selective lumbar nerve root steroid injection under fluoroscopy guidance.
Intervention Type
Procedure
Intervention Name(s)
selective lumbar nerve root injection
Intervention Description
selective lumbar nerve root steroid injection for treatment of radicular pain.
Primary Outcome Measure Information:
Title
improvement of visual analogue score of pain
Description
evaluation of pain relief using visual analogue score on a scale from 0 to 10 with higher scores mean worse outcome
Time Frame
3 months
Title
improvement of Oswestry disability index score for back pain
Description
evaluation of pain relief using Oswestry disability index score on a scale from 0% to 100% with the higher scores mean worse outcome.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
safety of technique
Description
comparing rate of complications
Time Frame
3 months
Title
radiation exposure
Description
time of x-ray radiation exposure during procedure.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amany K Abu Elhusein, PhD
Organizational Affiliation
Professor of Anesthesia and intensive care, MiniaU.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Abd ELraheem M Mohamed, MD
Organizational Affiliation
Assistant professor of Anesthesia and intensive care, AsuitU..
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of medicine
City
Minya
ZIP/Postal Code
61111
Country
Egypt

12. IPD Sharing Statement

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Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection

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