Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lumbar Radiculopathy

Intervention / Treatment
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* Procedure: selective lumbar nerve root injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ultrasound<br>selective lumbar nerve root steroid injection under ultrasound guidance. | Procedure: selective lumbar nerve root injection<br>* selective lumbar nerve root steroid injection for treatment of radicular pain.<br>|
| Sham Comparator: fluoroscopy<br>selective lumbar nerve root steroid injection under fluoroscopy guidance. | Procedure: selective lumbar nerve root injection<br>* selective lumbar nerve root steroid injection for treatment of radicular pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of technique | comparing rate of complications | 3 months | 
| radiation exposure | time of x-ray radiation exposure during procedure. | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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selective nerve root injection, ultrasound selective lumbar nerve root injection, lumbar radicular pain