Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-06

Study Completion Date

2022-05-16

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

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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.

Conditions

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Lumbar Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ultrasound

selective lumbar nerve root steroid injection under ultrasound guidance.

Group Type ACTIVE_COMPARATOR

selective lumbar nerve root injection

Intervention Type PROCEDURE

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

fluoroscopy

selective lumbar nerve root steroid injection under fluoroscopy guidance.

Group Type SHAM_COMPARATOR

selective lumbar nerve root injection

Intervention Type PROCEDURE

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

Interventions

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selective lumbar nerve root injection

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

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No