Clinical trial NCT05290779: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Radiculopathy
Keywords: lumbar radicular pain
selective nerve root injection
ultrasound selective lumbar nerve root injection
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: improvement of visual analogue score of pain
timeFrame: 3 months
measure: improvement of Oswestry disability index score for back pain
timeFrame: 3 months
Secondary outcomes:
measure: safety of technique
timeFrame: 3 months
measure: radiation exposure
timeFrame: 1 hour
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of medicine
Study officials:
affiliation: Professor of Anesthesia and intensive care, MiniaU.
name: Amany K Abu Elhusein, PhD
role: STUDY_CHAIR
affiliation: Assistant professor of Anesthesia and intensive care, AsuitU..
name: Abd ELraheem M Mohamed, MD
role: STUDY_DIRECTOR
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