Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection

• Sponsor: Minia University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05290779
• Collaborator: (none)
• Enrollment: 74
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.8
• Patients Per Site Per Month: 5.8

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Lumbar Radiculopathy	Procedure: selective lumbar nerve root injection	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection for Treatment of Radicular Pain
• Actual Study Start Date: Apr 6, 2021
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ultrasound selective lumbar nerve root steroid injection under ultrasound guidance.	Procedure: selective lumbar nerve root injection; selective lumbar nerve root steroid injection for treatment of radicular pain.
Sham Comparator: fluoroscopy selective lumbar nerve root steroid injection under fluoroscopy guidance.	Procedure: selective lumbar nerve root injection; selective lumbar nerve root steroid injection for treatment of radicular pain.

Outcome Measures

Primary Outcome Measures

1. improvement of visual analogue score of pain [3 months]

   evaluation of pain relief using visual analogue score on a scale from 0 to 10 with higher scores mean worse outcome

2. improvement of Oswestry disability index score for back pain [3 months]

   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

1. safety of technique [3 months]

   comparing rate of complications

2. radiation exposure [1 hour]

   time of x-ray radiation exposure during procedure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine	Minya		Egypt	61111

Sponsors and Collaborators

• Minia University

Investigators

• Study Chair: Amany K Abu Elhusein, PhD, Professor of Anesthesia and intensive care, MiniaU.
• Study Director: Abd ELraheem M Mohamed, MD, Assistant professor of Anesthesia and intensive care, AsuitU..

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Islam Ahmed Bakr Mohammed, Director, Minia University
• ClinicalTrials.gov Identifier: NCT05290779
• Other Study ID Numbers: US vs. FL SNRB injection
• First Posted: Mar 22, 2022
• Last Update Posted: Apr 29, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Islam Ahmed Bakr Mohammed, Director, Minia University: lumbar radicular pain; selective nerve root injection; ultrasound selective lumbar nerve root injection
• Additional relevant MeSH terms: Radiculopathy

Study Results

No Results Posted as of Apr 29, 2022