## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** US vs. FL SNRB injection
#### Organization
**Class:** OTHER
**Full Name:** Minia University
### Status Module
#### Completion Date
**Date:** 2022-05-16

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-09-27

**Type:** ACTUAL

**Last Update Submit Date:** 2022-09-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-04-12

**Type:** ACTUAL

#### Start Date
**Date:** 2021-04-06

**Type:** ACTUAL

**Status Verified Date:** 2022-09

#### Study First Post Date
**Date:** 2022-03-22
**Type:** ACTUAL
**Study First Submit Date:** 2022-02-25
**Study First Submit QC Date:** 2022-03-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Minia University

#### Responsible Party

**Investigator Affiliation:** Minia University

**Investigator Full Name:** Islam Ahmed Bakr Mohammed

**Investigator Title:** Director

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Lumbar Radiculopathy

**Keywords:**

- lumbar radicular pain

- selective nerve root injection

- ultrasound selective lumbar nerve root injection

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 74

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** selective lumbar nerve root steroid injection under ultrasound guidance.

**Intervention Names:**

- Procedure: selective lumbar nerve root injection

**Label:** ultrasound

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** selective lumbar nerve root steroid injection under fluoroscopy guidance.

**Intervention Names:**

- Procedure: selective lumbar nerve root injection

**Label:** fluoroscopy

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- fluoroscopy

- ultrasound

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

**Name:** selective lumbar nerve root injection

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** improvement of visual analogue score of pain

**Time Frame:** 3 months

**Description:** evaluation of pain relief using Oswestry disability index score on a scale from 0% to 100% with the higher scores mean worse outcome.

**Measure:** improvement of Oswestry disability index score for back pain

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** comparing rate of complications

**Measure:** safety of technique

**Time Frame:** 3 months

**Description:** time of x-ray radiation exposure during procedure.

**Measure:** radiation exposure

**Time Frame:** 1 hour

### Eligibility Module

**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.

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Minya

**Country:** Egypt

**Facility:** Faculty of medicine

**Zip:** 61111

#### Overall Officials

**Official 1:**

**Affiliation:** Professor of Anesthesia and intensive care, MiniaU.

**Name:** Amany K Abu Elhusein, PhD

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Assistant professor of Anesthesia and intensive care, AsuitU..

**Name:** Abd ELraheem M Mohamed, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010523

- Term: Peripheral Nervous System Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M14689

- Name: Radiculopathy

- Relevance: HIGH

- As Found: Radiculopathy

- ID: M13432

- Name: Peripheral Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011843

- Term: Radiculopathy

### Misc Info Module

- Version Holder: 2024-05-24
