The Aim of Study is to Identify the Predictive Factors for the Success of Transforaminal Epidural Injection in Treatment of Patients with Lumbosacral Radiculopathy

NCT06795542 | Enrolling By Invitation Phase 2 DMC

• 1 other identifier: Soh-Med--25-1-05MS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

the aim of the study is to identify predictive factors for the success of transforaminal epidural injection in the treatment of patients with lumbosacral radiculopathy

Conditions

Lumbar Radiculopathy

Keywords

predictive factors; transforaminal; epidural; injection

Outcome Measures

Primary Outcomes (3)

• Transformainal Epidural Injection

  All patients will be followed up in outpatient clinic every 2 weeks for 3months by assessing Visual Analogue Pain Scale (VAS)

  3 months

• Transformainal Epidural Injection

  All patients will be followed up in outpatient clinic every 2 weeks for 3months by assessing -Roland \& Morris Disability Questionnaire

  3 months

• Transformainal Epidural Injection

  All patients will be followed up in outpatient clinic every 2 weeks for 3months by assessing modified oswestry disability index

  3 months

Study Arms (1)

lumbosacral transforaminal epidural injection

EXPERIMENTAL

Transforaminal Epidural Injections using C-arm imaging with or without Fluoroscopic Guidance

Procedure: lumbosacral transforaminal epidural injection at the level of L4-5, L5-S1, or S1 neural foramina

Interventions

lumbosacral transforaminal epidural injection at the level of L4-5, L5-S1, or S1 neural foramina PROCEDURE

The most widely used injection therapy is epidural injection of steroids, by either the interlaminar route or the caudal route. More contentious are transforaminal injections of steroids. These involve the injection of steroids directly and accurately onto the affected spinal nerve, under radiologic guidance. Meanwhile, transforaminal injection of steroids has been shown to be more effective than interlaminar injection of steroids

lumbosacral transforaminal epidural injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 1.Patients who underwent lumbosacral transforaminal epidural injection at the level of L4-5, L5-S1, or S1 neural foramina 2.Patients age 18 to 60 years 3.Patients had been symptomatic longer than 6 Weeks with Leg pain more than back pain with failure conservative treatment.
• Patients had undergone an MRI Lumbosacral imaging scan documenting disc prolapse

You may not qualify if:

• Patients had previous lumbar surgery 2- Patients had a large herniated disc with severe central or foraminal stenosis on magnetic resonance imaging 3- Patients had Scoliosis , spondylolisthesis or malignancy 4- patients with neurological deficit. 5-Patients had a blood coagulation disorder, or had experienced an allergic reaction to local anesthetics or corticosteroids.

Sponsors & Collaborators

• Amr Mohamed Sedik: lead

Study Sites (1)

Neurossurgery Department of Sohag university

Sohag, Sohag Governorate, 11511, Egypt

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Amr Mohamed Sedek Ahmed

Model Details: steroid

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: January 28, 2025
• Study Start: February 1, 2025
• Primary Completion: September 20, 2025
• Study Completion: September 30, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

EG (1)