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

Predictive Factors for the Success of Transforaminal Epidural Injection in Lumbosacral Radiculopathy

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Lumbar Radiculopathy
• Intervention / Treatment: Procedure: lumbosacral transforaminal epidural injection at the level of L4-5, L5-S1, or S1 neural foramina

Detailed Description

Lumbar radicular pain (known as sciatica) represents a prevalent medical and socioeconomic problem.

More than half of the patients with sciatica report a decline in their activities of daily living and ability to work.

Mixed Pathologies as foraminal stenosis, spondylolisthesis, and space-occupying lesions in the lumbar spine can cause Sciatica but the most common cause is lumbar disc herniation. (1) Overall, the vast majority of patients with lumbosacral radiculopathy recover with conservative care as trial of bed rest, oral medications, lumbar corsets and physiotherapy. (2) The involvement of inflammation has attracted the use of steroids (corticosteroids) to reduce the inflammation and, thereby, relieve the pain. Injections of steroids, by various routes, have been used as an alternative to surgery, and as an alternative or complement to conservative therapy, for the treatment of lumbar radicular pain. (3) Steroids are believed to have a therapeutic effect due to their anti inflammatory properties.

This belief is supported by evidence from in vitro studies that show that steroids have a role in decreasing inflammatory mediators such as cytokines and chemokines another study suggests that steroids may provide a stabilizing effect on nociceptive signaling in C-fibers and suppression of ectopic neural discharges. (4) 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 (5) Transforaminal epidural injection may be by autologous Platelet Rich Plasma (PRP) as a novel pharmaceutical agent that has strongly emerged in recent years to treat patients of lumbar disc herniation.(6)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 11511
    • Neurossurgery Department of Sohag university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- 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.

4.Patients had undergone an MRI Lumbosacral imaging scan documenting disc prolapse

Exclusion Criteria:

• 1- 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: lumbosacral transforaminal epidural injection; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Amr Mohamed Sedik

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): September 20, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: January 18, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: epidural; predictive factors; injection; transforaminal
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: Soh-Med--25-1-05MS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No