Chronic Unilateral Lumbar Radicular Pain

Effectiveness of Transgrade vs Interlaminar Epidural Steroid Injection for Chronic Unilateral Lumbar Radicular Pain

Chronic neuropathic lumbar pain is among one of the most widespread complaints of patients.Many approaches have been attempted to target chronic pain, with varying efficacy and risks. Transgrade (TG) epidural injection is a new technique using a Racz- Coudé needle for epidural access at a "transgrade" angle without requiring any specialized hardware or accessories. Interlaminar (IL) epidural steroid injection (ESI) is one of the procedures that involves the delivery of injectate to the epidural space through directing a needle between the laminae of two adjacent vertebrae.

Study Overview

• Status: Recruiting
• Conditions: Neuropathic Pain
• Intervention / Treatment: Other: Transgrade technique (TG); Other: Interlaminar technique (IL)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ibrahim Mamdouh Esmat; Phone Number: 01001241928; Email: ibrahim_mamdouh@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain-Shams University Hospitals
    • Contact: Ibrahim Mamdouh Esmat; Email: ibrahim_mamdouh@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• > 6-month history of persistent pain in one leg with back pain.
• Capable of giving informed consent.
• Unsatisfactory response to conventional treatments including physical therapy or medications with a numeric rating scale (NRS) ≥ 5.

Exclusion Criteria:

• Previous lumbar spinal surgery.
• Myelopathy.
• Rheumatoid disorders.
• Psychiatric disorders
• Bleeding or coagulation disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transgrade technique (TG)	Other: Transgrade technique (TG); Transgrade (TG) Epidural Steroid Injection technique
Active Comparator: Interlaminar technique (IL)	Other: Interlaminar technique (IL); Interlaminar (IL) Epidural Steroid Injection technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The average numeric rating scale (NRS) pain scores	The numeric rating scale (NRS) is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."	at 12 weeks after intervention

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: FMASU MD 286/ 2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No