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Chronic Unilateral Lumbar Radicular Pain

Primary Purpose

Neuropathic Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Transgrade technique (TG)
Interlaminar technique (IL)
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ain-Shams University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transgrade technique (TG)

Interlaminar technique (IL)

Arm Description

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

Full Information

First Posted
October 16, 2023
Last Updated
October 20, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT06092749
Brief Title
Chronic Unilateral Lumbar Radicular Pain
Official Title
Effectiveness of Transgrade vs Interlaminar Epidural Steroid Injection for Chronic Unilateral Lumbar Radicular Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transgrade technique (TG)
Arm Type
Active Comparator
Arm Title
Interlaminar technique (IL)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Transgrade technique (TG)
Intervention Description
Transgrade (TG) Epidural Steroid Injection technique
Intervention Type
Other
Intervention Name(s)
Interlaminar technique (IL)
Intervention Description
Interlaminar (IL) Epidural Steroid Injection technique
Primary Outcome Measure Information:
Title
The average numeric rating scale (NRS) pain scores
Description
The numeric rating scale (NRS) is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
Time Frame
at 12 weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahim Mamdouh Esmat
Phone
01001241928
Email
ibrahim_mamdouh@med.asu.edu.eg
Facility Information:
Facility Name
Ain-Shams University Hospitals
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Chronic Unilateral Lumbar Radicular Pain

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