Chronic Unilateral Lumbar Radicular Pain | NCT06092749

Studies
Chronic Unilateral Lumbar Radicular Pain

NCT06092749

Sponsor

Ain Shams University

Status

Recruiting

Last Update Posted

Jun 15, 2026Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Neuropathic Pain

Interventions

Transgrade technique (TG)
Interlaminar technique (IL)

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2023Actual

Primary Completion Date

Jul 31, 2026Estimated

Completion Date

Jul 31, 2026Estimated

First Submitted Date

Oct 16, 2023

First Submission Date that Met QC Criteria

Oct 16, 2023

First Posted Date

Oct 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2026

Last Update Posted Date

Jun 15, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ibrahim Mamdouh Esmat, Assistant Professor of Anesthesia, Intensive Care and Pain Management Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt., Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transgrade technique (TG)	Active Comparator		Other: Transgrade technique (TG)
Interlaminar technique (IL)	Active Comparator		Other: Interlaminar technique (IL)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transgrade technique (TG)	Other	Transgrade (TG) Epidural Steroid Injection technique	Transgrade technique (TG)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients who experienced successful pain relief at 3 month post-intervention	Number of patients who experienced successful pain relief at 3 month post-intervention, which is defined as ≥ 50% reduction of numeric rating scale (NRS-11) from pre-intervention level.	6 month post intervention (study period)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ibrahim Mamdouh Esmat	Contact	01001241928		ibrahim_mamdouh@med.asu.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain-Shams University Hospitals	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009437	Neuralgia

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided