Chronic Unilateral Lumbar Radicular Pain

NCT ID: NCT06092749

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-11-30

Brief Summary

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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

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Conditions

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Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Transgrade technique (TG)

Group Type ACTIVE_COMPARATOR

Transgrade technique (TG)

Intervention Type OTHER

Transgrade (TG) Epidural Steroid Injection technique

Interlaminar technique (IL)

Group Type ACTIVE_COMPARATOR

Interlaminar technique (IL)

Intervention Type OTHER

Interlaminar (IL) Epidural Steroid Injection technique

Interventions

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Transgrade technique (TG)

Transgrade (TG) Epidural Steroid Injection technique

Intervention Type OTHER

Interlaminar technique (IL)

Interlaminar (IL) Epidural Steroid Injection technique

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ibrahim Mamdouh Esmat

Assistant Professor of Anesthesia, Intensive Care and Pain Management Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain-Shams University Hospitals

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ibrahim Mamdouh Esmat

Role: CONTACT

01001241928

Facility Contacts

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Ibrahim Mamdouh Esmat

Role: primary

Other Identifiers

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FMASU MD 286/ 2023

Identifier Type: -

Identifier Source: org_study_id

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