Chronic Unilateral Lumbar Radicular Pain

NCT06092749 | Recruiting

• 1 other identifier: FMASU MD 286/ 2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Transgrade technique (TG)

ACTIVE COMPARATOR

Other: Transgrade technique (TG)

Interlaminar technique (IL)

ACTIVE COMPARATOR

Other: Interlaminar technique (IL)

Interventions

Interlaminar technique (IL) OTHER

Interlaminar (IL) Epidural Steroid Injection technique

Interlaminar technique (IL)

Transgrade technique (TG) OTHER

Transgrade (TG) Epidural Steroid Injection technique

Transgrade technique (TG)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain-Shams University Hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ibrahim Mamdouh Esmat

CONTACT

01001241928; ibrahim_mamdouh@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia, Intensive Care and Pain Management Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: November 1, 2023
• Primary Completion: July 31, 2026
• Study Completion: July 31, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)