Chronic Unilateral Lumbar Radicular Pain

Sponsor

Ain Shams University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06092749

Collaborator

(none)

Enrollment

Location

Arms

17.9

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neuropathic Pain	Other: Transgrade technique (TG) Other: Interlaminar technique (IL)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2025

Anticipated Study Completion Date :

Apr 30, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain-Shams University Hospitals	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT06092749

Other Study ID Numbers:

FMASU MD 286/ 2023

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neuralgia

Study Results

No Results Posted as of Oct 23, 2023