NCT07370233

Triple Therapy Strategy for Managing Persistent Pain After Spinal Microdiscectomy

Synchronous Percutaneous Facet Radiofrequency and Spinal Fixation With Epidural Injection Therapy as a Management for Persistent Radicular Pain After Microdiscectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: All
• Age: 23 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This interventional study evaluates a "triple therapy" approach-combining percutaneous spinal fixation, facet radiofrequency ablation, and epidural steroid/hyaluronidase injection-for patients with Failed Back Surgery Syndrome (FBSS). The study compares this combined strategy against spinal fixation alone to determine its effectiveness in reducing chronic radicular pain and disability.

Conditions

• Spinal Disk Injury

Interventions

Type	Name	Description
DRUG	Epidural Injection	Advanced Touhy needle delivery of 80 mg triamcinolone and 1500 IU hyaluronidase into the epidural space to target inflammation and adhesions
PROCEDURE	thermal Radiofrequency Ablation	Thermal denervation of the medial branch of the facet nerve at 80°C for 120 seconds using an 18-gauge insulated RF needle.
PROCEDURE	Spinal Fixation	Percutaneous insertion of polyaxial screws and pre-contoured rods via the Sextant System to stabilize the affected spinal levels.
DIAGNOSTIC_TEST	ELISA	Collection of blood samples (S1 at booking and S2 at 6 months) for ELISA estimation of serum biomarkers including TNF-α, IL-1β, and IL-6.

Timeline

• Start date: 2023-02-20
• Primary completion: 2025-03-22
• Completion: 2025-09-23
• First posted: 2026-01-27
• Last updated: 2026-01-27

Locations

1 site across 1 country: Egypt