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Triple Therapy Strategy for Managing Persistent Pain After Spinal Microdiscectomy

NCT07370233 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-01-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Benha University

    lead OTHER

Principal Investigators

  • Mohamed Shible, MD · Lecturer at Department of Orthopedic Surgery, Faculty of Medicine

  • Adel Samy Elhammady, MD · Lecturer at Department of Orthopedic Surgery, Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
23 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-20
Primary Completion
2025-03-22
Completion
2025-09-23

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07370233 on ClinicalTrials.gov