Triple Therapy Strategy for Managing Persistent Pain After Spinal Microdiscectomy

January 19, 2026 updated by: Adel Farag Al Kholy, Benha University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qalyubia Governorate
      • Banhā, Qalyubia Governorate, Egypt, 13511
        • Faculty of Medicine, Benha University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with persistent back pain after microdiscectomy (FBSS).
  • Failure of conservative treatment for at least six months.
  • Positive results on a diagnostic lumbar facet nerve block.

Exclusion Criteria:

  • Spinal instability, fractures, or spondylolisthesis.
  • Severe psychiatric disorders.
  • Baseline ODI score higher than 60%.
  • Opioid users or history of adverse reactions to steroids.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Triple Therapy Group
Patients with failed back surgery syndrome who receive a combined intervention consisting of thermal radiofrequency ablation of the medial branch, percutaneous spinal fixation (Sextant system), and an epidural injection of triamcinolone mixed with hyaluronidase.
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.
Active Comparator: Spinal Fixation Only
Patients with failed back surgery syndrome who undergo percutaneous spinal fixation only, using the Sextant system to stabilize the adjoining vertebrae.
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.
Active Comparator: Healthy Control
A cross-matched group of healthy volunteers used solely as a baseline reference for serum inflammatory cytokine 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity (NRS)
Time Frame: 6 months post-intervention
Assessment of back and radicular pain using the 10-point Numeric Rating Scale (NRS)(Score on a scale of 0 to 10)
6 months post-intervention
Change in Disability Level (ODI)
Time Frame: 6 months post-intervention
Measurement of functional disability using the Oswestry Disability Index (ODI).
6 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Concentration of Pro-inflammatory Cytokines (TNF-α)
Time Frame: 6 months post-intervention
Evaluation of the anti-inflammatory mechanism by measuring serum Tumor Necrosis Factor-alpha levels via ELISA.
6 months post-intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate of Pain and Disability Mitigation
Time Frame: 6 months post-intervention
: The percentage of participants achieving a successful treatment outcome at 6 months. Success is defined as an "Excellent" or "Good" grade according to Odom's criteria, indicating significant improvement or minimal persistence of preoperative symptoms.
6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: Mohamed Shible, MD, Lecturer at Department of Orthopedic Surgery, Faculty of Medicine
  • Principal Investigator: Adel Samy Elhammady, MD, Lecturer at Department of Orthopedic Surgery, Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Actual)

March 22, 2025

Study Completion (Actual)

September 23, 2025

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rc 8-1-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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