NCT07370233

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

January 19, 2026

Last Update Submit

January 19, 2026

Conditions

Spinal Disk Injury

Outcome Measures

Primary Outcomes (2)

  • Change in Pain Intensity (NRS)

    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)

    Measurement of functional disability using the Oswestry Disability Index (ODI).

    6 months post-intervention

Secondary Outcomes (1)

  • Serum Concentration of Pro-inflammatory Cytokines (TNF-α)

    6 months post-intervention

Other Outcomes (1)

  • Success Rate of Pain and Disability Mitigation

    6 months post-intervention

Study Arms (3)

Triple Therapy Group

ACTIVE COMPARATOR

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 InjectionProcedure: thermal Radiofrequency AblationProcedure: Spinal FixationDiagnostic Test: ELISA

Spinal Fixation Only

ACTIVE COMPARATOR

Patients with failed back surgery syndrome who undergo percutaneous spinal fixation only, using the Sextant system to stabilize the adjoining vertebrae.

Procedure: Spinal FixationDiagnostic Test: ELISA

Healthy Control

ACTIVE COMPARATOR

A cross-matched group of healthy volunteers used solely as a baseline reference for serum inflammatory cytokine levels.

Diagnostic Test: ELISA

Interventions

Epidural InjectionDRUG

Advanced Touhy needle delivery of 80 mg triamcinolone and 1500 IU hyaluronidase into the epidural space to target inflammation and adhesions

Triple Therapy Group
thermal Radiofrequency AblationPROCEDURE

Thermal denervation of the medial branch of the facet nerve at 80°C for 120 seconds using an 18-gauge insulated RF needle.

Triple Therapy Group
Spinal FixationPROCEDURE

Percutaneous insertion of polyaxial screws and pre-contoured rods via the Sextant System to stabilize the affected spinal levels.

Spinal Fixation OnlyTriple Therapy Group
ELISADIAGNOSTIC_TEST

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.

Healthy ControlSpinal Fixation OnlyTriple Therapy Group

Eligibility Criteria

Age23 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Benha University

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Interventions

Injections, EpiduralTransurethral Resection of Prostate

Intervention Hierarchy (Ancestors)

Injections, SpinalInjectionsDrug Administration RoutesDrug TherapyTherapeuticsProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medical Biochemistry

Study Record Dates

First Submitted

January 19, 2026

First Posted

January 27, 2026

Study Start

February 20, 2023

Primary Completion

March 22, 2025

Study Completion

September 23, 2025

Last Updated

January 27, 2026

Record last verified: 2026-01

Locations

EG(1)