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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07370233

Enrollment

Registered

2026-01-27

Start date

2023-02-20

Completion date

2025-09-23

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Disk Injury

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.

Interventions

DRUGEpidural Injection

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

PROCEDUREthermal 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.

PROCEDURESpinal Fixation

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

DIAGNOSTIC_TESTELISA

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

23 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Pain Intensity (NRS)	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)
Change in Disability Level (ODI)	6 months post-intervention	Measurement of functional disability using the Oswestry Disability Index (ODI).

Secondary

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

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORMohamed Shible, MD

Lecturer at Department of Orthopedic Surgery, Faculty of Medicine

PRINCIPAL_INVESTIGATORAdel Samy Elhammady, MD