Triple Therapy Strategy for Managing Persistent Pain After Spinal Microdiscectomy

Benha University

Status and phase: Completed; Phase 2

Conditions: Spinal Disk Injury

Treatments: Procedure: thermal Radiofrequency Ablation; Procedure: Spinal Fixation; Drug: Epidural Injection; Diagnostic Test: ELISA

Study type: Interventional

Funder types: Other

Identifiers

NCT07370233

Rc 8-1-2023

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 23 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 3 patient groups

Triple Therapy Group

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: ELISA

Drug: Epidural Injection

Procedure: Spinal Fixation

Procedure: thermal Radiofrequency Ablation

Spinal Fixation Only

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: ELISA

Procedure: Spinal Fixation

Healthy Control

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: ELISA