Triple Therapy Strategy for Managing Persistent Pain After Spinal Microdiscectomy

Benha University63 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Spinal Disk Injury

Interventions

Epidural InjectionDRUG

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

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.

Spinal FixationPROCEDURE

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

Eligibility

Sex: ALLMin age: 23 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Medicine, Benha University

Banhā, Qalyubia Governorate, Egypt

Outcomes

Primary Outcomes

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)

Time frame: 6 months post-intervention

Change in Disability Level (ODI)

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

Time frame: 6 months post-intervention

Secondary Outcomes

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

Evaluation of the anti-inflammatory mechanism by measuring serum Tumor Necrosis Factor-alpha levels via ELISA.

Time frame: 6 months post-intervention

Data from ClinicalTrials.gov

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