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NCT Number: NCT07370233

Triple Therapy Strategy for Managing Persistent Pain After Spinal 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.

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Key information

Conditions

Spinal Disk Injury

Age range

23 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine, Benha University

Banhā, Qalyubia Governorate, 13511, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epidural Injection

Drug

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

thermal Radiofrequency Ablation

Procedure

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

Spinal Fixation

Procedure

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

ELISA

Diagnostic 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.

Primary outcomes

  1. 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)

  2. Change in Disability Level (ODI)

    Time frame: 6 months post-intervention

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

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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