A Phase 2 interventional study of Epidural Injection and thermal Radiofrequency Ablation in Spinal Disk Injury, sponsored by Benha University. Completed at 1 site in Egypt. Open to participants aged 23 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Benha University · Phase 2, Interventional, and Treatment
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.
Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 Injection · Procedure: thermal Radiofrequency Ablation · Procedure: Spinal Fixation · Diagnostic Test: ELISA
Patients with failed back surgery syndrome who undergo percutaneous spinal fixation only, using the Sextant system to stabilize the adjoining vertebrae.
Procedure: Spinal Fixation · Diagnostic Test: ELISA
A cross-matched group of healthy volunteers used solely as a baseline reference for serum inflammatory cytokine levels.
Diagnostic Test: ELISA
Advanced Touhy needle delivery of 80 mg triamcinolone and 1500 IU hyaluronidase into the epidural space to target inflammation and adhesions
Thermal denervation of the medial branch of the facet nerve at 80°C for 120 seconds using an 18-gauge insulated RF needle.
Percutaneous insertion of polyaxial screws and pre-contoured rods via the Sextant System to stabilize the affected spinal levels.
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.
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
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
Success Rate of Pain and Disability Mitigation
: 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.
Time frame: 6 months post-intervention
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Benha University