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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple Therapy Group | Active Comparator | 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. |
|
| Spinal Fixation Only | Active Comparator | Patients with failed back surgery syndrome who undergo percutaneous spinal fixation only, using the Sextant system to stabilize the adjoining vertebrae. |
|
| Healthy Control | Active Comparator | A cross-matched group of healthy volunteers used solely as a baseline reference for serum inflammatory cytokine levels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural Injection | Drug | Advanced Touhy needle delivery of 80 mg triamcinolone and 1500 IU hyaluronidase into the epidural space to target inflammation and adhesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 months post-intervention |
| Change in Disability Level (ODI) | Measurement of functional disability using the Oswestry Disability Index (ODI). | 6 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of Pro-inflammatory Cytokines (TNF-α) | Evaluation of the anti-inflammatory mechanism by measuring serum Tumor Necrosis Factor-alpha levels via ELISA. | 6 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months post-intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Shible, MD | Lecturer at Department of Orthopedic Surgery, Faculty of Medicine | Principal Investigator |
| Adel Samy Elhammady, MD | Lecturer at Department of Orthopedic Surgery, Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Benha University | Banhā | Qalyubia Governorate | 13511 | Egypt |
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| ID | Term |
|---|---|
| D007268 | Injections, Epidural |
| D020728 | Transurethral Resection of Prostate |
| ID | Term |
|---|---|
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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| 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. |
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| 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. |
|
| D013812 |
| Therapeutics |
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |