Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:16 AM
Study NCT ID:
NCT07370233
Status:
COMPLETED
Last Update Posted:
2026-01-27
First Post:
2026-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triple Therapy Strategy for Managing Persistent Pain After Spinal Microdiscectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007268', 'term': 'Injections, Epidural'}, {'id': 'D020728', 'term': 'Transurethral Resection of Prostate'}], 'ancestors': [{'id': 'D007278', 'term': 'Injections, Spinal'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011468', 'term': 'Prostatectomy'}, {'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-19', 'studyFirstSubmitDate': '2026-01-19', 'studyFirstSubmitQcDate': '2026-01-19', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Success Rate of Pain and Disability Mitigation', 'timeFrame': '6 months post-intervention', 'description': ': 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.'}], 'primaryOutcomes': [{'measure': 'Change in Pain Intensity (NRS)', 'timeFrame': '6 months post-intervention', 'description': 'Assessment of back and radicular pain using the 10-point Numeric Rating Scale (NRS)(Score on a scale of 0 to 10)'}, {'measure': 'Change in Disability Level (ODI)', 'timeFrame': '6 months post-intervention', 'description': 'Measurement of functional disability using the Oswestry Disability Index (ODI).'}], 'secondaryOutcomes': [{'measure': 'Serum Concentration of Pro-inflammatory Cytokines (TNF-α)', 'timeFrame': '6 months post-intervention', 'description': 'Evaluation of the anti-inflammatory mechanism by measuring serum Tumor Necrosis Factor-alpha levels via ELISA.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Disk Injury']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '23 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with persistent back pain after microdiscectomy (FBSS).\n* Failure of conservative treatment for at least six months.\n* Positive results on a diagnostic lumbar facet nerve block.\n\nExclusion Criteria:\n\n* Spinal instability, fractures, or spondylolisthesis.\n* Severe psychiatric disorders.\n* Baseline ODI score higher than 60%.\n* Opioid users or history of adverse reactions to steroids.'}, 'identificationModule': {'nctId': 'NCT07370233', 'briefTitle': 'Triple Therapy Strategy for Managing Persistent Pain After Spinal Microdiscectomy', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Synchronous Percutaneous Facet Radiofrequency and Spinal Fixation With Epidural Injection Therapy as a Management for Persistent Radicular Pain After Microdiscectomy', 'orgStudyIdInfo': {'id': 'Rc 8-1-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Triple Therapy 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.', 'interventionNames': ['Drug: Epidural Injection', 'Procedure: thermal Radiofrequency Ablation', 'Procedure: Spinal Fixation', 'Diagnostic Test: ELISA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spinal Fixation Only', 'description': 'Patients with failed back surgery syndrome who undergo percutaneous spinal fixation only, using the Sextant system to stabilize the adjoining vertebrae.', 'interventionNames': ['Procedure: Spinal Fixation', 'Diagnostic Test: ELISA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Control', 'description': 'A cross-matched group of healthy volunteers used solely as a baseline reference for serum inflammatory cytokine levels.', 'interventionNames': ['Diagnostic Test: ELISA']}], 'interventions': [{'name': 'Epidural Injection', 'type': 'DRUG', 'description': 'Advanced Touhy needle delivery of 80 mg triamcinolone and 1500 IU hyaluronidase into the epidural space to target inflammation and adhesions', 'armGroupLabels': ['Triple Therapy Group']}, {'name': 'thermal Radiofrequency Ablation', 'type': 'PROCEDURE', 'description': 'Thermal denervation of the medial branch of the facet nerve at 80°C for 120 seconds using an 18-gauge insulated RF needle.', 'armGroupLabels': ['Triple Therapy Group']}, {'name': 'Spinal Fixation', 'type': 'PROCEDURE', 'description': 'Percutaneous insertion of polyaxial screws and pre-contoured rods via the Sextant System to stabilize the affected spinal levels.', 'armGroupLabels': ['Spinal Fixation Only', 'Triple Therapy Group']}, {'name': 'ELISA', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Healthy Control', 'Spinal Fixation Only', 'Triple Therapy Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'Qalyubia Governorate', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Benha University', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'overallOfficials': [{'name': 'Mohamed Shible, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer at Department of Orthopedic Surgery, Faculty of Medicine'}, {'name': 'Adel Samy Elhammady, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer at Department of Orthopedic Surgery, Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medical Biochemistry', 'investigatorFullName': 'Adel Farag Al Kholy', 'investigatorAffiliation': 'Benha University'}}}}