Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-01-02 @ 12:01 PM
Study NCT ID:
NCT07125768
Status:
COMPLETED
Last Update Posted:
2025-08-15
First Post:
2025-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thermal Radiofrequency Neurolysis Versus Alcoholic Neurolysis of the Genicular Nerves for Treatment of Chronic Knee Pain in Advanced Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-10', 'studyFirstSubmitDate': '2025-08-10', 'studyFirstSubmitQcDate': '2025-08-10', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of knee osteoarthritis pain', 'timeFrame': '6 months post-procedure', 'description': 'Improvement of knee osteoarthritis pain according to Visual Analogue Scale (VAS). VAS: which was a subjective scale used to quantitatively assess pain (0 = No pain, 10 = Severe pain).'}], 'secondaryOutcomes': [{'measure': 'Improvement of quality of life', 'timeFrame': '6 months post-procedure', 'description': 'Improvement of quality of life according to Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. WOMAC is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscale areas: Each scale uses the following descriptors for all items: none, mild moderate, severe, and extreme. These correspond to an ordinal scale of 0-4. The scores were summed up for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68.'}, {'measure': 'Decrease of analgesic requirements of pain control after neurolysis.', 'timeFrame': '6 months post-procedure', 'description': 'All patients received standard analgesic regimen in the form of non-steroidal anti-inflammatory drugs (Diclofenac Sodium) until they reach the same satisfactory level of pain control, and we asked the patient to use diary to record the amount of analgesia used during the follow up period.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thermal Radiofrequency Neurolysis', 'Alcoholic Neurolysis', 'Genicular Nerves', 'Treatment', 'Chronic Knee Pain', 'Advanced Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study aimed to compare the strength and duration of pain relief, quality of life and analgesic consumption between patients who undergo conventional thermal radiofrequency vs patients who undergo chemical neurolysis on genicular nerves by alcohol in chronic knee osteoarthritis pain.', 'detailedDescription': 'Knee osteoarthritis is a degenerative joint disease characterized by the degradation of the articular cartilage, with many factors implicated in the disease pathogenesis.\n\nChronic pain of knee osteoarthritis is a common clinical symptom leading to restricted movement, disability, psychological distress, and impaired quality of life.\n\nThe targeted genicular nerves are those that had a close topographic relationship with the bone cortical surfaces, such as the femoral epicondyles (Superior medial \\[SM\\] and Superior lateral \\[SL\\] genicular nerves) and the medial tibial epicondyle (Inferior medial \\[IM\\] genicular nerve).\n\nNerve ablation causes iatrogenic neural degeneration, aiming only for sensory or sympathetic denervation without motor deficits. The nerve ablation methods currently available are performed by either thermal ablation using radiofrequency or chemical ablation using alcohol or phenol.\n\nChemical neurolysis techniques can be an effective method to accomplish a larger, more thorough lesioning than radiofrequency ablation and are capable of covering the anatomical variability of genicular nerves, so ensuring a better success rate and outcome with less cost and less logistic support.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age from 40 to 60 years.\n* Both sexes.\n* Stage 3 and 4 knee osteoarthritis in patients who aren't responding to pharmacological treatment and aren't good candidates for knee replacement surgery.\n\nExclusion Criteria:\n\n* Neurological disorders (Previous cerebrovascular stroke, neuropathy, or weakness).\n* Bleeding disorders.\n* Infection at or near the injection site.\n* Presence of a pacemaker or defibrillator.\n* Acute knee injury.\n* Unstable knee joint."}, 'identificationModule': {'nctId': 'NCT07125768', 'briefTitle': 'Thermal Radiofrequency Neurolysis Versus Alcoholic Neurolysis of the Genicular Nerves for Treatment of Chronic Knee Pain in Advanced Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparative Study Between Thermal Radiofrequency Neurolysis Versus Alcoholic Neurolysis of the Genicular Nerves for Treatment of Chronic Knee Pain in Advanced Knee Osteoarthritis', 'orgStudyIdInfo': {'id': '36264MS603/5/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'Patients received C-arm guided neurolysis of superior medial \\[SM\\], superior lateral \\[SL\\], and inferior medial \\[IM\\] genicular nerves by thermal radiofrequency.', 'interventionNames': ['Other: Thermal Radiofrequency Neurolysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II', 'description': 'Patients received C-arm guided injection of each of the three genicular nerves with 1 ml of a solution containing 70% alcohol in 0.25% lidocaine.', 'interventionNames': ['Other: Alcoholic Neurolysis']}], 'interventions': [{'name': 'Thermal Radiofrequency Neurolysis', 'type': 'OTHER', 'description': 'Patients received C-arm guided neurolysis of superior medial \\[SM\\], superior lateral \\[SL\\], and inferior medial \\[IM\\] genicular nerves by thermal radiofrequency.', 'armGroupLabels': ['Group I']}, {'name': 'Alcoholic Neurolysis', 'type': 'OTHER', 'description': 'Patients received C-arm guided injection of each of the three genicular nerves with 1 ml of a solution containing 70% alcohol in 0.25% lidocaine.', 'armGroupLabels': ['Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of the study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of the study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of Anesthesiology, Surgical Intensive Care and Pain Management Department, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Hesham Mahmoud Elsayed Eldamhogy', 'investigatorAffiliation': 'Tanta University'}}}}