Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-30 @ 12:14 PM
Study NCT ID:
NCT04940832
Status:
UNKNOWN
Last Update Posted:
2022-05-09
First Post:
2021-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-04', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-06-23', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in chronic knee pain', 'timeFrame': '2nd and 6th week', 'description': 'Measured by the Knee injury and Osteoarthritis Outcome Score; higher scores indicating that the patients experiences more impairment (All items are scored 0-4; for each subscale the scores are transformed to a 0-100 scale; 0 representing extreme knee problems and 100 representing no knee problems).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Pain Chronic']}, 'descriptionModule': {'briefSummary': 'A single blinded randomized controlled trial to compare outcomes of patients with chronic knee pain receiving radiofrequency with or without corticosteroids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women with pain secondary to osteoarthritis of the knee\n* Age of 18 years and up\n* Fits criteria for procedure of genicular nerve block and pulsed radiofrequency neuromodulation\n\nExclusion Criteria:\n\n* Patients who are incapable of judgment and/or to give informed consent\n* Patients who are pregnant\n* Patients who are under 18 years old\n* Patients who have allergies to local anesthetic\n* Patients with platelet dysfunction or bleeding disorders\n* Patients who are currently mentally unstable\n* Patients who have a diagnosis of fibromyalgia'}, 'identificationModule': {'nctId': 'NCT04940832', 'briefTitle': 'Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'A Single Blinded Randomized Controlled Clinical Trial Comparing Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration', 'orgStudyIdInfo': {'id': 'Knee_pain_radiofrequency'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'radiofrequency with corticosteroids', 'description': 'corticosteroids- 80mg depo-medrol Pulsed radiofrequency to 42 derees celsius for 6 minutes', 'interventionNames': ['Device: pulsed radiofrequency modulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'radiofrequency without corticosteroids', 'description': 'Pulsed radiofrequency to 42 derees celsius for 6 minutes', 'interventionNames': ['Device: pulsed radiofrequency modulation']}], 'interventions': [{'name': 'pulsed radiofrequency modulation', 'type': 'DEVICE', 'description': 'a percutaneous needle electrode to apply pulsed RF signals that modulate the activity of sensory nerves. The pulsing of the RF signal permits a maximum temperature to be achieved - usually 42 Celsius. This helps prevent collateral damage from occurring during the procedure and should help reduce procedural complications.', 'armGroupLabels': ['radiofrequency with corticosteroids', 'radiofrequency without corticosteroids']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Litwinsky', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Matthew Medwick, Doctor', 'role': 'CONTACT', 'email': 'matt.medwick@sheba.health.gov.il', 'phone': '03-5303106'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'centralContacts': [{'name': 'Matthew Medwick, Doctor', 'role': 'CONTACT', 'email': 'matt.medwick@sheba.health.gov.il', 'phone': '03-5303106'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor Head of Pain Clinics, Sheba Medical Center', 'investigatorFullName': 'Dr. Itay GoorAryeh', 'investigatorAffiliation': 'Sheba Medical Center'}}}}