Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-03 @ 1:14 PM
Study NCT ID:
NCT01507818
Status:
TERMINATED
Last Update Posted:
2012-07-09
First Post:
2012-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of the Ivivi Torino II, Pulsed Radio Frequency Device, on Narcotic Use, Pain and Quality of Life Following Shoulder Arthroscopic Rotator Cuff Repair.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-06', 'studyFirstSubmitDate': '2012-01-09', 'studyFirstSubmitQcDate': '2012-01-10', 'lastUpdatePostDateStruct': {'date': '2012-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average daily narcotic consumption (oxycodone mg)', 'timeFrame': 'week-1 post surgery', 'description': 'Average, daily, patient-reported narcotic consumption (converted to oxycodone equivalents in mg) during Week 1.'}], 'secondaryOutcomes': [{'measure': 'Average daily narcotic consumption (oxycodone mg)', 'timeFrame': 'Weeks 2-6 post surgery', 'description': 'Average, daily, patient-reported narcotic consumption during Weeks 2-6'}, {'measure': 'Visual Analogue Scale (VAS) pain', 'timeFrame': 'Weeks 2-6 post surgery', 'description': 'Daily VAS pain (daily "current" and "maximum") during Week 1, VAS pain (daily "current" and "maximum") during Weeks 2-6'}, {'measure': 'Patient-reported general health-related quality of life score (EQ-5D)', 'timeFrame': 'On the last day of Weeks 1-6', 'description': 'The EQ-5D will be completed by the subject on the last day of each week (Weeks 1-6)'}, {'measure': 'Adverse Events', 'timeFrame': 'Weeks 1-6 post surgery', 'description': 'Adverse events will be recorded daily following randomization and analyzed for confirmation of device safety'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arthroscopic Rotator Cuff Repair', 'Electromagnetic field treatment', 'Pulsed Radio Frequency treatment', 'Non-invasive', 'Non-thermal'], 'conditions': ['Rotator Cuff Tear']}, 'descriptionModule': {'briefSummary': 'To determine the effectiveness of non-thermal PRF delivered with the Ivivi Torino II on narcotic use, pain, and health-related quality of life following shoulder arthroscopic rotator cuff surgery comparing: Active treatment versus placebo (Sham).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* MRI diagnosis of rotator cuff tear\n* Persistent symptoms despite a minimum of 6 months of failed non-operative management\n* Scheduled for primary or revision arthroscopic rotator cuff repair (with or without any of the following: debridement, subacromial decompression, distal clavicle resection, treatment of biceps tendon and /or glenoid labrum pathology, release of capsule).\n* Age 40 to 80 years\n* Able to read and complete English-language surveys\n* Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects\n* Willingness and ability to comply with study product and methods\n\nExclusion Criteria:\n\n* Diagnosis of adhesive capsulitis requiring global capsular release, instability, fracture, or arthritis\n* Any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverter-defibrillator)\n* Known narcotic allergy, hepatitis, nephritis, or gastrointestinal ulcer\n* Chronic narcotic pain medication dependency\n* Vulnerable populations including prisoners, pregnant women, nursing home residents, the Investigator's students and employees, employees of sponsor, those unable to consent for themselves, uninsured subjects or others who could be subject coercion\n* Worker's compensation claimant\n* Medical condition, in the judgement of the patient's physician, which may interfere with the shoulder surgery or the effectiveness or safety of the study treatment\n* Use of oral prednisone in the past 30 days\n* Use of any investigational drug or participation in another research study within the past 30 days\n* Self-reported diagnosis of autoimmune or inflammatory arthritis (e.g. Rheumatoid Arthritis, Lupus, ets.)"}, 'identificationModule': {'nctId': 'NCT01507818', 'briefTitle': 'Effectiveness of the Ivivi Torino II, Pulsed Radio Frequency Device, on Narcotic Use, Pain and Quality of Life Following Shoulder Arthroscopic Rotator Cuff Repair.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amp Orthopedics, Inc.'}, 'officialTitle': 'Impact of Non-thermal Pulsed Radio Frequency (PRF)on Narcotic Use, Pain, and Health-related Quality of Life Following Shoulder Arthroscopic Rotator Cuff Repair: A Double-Blind, Randomized Sham-Controlled Trial', 'orgStudyIdInfo': {'id': 'Amp-PostOpShoulder-Pain-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ivivi Torino II', 'description': 'Active treatment with Non-thermal Pulsed Radio Frequency device', 'interventionNames': ['Device: Ivivi Torino II']}, {'type': 'SHAM_COMPARATOR', 'label': 'Inactive Sham', 'description': 'Sham treatment', 'interventionNames': ['Device: Inactive Sham device']}], 'interventions': [{'name': 'Ivivi Torino II', 'type': 'DEVICE', 'description': 'Emits a PRF generated specific electromagnetic signal consisting of a 27.12 MHz radio frequency carrier pulse-modulated with a burst duration of 3 milliseconds repeating at 2 times per second (2Hza0\\>', 'armGroupLabels': ['Ivivi Torino II']}, {'name': 'Inactive Sham device', 'type': 'DEVICE', 'description': 'The inactive control device (Sham) identical to the Active device with the exception that a PRF signal is not delivered.', 'armGroupLabels': ['Inactive Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University School of Medicine', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '39202', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Mississippi sports Medicine and Orthopaedic Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '87571', 'city': 'Taos', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Taos Orthopaedic Institue', 'geoPoint': {'lat': 36.40725, 'lon': -105.57307}}], 'overallOfficials': [{'name': 'Felix Savoie, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tulane University Schol of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amp Orthopedics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}