Effectiveness of the Ivivi Torino II, Pulsed Radio Frequency Device, on Narcotic Use, Pain and Quality of Life Following Shoulder Arthroscopic Rotator Cuff Repair.
NCT ID: NCT01507818
Last Updated: 2012-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
37 participants
INTERVENTIONAL
2011-12-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ivivi Torino II
Active treatment with Non-thermal Pulsed Radio Frequency device
Ivivi Torino II
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\>
Inactive Sham
Sham treatment
Inactive Sham device
The inactive control device (Sham) identical to the Active device with the exception that a PRF signal is not delivered.
Interventions
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Ivivi Torino II
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\>
Inactive Sham device
The inactive control device (Sham) identical to the Active device with the exception that a PRF signal is not delivered.
Eligibility Criteria
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Inclusion Criteria
* Persistent symptoms despite a minimum of 6 months of failed non-operative management
* 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).
* Age 40 to 80 years
* Able to read and complete English-language surveys
* Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects
* Willingness and ability to comply with study product and methods
Exclusion Criteria
* Any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverter-defibrillator)
* Known narcotic allergy, hepatitis, nephritis, or gastrointestinal ulcer
* Chronic narcotic pain medication dependency
* 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
* Worker's compensation claimant
* 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
* Use of oral prednisone in the past 30 days
* Use of any investigational drug or participation in another research study within the past 30 days
* Self-reported diagnosis of autoimmune or inflammatory arthritis (e.g. Rheumatoid Arthritis, Lupus, ets.)
40 Years
80 Years
ALL
No
Sponsors
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Amp Orthopedics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Felix Savoie, M.D.
Role: PRINCIPAL_INVESTIGATOR
Tulane University Schol of Medicine
Locations
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Tulane University School of Medicine
New Orleans, Louisiana, United States
Mississippi sports Medicine and Orthopaedic Center
Jackson, Mississippi, United States
Taos Orthopaedic Institue
Taos, New Mexico, United States
Countries
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Other Identifiers
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Amp-PostOpShoulder-Pain-001
Identifier Type: -
Identifier Source: org_study_id