Effectiveness of the Ivivi Torino II, Pulsed Radio Frequency Device, on Narcotic Use, Pain and Quality of Life Following Shoulder Arthroscopic Rotator Cuff Repair.
- Conditions
- Rotator Cuff Tear
- Interventions
- Device: Ivivi Torino IIDevice: Inactive Sham device
- Registration Number
- NCT01507818
- Lead Sponsor
- Amp Orthopedics, Inc.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 37
- MRI diagnosis of rotator cuff tear
- 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
- Diagnosis of adhesive capsulitis requiring global capsular release, instability, fracture, or arthritis
- 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.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ivivi Torino II Ivivi Torino II Active treatment with Non-thermal Pulsed Radio Frequency device Inactive Sham Inactive Sham device Sham treatment
- Primary Outcome Measures
Name Time Method Average daily narcotic consumption (oxycodone mg) week-1 post surgery Average, daily, patient-reported narcotic consumption (converted to oxycodone equivalents in mg) during Week 1.
- Secondary Outcome Measures
Name Time Method Adverse Events Weeks 1-6 post surgery Adverse events will be recorded daily following randomization and analyzed for confirmation of device safety
Patient-reported general health-related quality of life score (EQ-5D) On the last day of Weeks 1-6 The EQ-5D will be completed by the subject on the last day of each week (Weeks 1-6)
Average daily narcotic consumption (oxycodone mg) Weeks 2-6 post surgery Average, daily, patient-reported narcotic consumption during Weeks 2-6
Visual Analogue Scale (VAS) pain Weeks 2-6 post surgery Daily VAS pain (daily "current" and "maximum") during Week 1, VAS pain (daily "current" and "maximum") during Weeks 2-6
Trial Locations
- Locations (3)
Mississippi sports Medicine and Orthopaedic Center
🇺🇸Jackson, Mississippi, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Taos Orthopaedic Institue
🇺🇸Taos, New Mexico, United States