Effectiveness of the Ivivi Torino II, Pulsed Radio Frequency Device, on Narcotic Use, Pain and Quality of Life Following Shoulder Arthroscopic Rotator Cuff Repair.

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Device: Ivivi Torino II
* Device: Inactive Sham device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ivivi Torino II<br>Active treatment with Non-thermal Pulsed Radio Frequency device | Device: Ivivi Torino II<br>* 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><br>|
| Sham Comparator: Inactive Sham<br>Sham treatment | Device: Inactive Sham device<br>* The inactive control device (Sham) identical to the Active device with the exception that a PRF signal is not delivered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average daily narcotic consumption (oxycodone mg) | Average, daily, patient-reported narcotic consumption (converted to oxycodone equivalents in mg) during Week 1. | week-1 post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average daily narcotic consumption (oxycodone mg) | Average, daily, patient-reported narcotic consumption during Weeks 2-6 | Weeks 2-6 post surgery | 
| Visual Analogue Scale (VAS) pain | Daily VAS pain (daily current and maximum) during Week 1, VAS pain (daily current and maximum) during Weeks 2-6 | Weeks 2-6 post surgery | 
| Patient-reported general health-related quality of life score (EQ-5D) | The EQ-5D will be completed by the subject on the last day of each week (Weeks 1-6) | On the last day of Weeks 1-6 | 
| Adverse Events | Adverse events will be recorded daily following randomization and analyzed for confirmation of device safety | Weeks 1-6 post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroscopic Rotator Cuff Repair, Electromagnetic field treatment, Pulsed Radio Frequency treatment, Non-invasive, Non-thermal