Effectiveness of the Ivivi Torino II, Pulsed Radio Frequency Device, on Narcotic Use, Pain and Quality of Life Following Shoulder Arthroscopic Rotator Cuff Repair.
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Average daily narcotic consumption (oxycodone mg) [ Time Frame: week-1 post surgery ] [ Designated as safety issue: No ]Average, daily, patient-reported narcotic consumption (converted to oxycodone equivalents in mg) during Week 1.
- Average daily narcotic consumption (oxycodone mg) [ Time Frame: Weeks 2-6 post surgery ] [ Designated as safety issue: No ]Average, daily, patient-reported narcotic consumption during Weeks 2-6
- Visual Analogue Scale (VAS) pain [ Time Frame: Weeks 2-6 post surgery ] [ Designated as safety issue: No ]Daily VAS pain (daily "current" and "maximum") during Week 1, VAS pain (daily "current" and "maximum") during Weeks 2-6
- Patient-reported general health-related quality of life score (EQ-5D) [ Time Frame: On the last day of Weeks 1-6 ] [ Designated as safety issue: No ]The EQ-5D will be completed by the subject on the last day of each week (Weeks 1-6)
- Adverse Events [ Time Frame: Weeks 1-6 post surgery ] [ Designated as safety issue: Yes ]Adverse events will be recorded daily following randomization and analyzed for confirmation of device safety
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||October 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Ivivi Torino II
Active treatment with Non-thermal Pulsed Radio Frequency device
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>
Sham Comparator: Inactive Sham
Device: Inactive Sham device
The inactive control device (Sham) identical to the Active device with the exception that a PRF signal is not delivered.
|United States, Louisiana|
|Tulane University School of Medicine|
|New Orleans, Louisiana, United States, 70112|
|United States, Mississippi|
|Mississippi sports Medicine and Orthopaedic Center|
|Jackson, Mississippi, United States, 39202|
|United States, New Mexico|
|Taos Orthopaedic Institue|
|Taos, New Mexico, United States, 87571|
|Principal Investigator:||Felix Savoie, M.D.||Tulane University Schol of Medicine|