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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
37
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\>
The inactive control device (Sham) identical to the Active device with the exception that a PRF signal is not delivered.
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
Average daily narcotic consumption (oxycodone mg)
Average, daily, patient-reported narcotic consumption (converted to oxycodone equivalents in mg) during Week 1.
Time frame: week-1 post surgery
Average daily narcotic consumption (oxycodone mg)
Average, daily, patient-reported narcotic consumption during Weeks 2-6
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Weeks 1-6 post surgery
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