NCT01507818

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Amp Orthopedics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
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\>
DEVICE	Inactive Sham device	The inactive control device (Sham) identical to the Active device with the exception that a PRF signal is not delivered.

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-09-01
• Completion: 2012-10-01
• First posted: 2012-01-11
• Last updated: 2012-07-09

Locations

3 sites across 1 country: United States