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

NCT01507818 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2012-07-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Amp Orthopedics, Inc.

    lead INDUSTRY

Principal Investigators

  • Felix Savoie, M.D. · Tulane University Schol of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-09-30
Completion
2012-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01507818 on ClinicalTrials.gov