113
Participants
Start Date
July 31, 2012
Primary Completion Date
October 31, 2013
Study Completion Date
October 31, 2013
H-Wave
Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.
Transcutaneous Electrical Nerve Stimulation (TENS)
Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.
Sham
The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.
Electronic Waveform Lab, Inc.
INDUSTRY
University of Utah
OTHER