Comparison of Electrotherapies for Chronic Low Back Pain

NACompletedINTERVENTIONAL
Enrollment

113

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

Conditions
Non-specific Chronic Low Back Pain
Interventions
DEVICE

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.

DEVICE

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.

DEVICE

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.

All Listed Sponsors
collaborator

Electronic Waveform Lab, Inc.

INDUSTRY

lead

University of Utah

OTHER

NCT01658735 - Comparison of Electrotherapies for Chronic Low Back Pain | Biotech Hunter | Biotech Hunter