High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 1, 2019

Primary Completion Date

September 1, 2019

Study Completion Date

September 25, 2019

Conditions
Chronic PainLow Back PainHeatAnalgesia
Interventions
DEVICE

High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc.

The Soovu Labss Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are through a phone-based bluetooth connection. For this study the treatment algorithm used for subjects in this arm (experimental) used a temperature that was ramped from skin temperature to a peak temperature of 45° C and cycled for 30 minutes.

DEVICE

Low Level (37 degrees C) delivered by the control device Generation 5 devices from Soovu Labs Inc.

The Soovu Labs Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are via a phone-based bluetooth connection. For this control arm of the study the treatment algorithm held a steady temperature of 37 degrees C for a 30 minute period.

Trial Locations (1)

95821

Northern California Research Institute, Sacramento

All Listed Sponsors
lead

Soovu Labs Inc.

INDUSTRY

collaborator

Northern California Research Corporation

OTHER

collaborator

University of Washington

OTHER