At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain
In Brief
A clinical study evaluating High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc. and Low Level (37 degrees C) delivered by the control device Generation 5 devices from Soovu Labs Inc. for Chronic Pain and 3 related conditions. Completed, enrolled 100 participants across 1 site.
Detailed Summary
This study is a double blinded randomized active placebo controlled trial in subjects with chronic low back pain. The trial compares pain relief by a device that delivered high level pulsed heat (45 °C) to pain relief delivered by a steady heat lower temperature device (37 °C). The hypothesis is that the high temperature pulsed heat device will produce significantly better pain relief as compared to the lower level steady heat device. The secondary hypothesis is that pain relief will occur faster in the high pulsed heat device as compared to the control device.
Study Details
Timeline
Interventions
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.
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.