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

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.

Conditions

• Chronic Pain
• Low Back Pain
• Heat
• Analgesia

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.

Sponsors & Collaborators

• Northern California Research Corporation

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Soovu Labs Inc.

  lead INDUSTRY

Principal Investigators

• charles chabal, MD · Soovu Labs Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-06-01

Primary Completion

2019-09-01

Completion

2019-09-25

Countries

• United States

Study Locations