NCT04109703

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

Completed NA Results posted Last updated 30 December 2019

What this trial tests

NA trial testing High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc. in Chronic Pain in 100 participants. Completed in 25 September 2019.

Timeline

1 June 2019

Primary endpoint
1 September 2019

25 September 2019

Quick facts

Lead sponsor	Soovu Labs Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	100
Start date	1 June 2019
Primary completion	1 September 2019
Estimated completion	25 September 2019
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →
• Low Back Pain — all drugs for Low Back Pain →
• Heat — all drugs for Heat →
• Analgesia — all drugs for Analgesia →

Sponsor

Soovu Labs Inc. — full company profile →

Who can join

Adults 21 to 70, any sex, with Chronic Pain or Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Rating Primary · Changes in the Numerical Pain Scale will be compared between baseline and 30 minutes after minutes of treatment.

Numerical Pain Score (NPS) Range Zero (minimum) through ten (maximum score) thirty minutes after completion of the treatment session.

Group	Value	95% CI
High Level Pulsed Heat	-1.40	± 0.016
Low Level Steady Heat	-0.68	± 0.019

Pain Relief 30 Minutes After the Intervention Secondary · Changes in the Numerical Pain Scale will be compared between baseline and thirty minutes post intervention.

Numerical Pain Scale Range Zero (minimum) through ten (maximum score) In this study a lower number on the Numeric Pain Scale means the subject(s) has less pain. Less pain particularly in the experimental group is a better outcome.

Group	Value	95% CI
High Level Pulsed Heat	-1.40	± 0.016
Steady Heat Group	-0.68	± 0.019

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Properties of Thermal Analgesia in a Human Chronic Low Back Pain Model.
   Chabal C, Dunbar PJ, Painter I, Young D, et al · · 2020 · cited 6× · PMID 32884334 · DOI 10.2147/jpr.s260967