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

NCT04109703 | Completed Results DMC

• 1 other identifier: 201969K
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

chronic pain; low back pain; heat; thermal; analgesia

Outcome Measures

Primary Outcomes (1)

• Pain Rating

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

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

Other Outcomes (1)

• Pain Relief 30 Minutes After the Intervention

  Changes in the Numerical Pain Scale will be compared between baseline and thirty minutes post intervention.

Study Arms (2)

High level pulsed heat

ACTIVE COMPARATOR

Subjects randomized to this arm received a generation 5 device (Soovu Labs Inc.) that produced 30 minutes of heat. The heat was delivered as waves peaking at 45° C.

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

Low level steady heat

PLACEBO COMPARATOR

Subjects randomized to this arm received an identical generation 5 device (Soovu Labs Inc.) that produced 30 minutes of heat. The heat was delivered in a steady manner at 37° C.

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

Interventions

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

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.

Also known as: Experimental arm

High level pulsed heat

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

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.

Also known as: Control arm

Low level steady heat

Eligibility Criteria

• Age: 21 Years - 70 Years
• Gender Eligibility Details: any gender eligible
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic low back pain. By definition chronic low back pain is a condition that has been present for at least 6 months on more days than not. If there is a radiating component of the low back pain the radiating component must have a pain rating less than the non-radiating component of the low back pain.
• Subjects must have pretreatment level of pain 4 or greater.
• Ages 22 through 70 inclusive
• Non pain medications are permitted as needed for conditions such as hypertension, diabetes, heart disease etc.
• Medications such as tramadol, codeine, NSIADs, gabapentin and acetaminophen are not permitted during the trial but may be included under the discretion of the study physician.
• Subjects must have a reliable method for clinic contact and follow-up.

You may not qualify if:

• Sciatica or radicular pain without non-radiating low back pain, cancer, radicular pain greater than the non-radiating component of low back pain, pregnancy, skin lesions such as open skin or sores, scar tissue, skins grafts, old burns over the treatment area.
• Medications including oxycodone, hydromorphone, hydrocodone, fentanyl and methadone are excluded from the trial but may be included under the discretion of the study physician. Such decisions will be documented should they occur.

Sponsors & Collaborators

• Soovu Labs Inc.: lead
• Northern California Research Corporation: collaborator
• University of Washington: collaborator

Study Sites (1)

Northern California Research Institute

Sacramento, California, 95821, United States

Location

MeSH Terms

Conditions

Chronic Pain; Low Back Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Charles Chabal, MD
• Organization: Soovu Labs

Chuck@Soovu.com

206-579-4910

Study Officials

• charles chabal, MD

  Soovu Labs Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded with a control condition using a low level heating (37 degree C) device. The active experimental device used heast that intermittently pulsed to 45 degrees C.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double blinded, randomized, active placebo controlled trial

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: June 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 25, 2019
• Last Updated: December 30, 2019
• Results First Posted: December 30, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)