- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04109703
High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain
December 6, 2019 updated by: Soovu Labs Inc.
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 Overview
Status
Completed
Conditions
Detailed Description
- This study will be conducted under Good Clinical Practice (GCP) guidelines and suitable for FDA submission in order to obtain claims such as, "provides temporary pain relief for people with chronic lower back pain."
- The study is designed as a randomized double blinded two arm placebo controlled trial.
- The active arm (N=50) receives two active Series 5 heating units (Soovu Labs Inc.) that pulse heat to 45ºC (113ºF). The active Series 5 placebo arm (N=50) gets two identical appearing units (Soovu Labs Inc.) that produce low level of heat at 37ºC (96.8 ºF). For reference skin temperature is about 33 ºC and room temperature 23 ºC.
- The study hypothesis is that in subjects with chronic low back pain, the active heating device group will show a statistical improvement in pain scores as compared to the active placebo group as measured by the primary outcome measure, the Numeric Pain Scale (NPS).
- Subjects will be told the study is examining the pain relieving effectiveness of two different levels of heat.
- Subjects must have chronic low back pain with a pretreatment level of pain 4 or greater on a 0-10 point scale. By definition chronic low back pain is a condition that has been present for at least 6 months and must be present more days than not over the course of a week.
- No use of pain medications during the four hour trial. However, pain medications including schedule IIIs can be taken up to 30 minutes before the start of the trial. Medications permitted during the trial include medications such as tramadol, codeine, NSIADs, gabapentin and acetaminophen. Non-pain medications for medical indications are permitted at any time. Subjects taking schedule II opioids are excluded from the study. Schedule II opioids include oxycodone, hydromorphone, hydrocodone, fentanyl and methadone.
- Ages 22 through 70 inclusive.
- Exclusion criteria- sciatica if present must be rated significantly less than the non -radiating component of the low back pain, pregnancy, skin lesions such as open skin or sores, scar tissue, skins grafts, old burns over the treatment area or neuropathic sensory loss over the treatment site.
- Pre-treatment assessments include, Numeric Pain Scale, and a pre-study questionnaire (history, treatment preferences, short form Brief Pain Inventory, and short form Magill).
- Each treatment session lasts approximately 30 minutes with pain assessments throughout using NPS (primary outcome measure). Secondary outcome measures include measures of comfort and willingness to endorse their treatment.
- All subjects are followed for a 4 hour post treatment period with intermittent pain assessments (NPS).
- At the end of the post treatment period, subjects complete a post study usability questionnaire and a blinding questionnaire.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
-
Sacramento, California, United States, 95821
- Northern California Research Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
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Exclusion Criteria:
- 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.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: High level pulsed heat
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.
|
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.
Other Names:
|
PLACEBO_COMPARATOR: Low level steady heat
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Rating
Time Frame: 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.
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Changes in the Numerical Pain Scale will be compared between baseline and 30 minutes after minutes of treatment.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Relief 30 Minutes After the Intervention
Time Frame: 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.
|
Changes in the Numerical Pain Scale will be compared between baseline and thirty minutes post intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: charles chabal, MD, Soovu Labs Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2019
Primary Completion (ACTUAL)
September 1, 2019
Study Completion (ACTUAL)
September 25, 2019
Study Registration Dates
First Submitted
September 26, 2019
First Submitted That Met QC Criteria
September 27, 2019
First Posted (ACTUAL)
September 30, 2019
Study Record Updates
Last Update Posted (ACTUAL)
December 30, 2019
Last Update Submitted That Met QC Criteria
December 6, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201969K
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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