High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain
CompletedNot applicableNCT04109703
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
- Official title
- High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain
- Conditions
- Interventions
- Device: High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc.
- Device: Low Level (37 degrees C) delivered by the control device Generation 5 devices from Soovu Labs Inc.
- Sponsor
- Soovu Labs Inc.
- Collaborators
- Northern California Research Corporation; University of Washington
- Start date
- 2019-06-01
- Primary completion
- 2019-09-01
- Sex
- All
- Age range
- from 21 Years to 70 Years
- Healthy volunteers
- true
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. 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. 2. Subjects must have pretreatment level of pain 4 or greater. 3. Ages 22 through 70 inclusive 4. Non pain medications are permitted as needed for conditions such as hypertension, diabetes, heart disease etc. 5. 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. 6. Subjects must have a reliable method for clinic contact and follow-up. \- Exclusion Criteria: 1. 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. 2. 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. \-
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04109703