Status:
COMPLETED
High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain
Lead Sponsor:
Soovu Labs Inc.
Collaborating Sponsors:
Northern California Research Corporation
University of Washington
Conditions:
Chronic Pain
Low Back Pain
Eligibility:
All Genders
21-70 years
Phase:
NA
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 °...
Detailed Description
1. 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...
Eligibility Criteria
Inclusion
- 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
- 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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Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04109703
Start Date
June 1 2019
End Date
September 25 2019
Last Update
December 30 2019
Active Locations (1)
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1
Northern California Research Institute
Sacramento, California, United States, 95821