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

Completed · Not applicable · Has a placebo group

Conditions studied: Chronic Pain, Low Back Pain, Heat, Analgesia

In brief

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.

Key facts

Study ID

NCT04109703

Run by

Soovu Labs Inc.

People needed

100

Starts

2019-06-01

Expected to finish

2019-09-25

Last updated by the study team

2019-12-30

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Northern California Research Institute — Sacramento, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.