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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 degrees centigrade °C) to pain relief delivered by a steady heat lower temperature device (37 degrees centigrade °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.
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 lower back pain."
2. The study is designed as a randomized double blinded two arm placebo controlled trial.
3. 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 35-36ºC (96.8 ºF). For reference skin temperature is about 33 ºC and room temperature 23 ºC.
4. 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).
5. Subjects will be told the study is examining the pain relieving effectiveness of two different levels of heat.
6. 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.
7. 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.
8. Ages 22 through 70 inclusive.
9. 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.
10. Pre-treatment assessments include, Numeric Pain Scale (static and bending), and a pre-study questionnaire (history, treatment preferences, short form Brief Pain Inventory, and short form Magill), and a timed walking test.
11. Each treatment session lasts approximately 30 minutes with pain assessments throughout using NPS (primary outcome measure). Secondary outcome measures include measures of comfort, willingness to endorse their treatment and a timed walking test including the number of strides.
12. All subjects are followed for a 4 hour post treatment period with intermittent pain assessments (NPS).
13. At the end of the post treatment period, subjects complete a post study usability questionnaire and a blinding questionnaire.
Generation 5 device Soovu Labs Inc.
Northern California Research Institute
Carewave Medical, Inc.
Published on BioPortfolio: 2019-10-04T08:31:37-0400
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