High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain
High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain
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.
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 37ºC (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, and a pre-study questionnaire
 (history, treatment preferences, short form Brief Pain Inventory, and short form
 Magill).

 11. 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.

 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.
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.

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 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.

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