High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain
Condition: Chronic Pain; Low Back Pain; Heat; Analgesia
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional

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 °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.
    

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 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.
    

Intervention name(s): High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc.; Low Level (37 degrees C) delivered by the control device Generation 5 devices from Soovu Labs Inc.
Intervention type(s): Device; Device
Intervention description(s): The Soovu Labss Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are through a phone-based bluetooth connection. For this study the treatment algorithm used for subjects in this arm (experimental) used a temperature that was ramped from skin temperature to a peak temperature of 45° C and cycled for 30 minutes.; The Soovu Labs Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are via a phone-based bluetooth connection. For this control arm of the study the treatment algorithm held a steady temperature of 37 degrees C for a 30 minute period.
Other intervention name(s): Experimental arm; Control arm
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blinded, randomized, active placebo controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic pain; low back pain; heat; thermal; analgesia