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

Soovu Labs

Status: Completed

Conditions: Heat; Chronic Pain; Analgesia; Low Back Pain

Treatments: Device: Low Level (37 degrees C) delivered by the control device Generation 5 devices from Soovu Labs Inc.; Device: High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04109703

201969K

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

High level pulsed heat

Active Comparator group

Description:

Subjects randomized to this arm received a generation 5 device (Soovu Labs Inc.) that produced 30 minutes of heat. The heat was delivered as waves peaking at 45° C.

Treatment:

Device: High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc.

Low level steady heat

Placebo Comparator group

Description:

Subjects randomized to this arm received an identical generation 5 device (Soovu Labs Inc.) that produced 30 minutes of heat. The heat was delivered in a steady manner at 37° C.

Treatment:

Device: Low Level (37 degrees C) delivered by the control device Generation 5 devices from Soovu Labs Inc.