Chronic PainNCT04109703
High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain
A study testing High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc. in people with Chronic Pain and Low Back Pain, run by Soovu Labs Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Low Back Pain, Heat
- What is being tested?
- High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 25 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Northern California Research Institute
Sacramento, California, 95821
About this study
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.
Read the detailed description
- 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."
- The study is designed as a randomized double blinded two arm placebo controlled trial.
- 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.
- 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).
- Subjects will be told the study is examining the pain relieving effectiveness of two different levels of heat.
- 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.
- 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.
- Ages 22 through 70 inclusive.
- 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.
- Pre-treatment assessments include, Numeric Pain Scale, and a pre-study questionnaire (history, treatment preferences, short form Brief Pain Inventory, and short form Magill).
- 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.
- All subjects are followed for a 4 hour post treatment period with intermittent pain assessments (NPS).
- At the end of the post treatment period, subjects complete a post study usability questionnaire and a blinding questionnaire.
- Conditions
- Chronic Pain, Low Back Pain, Heat, Analgesia
- Being tested
- 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.
- Keywords
- chronic pain, low back pain, heat, thermal, analgesia
- Medical subject headings
- Chronic Pain, Low Back Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc.Device
Also called Experimental arm
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.
Low Level (37 degrees C) delivered by the control device Generation 5 devices from Soovu Labs Inc.Device
Also called Control arm
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.
| Study group | Role | What they receive |
|---|---|---|
| High level pulsed heat | Active comparator | 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. Receives: Device: High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc. |
| Low level steady heat | Placebo comparator | 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. Receives: Device: Low Level (37 degrees C) delivered by the control device Generation 5 devices from Soovu Labs Inc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Rating
Numerical Pain Score (NPS) Range Zero (minimum) through ten (maximum score) thirty minutes after completion of the treatment session.
Measured: Changes in the Numerical Pain Scale will be compared between baseline and 30 minutes after minutes of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Jun 2019
- Primary completion1 Sep 2019
- Study completion25 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded, randomized, active placebo controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soovu Labs Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northern California Research Corporation, University of Washington
- Responsible party
- Sponsor
- Investigators
- charles chabal, MD, Principal investigator, Soovu Labs Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109703
- Sponsor's protocol ID
- 201969K
- Status last verified
- Nov 2019
- First submitted
- 26 Sep 2019
- Last updated
- 30 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04109703
- Acronym / sponsor ID
- 201969K
- Conditions
- Chronic Pain, Low Back Pain, Heat, Analgesia
- Keywords
- chronic pain, low back pain, heat, thermal, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Soovu Labs Inc.Industry (pharma, biotech, devices)
- Collaborators
- Northern California Research Corporation, University of Washington
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Posted 30 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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."
- The study is designed as a randomized double blinded two arm placebo controlled trial.
- 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.
- 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).
- Subjects will be told the study is examining the pain relieving effectiveness of two different levels of heat.
- 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.
- 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.
- Ages 22 through 70 inclusive.
- 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.
- Pre-treatment assessments include, Numeric Pain Scale, and a pre-study questionnaire (history, treatment preferences, short form Brief Pain Inventory, and short form Magill).
- 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.
- All subjects are followed for a 4 hour post treatment period with intermittent pain assessments (NPS).
- At the end of the post treatment period, subjects complete a post study usability questionnaire and a blinding questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded, randomized, active placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| High level pulsed heat | Active comparator | Device: High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc.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. |
| Low level steady heat | Placebo comparator | Device: Low Level (37 degrees C) delivered by the control device Generation 5 devices from Soovu Labs Inc.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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc.Also: Experimental armThe 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. | Device | High level pulsed heat |
| Low Level (37 degrees C) delivered by the control device Generation 5 devices from Soovu Labs Inc.Also: Control armThe 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. | Device | Low level steady heat |
Primary outcome
Pain Rating
Time frame: Changes in the Numerical Pain Scale will be compared between baseline and 30 minutes after minutes of treatment.
Numerical Pain Score (NPS) Range Zero (minimum) through ten (maximum score) thirty minutes after completion of the treatment session.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
charles chabal, MD principal investigator
Soovu Labs Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc. in people with Chronic Pain and Low Back Pain, run by Soovu Labs Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Rating (time frame: Changes in the Numerical Pain Scale will be compared between baseline and 30 minutes after minutes of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019.