Trial Outcomes & Findings for High Level Pulsed Heat Versus Low Level Steady Heat in Subjects With Chronic Low Back Pain (NCT NCT04109703)
NCT ID: NCT04109703
Last Updated: 2019-12-30
Results Overview
Numerical Pain Score (NPS) Range Zero (minimum) through ten (maximum score) thirty minutes after completion of the treatment session.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Changes in the Numerical Pain Scale will be compared between baseline and 30 minutes after minutes of treatment.
Results posted on
2019-12-30
Participant Flow
Participant milestones
| Measure |
High Level Pulsed Heat
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.
Generation 5 device Soovu Labs Inc.: 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 through a phone-based bluetooth connection. The treatment algorithm used for all subjects in this arm pulsed heat to a temperature of 45 degrees C.
|
Low Level Steady Heat
Subjects randomized to this arm received an identical device (Soovu Labs Inc.) that produced 30 minutes ot heat. The heat was delivered in a steady manner at 37° C.
Generation 5 device Soovu Labs Inc.: 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 through a phone-based bluetooth connection. The treatment algorithm used for all subjects in this arm maintained a steady temperature of 37 degrees C.
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|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
|
Overall Study
COMPLETED
|
49
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High Level Pulsed Heat
n=49 Participants
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.
Generation 5 device Soovu Labs Inc.: 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 through a phone-based bluetooth connection.
|
Low Level Steady Heat
n=51 Participants
Subjects randomized to this arm received an identical device (Soovu Labs Inc.) that produced 30 minutes ot heat. The heat was delivered in a steady manner at 37° C.
Generation 5 device Soovu Labs Inc.: 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 through a phone-based bluetooth connection.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=49 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=100 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=49 Participants
|
48 Participants
n=51 Participants
|
92 Participants
n=100 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=49 Participants
|
3 Participants
n=51 Participants
|
8 Participants
n=100 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=49 Participants
|
34 Participants
n=51 Participants
|
67 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=49 Participants
|
17 Participants
n=51 Participants
|
33 Participants
n=100 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
49 participants
n=49 Participants
|
51 participants
n=51 Participants
|
100 participants
n=100 Participants
|
|
Numerical Pain Scale (NPS)
|
5.56 units on a scale
STANDARD_DEVIATION 0.06 • n=49 Participants
|
5.55 units on a scale
STANDARD_DEVIATION 0.07 • n=51 Participants
|
5.55 units on a scale
STANDARD_DEVIATION 0.06 • n=100 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
High Level Pulsed Heat
n=49 Participants
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.
Generation 5 device Soovu Labs Inc.: 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 through a phone-based bluetooth connection.
|
Low Level Steady Heat
n=51 Participants
Subjects randomized to this arm received an identical device (Soovu Labs Inc.) that produced 30 minutes ot heat. The heat was delivered in a steady manner at 37° C.
Generation 5 device Soovu Labs Inc.: 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 through a phone-based bluetooth connection.
|
|---|---|---|
|
Pain Rating
|
-1.40 reduction in pain score on a scale
Standard Error 0.016
|
-0.68 reduction in pain score on a scale
Standard Error 0.019
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Changes in the Numerical Pain Scale will be compared between baseline and thirty minutes post intervention.Population: All subjects with longstanding chronic low back pain median duration 10 years. Subjects who received the high level pulsed heat device with heat pulses up to 45 degrees C. Steady heat subjects received a device that heated to 37 degrees C at a steady level.
Numerical Pain Scale Range Zero (minimum) through ten (maximum score) In this study a lower number on the Numeric Pain Scale means the subject(s) has less pain. Less pain particularly in the experimental group is a better outcome.
Outcome measures
| Measure |
High Level Pulsed Heat
n=49 Participants
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.
Generation 5 device Soovu Labs Inc.: 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 through a phone-based bluetooth connection.
|
Low Level Steady Heat
n=51 Participants
Subjects randomized to this arm received an identical device (Soovu Labs Inc.) that produced 30 minutes ot heat. The heat was delivered in a steady manner at 37° C.
Generation 5 device Soovu Labs Inc.: 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 through a phone-based bluetooth connection.
|
|---|---|---|
|
Pain Relief 30 Minutes After the Intervention
|
-1.40 units on a scale
Standard Error 0.016
|
-0.68 units on a scale
Standard Error 0.019
|
Adverse Events
High Level Pulsed Heat
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Level Steady Heat Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place