Trial Outcomes & Findings for Usability of a Multimodal External Neuromodulatory Device to Relieve Acute Low Back Pain (NCT NCT04494841)
NCT ID: NCT04494841
Last Updated: 2022-10-21
Results Overview
Difference in 10 cm VAS printed on paper from 0 (no pain) to 10 (most pain) before and after use of the device, higher value indicates a greater pain reduction, 1.8 cm is considered clinically relevant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Before use of device (baseline) and after use of device approximately 30 minutes - 20 minutes of use, with 10 minutes for evaluation
Results posted on
2022-10-21
Participant Flow
Participant milestones
| Measure |
DuoTherm VibraCool Back Device
Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes.
Duotherm VibraCool Back Device: Low back plate belt with mechanicothermal and pressure intervention options.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Usability of a Multimodal External Neuromodulatory Device to Relieve Acute Low Back Pain
Baseline characteristics by cohort
| Measure |
DuoTherm VibraCool Back Device
n=20 Participants
Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes.
Duotherm VibraCool Back Device: Low back plate belt with mechanicothermal and pressure intervention options.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
41.9 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before use of device (baseline) and after use of device approximately 30 minutes - 20 minutes of use, with 10 minutes for evaluationDifference in 10 cm VAS printed on paper from 0 (no pain) to 10 (most pain) before and after use of the device, higher value indicates a greater pain reduction, 1.8 cm is considered clinically relevant.
Outcome measures
| Measure |
DuoTherm VibraCool Back Device
n=20 Participants
Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes.
Duotherm VibraCool Back Device: Low back plate belt with mechanicothermal and pressure intervention options.
|
|---|---|
|
Change in Pain: Visual Analog Scale (VAS)
|
2.1 units on a scale (centimeters)
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: 30 minutesOne of four options: hot, cold, none, both
Outcome measures
| Measure |
DuoTherm VibraCool Back Device
n=20 Participants
Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes.
Duotherm VibraCool Back Device: Low back plate belt with mechanicothermal and pressure intervention options.
|
|---|---|
|
Participants' Choice in Thermal Options
Both
|
0 Participants
|
|
Participants' Choice in Thermal Options
Hot
|
9 Participants
|
|
Participants' Choice in Thermal Options
Cold
|
11 Participants
|
|
Participants' Choice in Thermal Options
None
|
0 Participants
|
PRIMARY outcome
Timeframe: After 30 minutesBinary approval or disapproval of device
Outcome measures
| Measure |
DuoTherm VibraCool Back Device
n=20 Participants
Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes.
Duotherm VibraCool Back Device: Low back plate belt with mechanicothermal and pressure intervention options.
|
|---|---|
|
Would You Recommend
Approve
|
20 Participants
|
|
Would You Recommend
Disapprove
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 minutes7-item Likert scale of 1 (much worse) to 7 (much better) pain relief over the time of the study
Outcome measures
| Measure |
DuoTherm VibraCool Back Device
n=20 Participants
Patients will be offered a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate. They will be able to choose from 8 patterns of vibration with the multiple motors (50, 100, 200Hz), and hot or cold, and will wear the device for 20 minutes.
Duotherm VibraCool Back Device: Low back plate belt with mechanicothermal and pressure intervention options.
|
|---|---|
|
Subjective Pain Relief
|
5.3 score on a scale
Standard Deviation 0.98
|
Adverse Events
DuoTherm VibraCool Back Device
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