An interventional study of Duotherm VibraCool Back Device in Low Back Pain, Low Back Sprain and Low Back Pain, Recurrent, sponsored by MMJ Labs LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-10-21.
Sponsored by MMJ Labs LLC · Not applicable, Interventional, and Device feasibility
Ten patients with acute or chronic low back pain will be invited to try a multimodal device for 20 minutes. Pain will be recorded prior to and after use, and feedback on the device will be elicited.
To facilitate data collection of a short-term intervention, the investigators chose to enroll patients from a mixed physical therapy/chiropractic practice with demographic and economic diversity in the metro Washington area. The neuromodulatory device will have patient controlled frequencies at 50Hz, 100Hz, and 180Hz attached to a 12 x 22 cm metal plate ergonomically curved to fit the low back. The device will be wearable with a neoprene belt on both sides for patients to adjust pressure. The metal pocket in our device holds a 221g clay pack capable of being frozen to 15F or heated to 110F or patient tolerance, with 30 minute thermal capacity. A convenience sample of 10 patients at the clinic was invited to give feedback on the prototype device after informed consent. Changes suggested were incorporated and after informed consent a second group of ten gave will give feedback with the production-ready device.
Exclusion Criteria:
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.
Device: Duotherm VibraCool Back Device
Low back plate belt with mechanicothermal and pressure intervention options.
Change in Pain: Visual Analog Scale (VAS)
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.
Time frame: Before use of device (baseline) and after use of device approximately 30 minutes - 20 minutes of use, with 10 minutes for evaluation
Participants' Choice in Thermal Options
One of four options: hot, cold, none, both
Time frame: 30 minutes
Would You Recommend
Binary approval or disapproval of device
Time frame: After 30 minutes
Subjective Pain Relief
7-item Likert scale of 1 (much worse) to 7 (much better) pain relief over the time of the study
Time frame: 30 minutes
| Milestone | DuoTherm VibraCool Back Device |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
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.
| units on a scale (centimeters) | DuoTherm VibraCool Back Device |
|---|---|
| Change in Pain: Visual Analog Scale (VAS) | 2.1 ± 1.4 |
One of four options: hot, cold, none, both
| Participants | DuoTherm VibraCool Back Device |
|---|---|
| Hot | 9 |
| Cold | 11 |
| None | 0 |
| Both | 0 |
Binary approval or disapproval of device
| Participants | DuoTherm VibraCool Back Device |
|---|---|
| Approve | 20 |
| Disapprove | 0 |
7-item Likert scale of 1 (much worse) to 7 (much better) pain relief over the time of the study
| score on a scale | DuoTherm VibraCool Back Device |
|---|---|
| Subjective Pain Relief | 5.3 ± 0.98 |
Collected over 4 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DuoTherm VibraCool Back Device | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | DuoTherm VibraCool Back Device |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 19 |
| >=65 years | 1 |
| Age, Continuous(years) | DuoTherm VibraCool Back Device |
|---|---|
| Mean | 41.9 ± 11.0 |
| Sex: Female, Male(Participants) | DuoTherm VibraCool Back Device |
|---|---|
| Female | 11 |
| Male | 9 |
| Ethnicity (NIH/OMB)(Participants) | DuoTherm VibraCool Back Device |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 17 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | DuoTherm VibraCool Back Device |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 18 |
| White | 1 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | DuoTherm VibraCool Back Device |
|---|---|
| United States | 20 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the clinical results reported in any publications, after deidentification, will be available for a period of 36 months after publication to achieve approved aims of any researcher who provides a methodologically sound proposal. Proposals should be directed to info@mmjlabs.com. To gain acccess, data requestors will need to sign a data access agreement.
Supporting information: Study protocol, Csr
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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