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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →MMJ Labs LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
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, Clinical study report
Time frame: 36 months after publication
Access criteria: researchers providing approved methodologically sound proposals
Ran from Jan 2020 to primary completion in Jan 2021, 12 months.
Results were first posted in Oct 2022, 1 year 9 months after primary completion.
Of 55 industry-sponsored interventional studies with no phase under Low Back Pain, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's 12 months is below that.
Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
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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