An interventional study of Duotherm VibraCool Back Device and TENS 8-channel unit in Acute Low-back Pain, Chronic Low-back Pain and Pain, Intractable, sponsored by MMJ Labs LLC. Completed at 2 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by MMJ Labs LLC · Not applicable, Interventional, and Treatment
Evaluate pain and disability change in Low Back Pain with DuoTherm Compared to Active Control
160 patients with moderate to severe acute or exacerbations of chronic low back pain presenting for chiropractic and rehabilitation care will be randomized to one of two conditions: a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate; or an 8 channel prescription TENS unit. Patients will be prompted by a Qualtrics text link to a secure data recording site collecting pain and medication use.
90 studies on the registry are indexed under Pain, Intractable; 16 are open to participants now.
This study's enrollment of 160 is above the median of 60 across 64 interventional studies indexed under Pain, Intractable.
Browse Pain, Intractable 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.
Inclusion Criteria (same cohort as enrolled with NCT04491175):
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.
A multimodal low back pain relief device incorporating 8 mechanical stimulation patterns of vibration and 5 intensity settings with optional heat, cold, or pressure delivered through a sculpted metal plate attached by a belt and controlled by buttons on the belt. Patients will be instructed to use the device daily for 30 minutes.
Device: Duotherm VibraCool Back Device
LG SMART TENS stimulator is an 8-channel portable electrotherapy device featuring transcutaneous electrical nerve stimulation (TENS) therapeutic device, which is used for pain relief. The stimulator sends a gentle electrical current to underlying nerves and muscle groups via electrodes applied on the skin. The parameters of the device are controlled by buttons on a controller with an adjustable intensity level.
Device: TENS 8-channel unit
Active New multimodal pain device
Also known as: Vibracool plus heat or pressure, Buzzy
LG Smart TENS unit
Change in current pain intensity from initial to final
Self-rated current pain on Numeric Rating Scale with 0 no pain and 10 maximum pain
Time frame: Daily for 30 days, then weekly and monthly until 3 months (acute) or 6 months (chronic)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Response formats for all scales are a 5-point ordinal rating scale of "Not at all," "A little bit," "Somewhat," "Quite a bit," and "Very much," where lower scores are better and higher scores indicate worse pain. The outcomes being addressed are Change in Monthly Pain Interference (8 questions, yielding possible scores of 8 (low) to 40 (highest) normed on a T-Score where 50 is the average in the United States, 40.7 is "no disability", 55 is mild, 57.7 is moderate, and 65.7 is severe
Time frame: Baseline then weekly and monthly until 3 months (acute) or 6 months (chronic)
Resolution of disability using PROMIS Pain Interference
Achievement of average pain interference of a T-Score of 50 at last recorded PROMIS Pain Interference
Time frame: Baseline then weekly and monthly until 3 months (acute) or 6 months (chronic)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (8a) measures in those with intractable pain as defined and compared with surgical multifidus intervention studies
Comparison between the experimental and active control interventions crosswalked with the Oswestry Disability outcomes in multifudus electrical stimulation studies.
Time frame: Initial through 6 month measurements (or 13 week if chronic enrolled as acute)
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, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: up to 36 months after publication of results
Access criteria: researchers providing approved methodologically sound proposals or requests
Ran from Jun 2022 to primary completion in Jul 2024, 24 months.
Of 26 interventional studies with no phase under Pain, Intractable, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 34. This study's 24 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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