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.
Inclusion Criteria (same cohort as enrolled with NCT04491175):
Exclusion Criteria:
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)
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, Sap, Icf, Csr
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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