CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 160 enrolled
Drug / intervention
M-Stim +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04491175
NCT04491175N/ACompleted
CompareCT.gov

Addressing Opioid Use Disorder With an External Multimodal Neuromodulation Device: Development and Clinical Evaluation of DuoTherm for Opioid-Sparing Pain Relief in Acute and Chronic Low Back Pain

MMJ Labs LLC·interventional·Posted Jul 29, 2020·Updated Aug 19, 2025

In Brief

A clinical study evaluating M-Stim and TENS for Opioid Use and Low Back Pain. Completed, enrolled 160 participants across 2 sites.

Detailed Summary

Evaluate the difference in opioid use, pain intensity and pain interference in patients with moderate to severe low back pain using DuoTherm multimodal harmonic mechanical stimulation (M-Stim) unit compared to Transcutaneous Electrical Nerve Stimulation (TENS)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Use, Low Back Pain
CountriesUnited States
CollaboratorsSport and Spine Rehab Clinical Research Foundation, National Institute on Drug Abuse (NIDA)

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 29, 2020
Enrollment StartJun 23, 2022
Primary CompletionJul 9, 2024
Study CompletionMay 29, 2025
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.9 years ago

Interventions

M-Stimdevice

The casing for the device is a 54" belt with 3-button haptic controller for on-off, therapy cycles(8) and intensity(5) levels.

TENSdevice

LG SMART TENS stimulator is a portable electrotherapy devcie 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.