CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 160 enrolled
Drug / intervention
Duotherm VibraCool Back Device +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/NCT04494698
NCT04494698N/ACompleted
CompareCT.gov

Addressing Pain and Disability From Low Back Pain With an External Multimodal Neuromodulation Device

MMJ Labs LLC·interventional·Posted Jul 31, 2020·Updated Jul 18, 2025

In Brief

A clinical study evaluating Duotherm VibraCool Back Device and TENS 8-channel unit for Acute Low-back Pain and 2 related conditions. Completed, enrolled 160 participants across 2 sites.

Detailed Summary

Evaluate pain and disability change in Low Back Pain with DuoTherm Compared to Active Control

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Low-back Pain, Chronic Low-back Pain, Pain, Intractable
CountriesUnited States
CollaboratorsSport and Spine Rehab Clinical Research Foundation, National Institute on Drug Abuse (NIDA)

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 31, 2020
Enrollment StartJun 23, 2022
Primary CompletionJul 9, 2024
Study CompletionJun 24, 2025
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.9 years ago

Interventions

Duotherm VibraCool Back Devicedevice

Active New multimodal pain device

TENS 8-channel unitdevice

LG Smart TENS unit