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Impact of DuoTherm on Opioid Use and Low Back Pain

NCT04491175 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-08-19

No results posted yet for this study

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)

Conditions

  • Opioid Use
  • Low Back Pain

Interventions

DEVICE

M-Stim

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

DEVICE

TENS

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.

Sponsors & Collaborators

  • Sport and Spine Rehab Clinical Research Foundation

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • MMJ Labs LLC

    lead INDUSTRY

Principal Investigators

  • Jena Slaski · Sport and Spine Clinical Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-23
Primary Completion
2024-07-09
Completion
2025-05-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04491175 on ClinicalTrials.gov