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Impact of DuoTherm Compared to TENS on Pain and Disability With Acute and Chronic Low Back Pain

NCT04494698 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-07-18

No results posted yet for this study

Summary

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

Conditions

  • Acute Low-back Pain
  • Chronic Low-back Pain
  • Pain, Intractable

Interventions

DEVICE

Duotherm VibraCool Back Device

Active New multimodal pain device

DEVICE

TENS 8-channel unit

LG Smart TENS unit

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

  • Amy Baxter, MD · Pain Care Labs (a dba of MMJ Labs)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
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
2025-06-24
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 NCT04494698 on ClinicalTrials.gov