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Usability of a Multimodal External Neuromodulatory Device to Relieve Acute Low Back Pain

NCT04494841 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-10-21

Study results available
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Summary

Ten patients with acute or chronic low back pain will be invited to try a multimodal device for 20 minutes. Pain will be recorded prior to and after use, and feedback on the device will be elicited.

Conditions

  • Low Back Pain
  • Low Back Sprain
  • Low Back Pain, Recurrent

Interventions

DEVICE

Duotherm VibraCool Back Device

Low back plate belt with mechanicothermal and pressure intervention options.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Sport and Spine Rehab Clinical Research Foundation

    collaborator OTHER

  • MMJ Labs LLC

    lead INDUSTRY

Principal Investigators

  • Amy Baxter, MD · MMJ Labs LLC

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-01-17
Primary Completion
2021-01-20
Completion
2021-02-18
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 NCT04494841 on ClinicalTrials.gov