MedTrace Logo

BioWave High-frequency Neurostimulation Versus TENS for the Treatment of Chronic Low Back Pain

NCT05511181 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-07-03

No results posted yet for this study

Summary

This will be a multicenter randomized crossover clinical trial comparing the therapeutic efficacy of BioWave therapy versus TENS for the management of chronic low back pain. This study also aims to evaluate the impact of these therapies on physical activity, patient perception of therapeutic efficacy, and activities of daily living.

Conditions

Interventions

DEVICE

BioWave

The BioWave device is called BioWaveGO. It is a FDA 510(k) cleared high frequency sinusoidal neurostimulator

DEVICE

TENS

The TENS device is called Intensity 5000. It is a FDA 510(k) cleared TENS device

Sponsors & Collaborators

  • Center For Interventional Pain and Spine

    collaborator OTHER

  • Yale University

    collaborator OTHER

  • University of Wisconsin, Madison

    collaborator OTHER

  • BioWave Corporation

    lead INDUSTRY

Principal Investigators

  • Michael Fishman, MD · Center For Interventional Pain and Spine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2023-04-12
Completion
2023-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05511181 on ClinicalTrials.gov