CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
BioWave +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/NCT05511181
NCT05511181N/ACompleted
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High-frequency Sinusoidal Neurostimulation (BioWave) Versus Transcutaneous Electrical Nerve Stimulation (TENS) for the Treatment of Chronic Low Back Pain

BioWave Corporation·interventional·Posted Aug 22, 2022·Updated Jul 3, 2023

In Brief

A clinical study evaluating BioWave and TENS for Chronic Pain and 2 related conditions. Completed, enrolled 120 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain, Lumbar Pain Syndrome, Low Back Pain
CountriesUnited States
CollaboratorsCenter For Interventional Pain and Spine, Yale University, University of Wisconsin, Madison

Timeline

N/ACompletedFinished
2023202420252026
First PostedAug 22, 2022
Enrollment StartAug 15, 2022
Primary CompletionApr 12, 2023
Study CompletionJun 30, 2023
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 3.9 years ago

Interventions

BioWavedevice

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

TENSdevice

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