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

CompletedNot applicableNCT05511181
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Official title
High-frequency Sinusoidal Neurostimulation (BioWave) Versus Transcutaneous Electrical Nerve Stimulation (TENS) for the Treatment of Chronic Low Back Pain
Conditions
Interventions
Sponsor
BioWave Corporation
Collaborators
Center For Interventional Pain and Spine; Yale University; University of Wisconsin, Madison
Start date
2022-08-15
Primary completion
2023-04-12
Sex
All
Age range
from 18 Years to 85 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
4

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Subject must have signed consent before study entry * Subject must have a body weight of 45 kg or more and a body mass index (BMI) of 40 kg/m2 or less. * Subject must be aged 18-85 on the date of enrollment and subjects consecutively enrolled * Subject must have a qualifying baseline pain score of≥5 * Subject must have a stable pain medication regimen for a period of at least 2 weeks prior to study enrollment. Both medication dosages and total number of medications must be stable prior to initiation. * Subject's pain indication must be defined as chronic low back pain Exclusion Criteria: * Subject has a known history of allergic reaction or clinically significant intolerance to medical adhesives, glues, or textiles. * Subject is currently receiving chronic opioid therapy defined as \>30 morphine equivalents units per day (daily use for \>2 weeks) * Subject has an implanted spinal cord stimulator (SCS). * Subject has any clinically significant clinical, physical, laboratory, or radiographic finding at Screening that, in the opinion of the investigator, contraindicates study participation. * Subject is currently pregnant. * Subject has history of or current medical, surgical, post surgical, or psychiatric condition that would confound interpretation of safety, tolerability, or efficacy, (eg, uncontrolled diabetes mellitus, uncontrolled hypertension, hemodynamic instability, or respiratory insufficiency, cancer or palliative care). * Subject received an experimental drug or used an experimental medical device within 30 days prior to Screening or has previously participated in this trial. * Subject is unable to comply with the requirements of the study

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05511181