BioWave High-frequency Neurostimulation Versus TENS for the Treatment of 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