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Phase IV

High-frequency Sinusoidal Neurostimulation (BioWave) Versus Transcutaneous Electrical Nerve Stimulation (TENS) for the Treatment of Chronic Low Back Pain

  • Study HIC#:2000033385
  • Last Updated:02/07/2023

Do you have lower back pain?

Consider enrolling in a clinical trial comparing a noninvasive high-frequency neurostimulation device used by most professional sports teams versus a conventional TENS unit. You will have the opportunity to use both devices for a two-week period.

As compensation for completing the entire trial, you will have the choice of keeping either device.

  • Age18 years - 85 years
  • GenderBoth
  • Start Date09/13/2022
  • End Date02/28/2023

Trial Purpose and Description

Do you have lower back pain?

Consider enrolling in a clinical trial comparing a noninvasive high-frequency neurostimulation device used by most professional sports teams versus a conventional TENS unit. You will have the opportunity to use both devices for a two-week period.

As compensation for completing the entire trial, you will have the choice of keeping either device.

Eligibility Criteria

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

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