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

Completed · Not applicable

Conditions studied: Chronic Pain, Lumbar Pain Syndrome, Low Back Pain

In brief

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.

Key facts

Study ID

NCT05511181

Run by

BioWave Corporation

People needed

120

Starts

2022-08-15

Expected to finish

2023-06-30

Last updated by the study team

2023-07-03

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Yale — New Haven, Connecticut, United States
• Carolinas Pain Center — Huntersville, North Carolina, United States
• Center for Interventional Pain and Spine — Lancaster, Pennsylvania, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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