Clinical trial NCT05511181: BioWave High-frequency Neurostimulation Versus TENS for the Treatment of Chronic Low Back Pain
Official title: High-frequency Sinusoidal Neurostimulation (BioWave) Versus Transcutaneous Electrical Nerve Stimulation (TENS) for the Treatment of Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lumbar Pain Syndrome
Low Back Pain
Keywords: Chronic Low Back Pain
Lumbar Pain Syndrome
Lead sponsor: BioWave Corporation
Sponsor class: INDUSTRY
Collaborators: name: Center For Interventional Pain and Spine
name: Yale University
name: University of Wisconsin, Madison
First posted: 2022-08-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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. Patients will start a 30 minute treatment session with either BioWave therapy or TENS device followed by a 30 minute washout and ending with a final 30 minute treatment. Patients will then be instructed to perform two 30 minute treatment sessions daily at home for 2 weeks. Follow-up will be after 2 weeks and the patients will be assessed in clinic for physiologic measures of pain response. A washout period of 2 weeks will follow and the patients will crossover to receive the alternative treatment.

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

Primary outcomes:
measure: Change in Brief Pain Inventory relative to baseline
timeFrame: completed pre-treatment at the initiation of the study (1st in-clinic treatment), at the 2 week follow up, at week 4, prior to the 2nd in-clinic treatment, and at the 6 week follow up
measure: Change in Visual Analogue Scale relative to baseline
timeFrame: completed pre-treatment and post treatment for the in-clinic visit at week 1 and week 4, as well as at the 2 week and 6 week follow up visits
measure: Change in Patient Global Impression of Change relative to baseline
timeFrame: completed pre-treatment and post treatment for the in-clinic visit at week 1 and week 4, as well as at the 2 week and 6 week follow up visits
measure: Change in Promis-29 relative to baseline
timeFrame: completed pre-treatment at the initiation of the study (1st in-clinic treatment), at the 2 week follow up, at week 4, prior to the 2nd in-clinic treatment, and at the 6 week follow up
Secondary outcomes:
measure: Global assessment of patient impression and perception of pain
timeFrame: completed at the 2 week follow up and the 6 week follow up
measure: Global physician assessment of patient improvement
timeFrame: completed at the 2 week follow up and the 6 week follow up
measure: Change in Blood Pressure (BP) relative to baseline
timeFrame: pre and post at first in-clinic treatment at week 1 and second in-clinic treatment at week 4
measure: Global assessment of patient impression and perception of quality of life
timeFrame: completed at the 2 week follow up and the 6 week follow up
measure: Change in Heart Rate (HR) relative to baseline
timeFrame: pre and post at first in-clinic treatment at week 1 and second in-clinic treatment at week 4
measure: Change in Respiratory Rate (RR) relative to baseline
timeFrame: pre and post at first in-clinic treatment at week 1 and second in-clinic treatment at week 4
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale
state: Connecticut
city: Huntersville
country: United States
facility: Carolinas Pain Center
state: North Carolina
city: Lancaster
country: United States
facility: Center for Interventional Pain and Spine
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Center For Interventional Pain and Spine
name: Michael Fishman, MD
role: PRINCIPAL_INVESTIGATOR
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