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

June 30, 2023 updated by: Michael Fishman, MD, BioWave Corporation

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Carolinas Pain Center
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • Center for Interventional Pain and Spine
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BioWave
BioWaveGO is a FDA 510(k) cleared high frequency neurostimulator. Patients that are first randomized to the BioWave arm will receive a 30 minute treatment in the clinic with a BioWaveGO device followed by a 30 minute washout and ending with a final 30 minute treatment. Data will be collected before, and after the final treatment. Patients will then be instructed to take the BioWaveGO device home and perform two 30 minute treatment sessions daily at home for 2 weeks. Follow-up in the clinic will be after the 2-week treatment period and the patients will be assessed in clinic for physiologic measures of pain response. A washout period of 2 weeks will follow, the patients will return to the clinic at week 4 and the patients will crossover to receive the TENS treatment (as described in the TENS arm).
Device: BioWave
The BioWave device is called BioWaveGO. It is a FDA 510(k) cleared high frequency sinusoidal neurostimulator
Active Comparator: TENS
Patients that are first randomized to the TENS arm will receive a 30 minute treatment in the clinic with an Intensity 5000 TENS device followed by a 30 minute washout and ending with a final 30 minute treatment. Data will be collected before, and after the final treatment. Patients will then be instructed to take the TENS device home and perform two 30 minute treatment sessions daily at home for 2 weeks. Follow-up in the clinic will be after the 2-week treatment period and the patients will be assessed in clinic for physiologic measures of pain response. A washout period of 2 weeks will follow, the patients will return to the clinic at week 4 and the patients will crossover to receive the BioWaveGO treatment (as described in the BioWave arm).
Device: TENS
The TENS device is called Intensity 5000. It is a FDA 510(k) cleared TENS device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Brief Pain Inventory relative to baseline
Time Frame: 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

Includes a validated short form assessment of pain and function;

Patient circles the number on a scale of 0 to 10, with 0 meaning no pain and 10 meaning "pain as bad as you can imagine"; a lower score means less pain and a higher score means more pain.

The higher the score, the worse the outcome.

Patient circles the one number that describes how, during the past 24 hours, pain has interfered with their life:

[Scale is between 0-10. 0 means it does not interfere, 10 meaning it completely interferes.

The higher the score, the worse the outcome.
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
Change in Visual Analogue Scale relative to baseline
Time Frame: 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
straight line with one end meaning no pain and the other end meaning the worst pain imaginable; patient marks a point on the line that matches the amount of pain he or she feels; the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity and a lower score indicates lower pain intensity
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
Change in Patient Global Impression of Change relative to baseline
Time Frame: 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
reflects a patient's belief about the efficacy of treatment; patients will be asked if there overall pain was very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse
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
Change in Promis-29 relative to baseline
Time Frame: 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
Changes from PROMIS-29 scores relative to baseline for each domain evaluated (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity). The first seven domains are assessed with 4 questions each; Pain Intensity is measured with a single 11-point numeric rating scale from 0 (no pain) to 10 (worst imaginable pain). High scores represent more of the domain being measured. On symptom-oriented domains, higher scores signify worse pain. On function-oriented domains, higher scores signify better functioning.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global assessment of patient impression and perception of pain
Time Frame: completed at the 2 week follow up and the 6 week follow up

reflects the patient's own assessment of the impact of their condition

reflects a patient's belief about the efficacy of treatment; patients will be asked if their overall impression and perception of pain was very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse
completed at the 2 week follow up and the 6 week follow up
Global physician assessment of patient improvement
Time Frame: completed at the 2 week follow up and the 6 week follow up

measures the overall response to treatment as assessed by the physician

physicians will be asked their overall impression of their patients' improvement was very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse
completed at the 2 week follow up and the 6 week follow up
Change in Blood Pressure (BP) relative to baseline
Time Frame: pre and post at first in-clinic treatment at week 1 and second in-clinic treatment at week 4
comparison of systolic and diastolic blood pressure measurements
pre and post at first in-clinic treatment at week 1 and second in-clinic treatment at week 4
Global assessment of patient impression and perception of quality of life
Time Frame: completed at the 2 week follow up and the 6 week follow up
reflects the patient's own assessment of their change in quality of life
completed at the 2 week follow up and the 6 week follow up
Change in Heart Rate (HR) relative to baseline
Time Frame: pre and post at first in-clinic treatment at week 1 and second in-clinic treatment at week 4
comparison of beats per minute
pre and post at first in-clinic treatment at week 1 and second in-clinic treatment at week 4
Change in Respiratory Rate (RR) relative to baseline
Time Frame: pre and post at first in-clinic treatment at week 1 and second in-clinic treatment at week 4
comparison of breaths per minute
pre and post at first in-clinic treatment at week 1 and second in-clinic treatment at week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioWave Corporation

Collaborators

Yale University
University of Wisconsin, Madison
Center For Interventional Pain and Spine

Investigators

  • Principal Investigator: Michael Fishman, MD, Center for Interventional Pain and Spine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Actual)

April 12, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

July 28, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOWAVEVSTENSLBP1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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