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

Primary Purpose

Chronic Pain, Lumbar Pain Syndrome, Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BioWave

TENS

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Low Back Pain, Lumbar Pain Syndrome

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yale
Carolinas Pain Center
Center for Interventional Pain and Spine
University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BioWave

TENS

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Change in Brief Pain Inventory relative to baseline

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.

Change in Visual Analogue Scale relative to baseline

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

Change in Patient Global Impression of Change relative to baseline

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

Change in Promis-29 relative to baseline

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.

Secondary Outcome Measures

Global assessment of patient impression and perception of pain

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

Global physician assessment of patient improvement

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

Change in Blood Pressure (BP) relative to baseline

comparison of systolic and diastolic blood pressure measurements

Global assessment of patient impression and perception of quality of life

reflects the patient's own assessment of their change in quality of life

Change in Heart Rate (HR) relative to baseline

comparison of beats per minute

Change in Respiratory Rate (RR) relative to baseline

comparison of breaths per minute

Full Information

NCT ID

NCT05511181

First Posted

July 28, 2022

Last Updated

June 30, 2023

Sponsor

BioWave Corporation

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05511181

Brief Title

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

Acronym

BioWave

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

August 15, 2022 (Actual)

Primary Completion Date

April 12, 2023 (Actual)

Study Completion Date

June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

BioWave Corporation

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain, Lumbar Pain Syndrome, Low Back Pain

Keywords

Chronic Low Back Pain, Lumbar Pain Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BioWave

Arm Type

Experimental

Arm Description

Arm Title

TENS

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

BioWave

Intervention Description

The BioWave device is called BioWaveGO. It is a FDA 510(k) cleared high frequency sinusoidal neurostimulator

Intervention Type

Device

Intervention Name(s)

TENS

Intervention Description

The TENS device is called Intensity 5000. It is a FDA 510(k) cleared TENS device

Primary Outcome Measure Information:

Title

Change in Brief Pain Inventory relative to baseline

Description

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

Title

Change in Visual Analogue Scale relative to baseline

Description

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

Title

Change in Patient Global Impression of Change relative to baseline

Description

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

Title

Change in Promis-29 relative to baseline

Description

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

Secondary Outcome Measure Information:

Title

Global assessment of patient impression and perception of pain

Description

Time Frame

completed at the 2 week follow up and the 6 week follow up

Title

Global physician assessment of patient improvement

Description

Time Frame

completed at the 2 week follow up and the 6 week follow up

Title

Change in Blood Pressure (BP) relative to baseline

Description

comparison of systolic and diastolic blood pressure measurements

Time Frame

pre and post at first in-clinic treatment at week 1 and second in-clinic treatment at week 4

Title

Global assessment of patient impression and perception of quality of life

Description

reflects the patient's own assessment of their change in quality of life

Time Frame

completed at the 2 week follow up and the 6 week follow up

Title

Change in Heart Rate (HR) relative to baseline

Description

comparison of beats per minute

Time Frame

pre and post at first in-clinic treatment at week 1 and second in-clinic treatment at week 4

Title

Change in Respiratory Rate (RR) relative to baseline

Description

comparison of breaths per minute

Time Frame

pre and post at first in-clinic treatment at week 1 and second in-clinic treatment at week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Fishman, MD

Organizational Affiliation

Center For Interventional Pain and Spine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

Facility Name

Carolinas Pain Center

City

Huntersville

State/Province

North Carolina

ZIP/Postal Code

28078

Country

United States

Facility Name

Center for Interventional Pain and Spine

City

Lancaster

State/Province

Pennsylvania

ZIP/Postal Code

17601

Country

United States

Facility Name

University of Wisconsin

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24953072

Citation

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

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