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Neurostimulation

BioWave for Chronic Pain (BioWave Trial)

N/A
Waitlist Available
Led By Michael Fishman, MD
Research Sponsored by BioWave Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 must have signed consent before study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

BioWave Trial Summary

This trial will compare two therapies (BioWave & TENS) to help with chronic low back pain and measure their impact on physical activity, patient perception, and daily life.

Eligible Conditions
  • Chronic Pain
  • Lower Back Pain

BioWave Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

BioWave Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain
Change in Patient Global Impression of Change relative to baseline
Change in Promis-29 relative to baseline
+1 more
Secondary outcome measures
Bronchial Provocation Tests
Body Weight Changes
Change in Respiratory Rate (RR) relative to baseline
+3 more

BioWave Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BioWaveExperimental Treatment1 Intervention
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).
Group II: TENSActive Control1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BioWave
2022
N/A
~120

Find a Location

Who is running the clinical trial?

Center For Interventional Pain and SpineOTHER
3 Previous Clinical Trials
280 Total Patients Enrolled
1 Trials studying Chronic Pain
50 Patients Enrolled for Chronic Pain
BioWave CorporationLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
University of Wisconsin, MadisonOTHER
1,176 Previous Clinical Trials
3,011,886 Total Patients Enrolled
5 Trials studying Chronic Pain
53,454 Patients Enrolled for Chronic Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate amount of participants taking part in this experiment?

"In order to successfully launch this trial, 120 candidates who match the defined criteria must be recruited. Those interested may sign up at Yale in New Haven, Connecticut or Center for Interventional Pain and Spine in Lancaster, Pennsylvania."

Answered by AI

What are the intended outcomes of this research?

"This investigation's primary goal is to evaluate the transformation in Promis-29 from baseline. Secondary objectives consist of a Global Physician Assessment of Patient Improvement, Global Assessment of Patient Impression and Perception of Quality of Life, as well as Change in Respiratory Rate relative to initial values at commencement (1st In-Clinic Treatment), follow up 2 weeks later, 4 weeks thereafter prior to second clinic visit, and 6 week final review."

Answered by AI

Are there any available slots for new participants in this experimental study?

"Affirmative. According to the information shared on clinicaltrials.gov, this research is currently searching for participants and was initially posted on August 15th 2022. Last updated on December 6th of the same year, it requires a total of 120 patients from 4 distinct sites."

Answered by AI

Is this study open to individuals below the age of eighty-five?

"The requirements for this trial state that only volunteers aged 18 to 85 may participate. Additionally, there are 44 studies dedicated specifically for those younger than 18 and 609 trials designed for adults over 65 years of age."

Answered by AI

Is it possible for me to participate in this research?

"This trial seeks to enrol 120 individuals with lumbar discomfort, aged between 18 and 85. In order to qualify for participation, applicants must have granted consent in writing prior to the start of the study; be over 45 kgs in weight with a BMI lower than 40 kg/m2; present pain levels higher or equal to 5 on their baseline assessment; maintained consistent dosages of medication for two weeks before enrollment; and suffer from chronic low back pain as diagnosed by medical professionals."

Answered by AI

How many medical establishments are carrying out this research experiment?

"Selected clinical sites for this investigation include Yale in New Haven, Connecticut; Center for Interventional Pain and Spine in Lancaster, Pennsylvania; University of Wisconsin in Madison, Wisconsin; plus 4 extra medical establishments."

Answered by AI
~46 spots leftby Mar 2025