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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pain, Lumbar Pain Syndrome, Low Back Pain

Intervention / Treatment
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* Device: BioWave
* Device: TENS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BioWave<br>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<br>* The BioWave device is called BioWaveGO. It is a FDA 510(k) cleared high frequency sinusoidal neurostimulator<br>|
| Active Comparator: TENS<br>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<br>* The TENS device is called Intensity 5000. It is a FDA 510(k) cleared TENS device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | comparison of breaths per minute | pre and post at first in-clinic treatment at week 1 and second in-clinic treatment at week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Low Back Pain, Lumbar Pain Syndrome