An interventional study of BioWave and TENS in Chronic Pain, Lumbar Pain Syndrome and Low Back Pain, sponsored by BioWave Corporation. Completed at 4 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by BioWave Corporation · Not applicable, Interventional, and Treatment
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.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 120 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →This is the only study on the registry with BioWave Corporation as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 BioWave device is called BioWaveGO. It is a FDA 510(k) cleared high frequency sinusoidal neurostimulator
The TENS device is called Intensity 5000. It is a FDA 510(k) cleared TENS device
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.
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
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
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
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
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
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.
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: pre and post at first in-clinic treatment at week 1 and second in-clinic treatment at week 4
Plan to share: No
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