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Completed

NCT Number: NCT05511181

BioWave High-frequency Neurostimulation Versus 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.

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Key information

Conditions

Chronic Pain Back Pain Low Back Pain Lumbar Pain Syndrome Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Somatoform Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BioWave

Device

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

TENS

Device

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

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

BioWave Corporation

Industry

Collaborators

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

Registry information

Official study title

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

Acronym: BioWave

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 22, 2022
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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