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Chronic PainBioWaveNCT05511181

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

A study testing BioWave and TENS in people with Chronic Pain and Lumbar Pain Syndrome, run by BioWave Corporation at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Chronic Pain, Lumbar Pain Syndrome, Low Back Pain
What is being tested?
BioWave and TENS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
4 sitesUnited States
Study dates
15 Aug 2022to 30 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Carolinas Pain Center

    Huntersville, North Carolina, 28078

  • Center for Interventional Pain and Spine

    Lancaster, Pennsylvania, 17601

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • Yale

    New Haven, Connecticut, 06519

Other trials in United States

About this study

Official title: High-frequency Sinusoidal Neurostimulation (BioWave) Versus Transcutaneous Electrical Nerve Stimulation (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.

Read the 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.

Being tested
BioWave, TENS
Keywords
Chronic Low Back Pain, Lumbar Pain Syndrome
Medical subject headings
Chronic Pain, Somatoform Disorders, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BioWaveDevice

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

  • TENSDevice

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

Study groups in NCT05511181
Study groupRoleWhat they receive
BioWaveExperimentalBioWaveGO 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).
Receives: Device: BioWave
TENSActive comparatorPatients 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).
Receives: Device: TENS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. 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

    Measured: 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

  3. 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

    Measured: 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

  4. 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.

    Measured: 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 outcomes (6)

  1. 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

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

  2. 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

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

  3. Change in Blood Pressure (BP) relative to baseline

    comparison of systolic and diastolic blood pressure measurements

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

  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

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

  5. Change in Heart Rate (HR) relative to baseline

    comparison of beats per minute

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

  6. Change in Respiratory Rate (RR) relative to baseline

    comparison of breaths per minute

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2022
  2. Study start15 Aug 2022
  3. Primary completion12 Apr 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05511181
Sponsor's protocol ID
BIOWAVEVSTENSLBP1
Acronym
BioWave
Status last verified
Jun 2023
First submitted
28 Jul 2022
Last updated
3 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Vance CG, Dailey DL, Rakel BA, Sluka KA. Using TENS for pain control: the state of the evidence. Pain Manag. 2014 May;4(3):197-209. doi: 10.2217/pmt.14.13.

    PubMed 24953072

  • Hegarty DA, Bretherton B. An Open-Label Pilot Study Investigating Noninvasive High-Frequency Peripheral Nerve Fiber Stimulation in Chronic Pain. Pain Pract. 2021 Jun;21(5):578-587. doi: 10.1111/papr.12993. Epub 2021 Jan 27.

    PubMed 33369130

  • S.Diwan, R. F. Eliazo, H. C. Hemmings, S. Panchal: Symptomatic Treatment Of Chronic Low Back Pain: Determination Of Optimal Signal Frequency And Preliminary Efficacy Of A Targeted Non-Invasive Electronic Pain Control Device. Journal of the International Anesthesia Research Society, ANESTH ANALG ABSTRACTS 2003; 96; S-1-S-293

  • Kang RW, Lewis PB, Kramer A, Hayden JK, Cole BJ. Prospective randomized single-blinded controlled clinical trial of percutaneous neuromodulation pain therapy device versus sham for the osteoarthritic knee: a pilot study. Orthopedics. 2007 Jun;30(6):439-45. doi: 10.3928/01477447-20070601-11. No abstract available.

    PubMed 17598487

  • Wanich T, Gelber J, Rodeo S, Windsor R: A Randomized Placebo Controlled Study To Determine Safety and Efficacy In Terms Of Pain Reduction, Increased Range Of Motion, And Reduced Pain Medications, For A Novel Percutaneous Neuromodulation Pain Therapy Device ("Biowave P ENS ®") Following Post - Operative Treatments For Total Knee Replacement Procedures. Poster Presentation American Academy of Orthopaedic Surgeons February 2009

  • Khadilkar A, Odebiyi DO, Brosseau L, Wells GA. Transcutaneous electrical nerve stimulation (TENS) versus placebo for chronic low-back pain. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD003008. doi: 10.1002/14651858.CD003008.pub3.

    PubMed 18843638

  • Radhakrishnan R, Sluka KA. Deep tissue afferents, but not cutaneous afferents, mediate transcutaneous electrical nerve stimulation-Induced antihyperalgesia. J Pain. 2005 Oct;6(10):673-80. doi: 10.1016/j.jpain.2005.06.001.

    PubMed 16202960

  • Levin MF, Hui-Chan CW. Conventional and acupuncture-like transcutaneous electrical nerve stimulation excite similar afferent fibers. Arch Phys Med Rehabil. 1993 Jan;74(1):54-60.

    PubMed 8420521

  • Hughes N, Bennett MI, Johnson MI. An investigation into the magnitude of the current window and perception of transcutaneous electrical nerve stimulation (TENS) sensation at various frequencies and body sites in healthy human participants. Clin J Pain. 2013 Feb;29(2):146-53. doi: 10.1097/AJP.0b013e3182579919.

    PubMed 23183261

  • DeSantana JM, Da Silva LF, De Resende MA, Sluka KA. Transcutaneous electrical nerve stimulation at both high and low frequencies activates ventrolateral periaqueductal grey to decrease mechanical hyperalgesia in arthritic rats. Neuroscience. 2009 Nov 10;163(4):1233-41. doi: 10.1016/j.neuroscience.2009.06.056. Epub 2009 Jul 2.

    PubMed 19576962

  • Dailey DL, Rakel BA, Vance CGT, Liebano RE, Amrit AS, Bush HM, Lee KS, Lee JE, Sluka KA. Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia. Pain. 2013 Nov;154(11):2554-2562. doi: 10.1016/j.pain.2013.07.043. Epub 2013 Jul 27.

    PubMed 23900134

  • Hurlow A, Bennett MI, Robb KA, Johnson MI, Simpson KH, Oxberry SG. Transcutaneous electric nerve stimulation (TENS) for cancer pain in adults. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD006276. doi: 10.1002/14651858.CD006276.pub3.

    PubMed 22419313

  • Kroeling P, Gross AR, Goldsmith CH; Cervical Overview Group. A Cochrane review of electrotherapy for mechanical neck disorders. Spine (Phila Pa 1976). 2005 Nov 1;30(21):E641-8. doi: 10.1097/01.brs.0000184302.34509.48.

    PubMed 16261102

  • Johnson MI, Mulvey MR, Bagnall AM. Transcutaneous electrical nerve stimulation (TENS) for phantom pain and stump pain following amputation in adults. Cochrane Database Syst Rev. 2015 Aug 18;8(8):CD007264. doi: 10.1002/14651858.CD007264.pub3.

    PubMed 26284511

  • Nnoaham KE, Kumbang J. Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD003222. doi: 10.1002/14651858.CD003222.pub2.

    PubMed 18646088

Questions about this trial

What is this clinical trial studying?

A study testing BioWave and TENS in people with Chronic Pain and Lumbar Pain Syndrome, run by BioWave Corporation at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05511181, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.

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