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

NCT05511181 | Completed FDA Device

• 1 other identifier: BIOWAVEVSTENSLBP1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief 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 of daily living.

Conditions

Chronic Pain; Lumbar Pain Syndrome; Low Back Pain

Keywords

Chronic Low Back Pain; Lumbar Pain Syndrome

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Global assessment of patient impression and perception of pain

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

• Global physician assessment of patient improvement

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

• Change in Blood Pressure (BP) relative to baseline

  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

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

• Change in Heart Rate (HR) relative to baseline

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

Study Arms (2)

BioWave

EXPERIMENTAL

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

TENS

ACTIVE COMPARATOR

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

Interventions

BioWave DEVICE

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

BioWave

TENS DEVICE

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

TENS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioWave Corporation: lead
• Center For Interventional Pain and Spine: collaborator
• Yale University: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (4)

Yale

New Haven, Connecticut, 06519, United States

Location

Carolinas Pain Center

Huntersville, North Carolina, 28078, United States

Location

Center for Interventional Pain and Spine

Lancaster, Pennsylvania, 17601, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (17)

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• 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.

  PMID: 33369130 BACKGROUND

• 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

  BACKGROUND

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  BACKGROUND

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• 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.

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• 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.

  PMID: 19576962 BACKGROUND

• 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.

  PMID: 23900134 BACKGROUND

• 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.

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• 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.

  PMID: 16261102 BACKGROUND

• 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.

  PMID: 26284511 BACKGROUND

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  PMID: 18646088 BACKGROUND

• Rutjes AW, Nuesch E, Sterchi R, Kalichman L, Hendriks E, Osiri M, Brosseau L, Reichenbach S, Juni P. Transcutaneous electrostimulation for osteoarthritis of the knee. Cochrane Database Syst Rev. 2009 Oct 7;2009(4):CD002823. doi: 10.1002/14651858.CD002823.pub2.

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MeSH Terms

Conditions

Chronic Pain; Somatoform Disorders; Low Back Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Back Pain

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Michael Fishman, MD

  Center For Interventional Pain and Spine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 22, 2022
• Study Start: August 15, 2022
• Primary Completion: April 12, 2023
• Study Completion: June 30, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)