Home › Trials › NCT03877653

Wireless neuromodulation for chronic knee pain relief

Double-Blinded Randomized Control Trial of Knee Pain Utilizing Sub-Threshold Peripheral Nerve Stimulation

Not applicable Interventional Curonix LLC · NCT03877653

This study is testing a new wireless treatment to see if it can help people with chronic knee pain from osteoarthritis feel less pain.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorCuronix LLC Industry-sponsored
Locations13 sites (Placentia, California and 12 other locations)
Trial IDNCT03877653 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of active sub-threshold stimulation using wireless neuromodulation in patients suffering from chronic knee pain due to osteoarthritis. Participants will be screened and selected based on specific inclusion and exclusion criteria, and those who qualify will undergo a diagnostic injection to assess their suitability for the trial. The primary endpoint is to measure pain relief, defined as a 50% reduction in pain on a visual analog scale, comparing baseline pain levels to those recorded one month after treatment. The study will involve a total of at least 84 subjects to ensure robust data for evaluation.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with chronic, function-limiting knee pain from osteoarthritis who have not found relief from at least two less invasive treatments.

Not a fit: Patients with acute knee pain or those who have not previously tried conservative treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide significant pain relief for patients suffering from chronic knee pain, improving their quality of life.

How similar studies have performed: While the approach of wireless neuromodulation is relatively novel, similar neuromodulation techniques have shown promise in other studies for pain management.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

i. Subject is over 18 years of age; ii. Subjects with a history of chronic, function-limiting (m-MPS \>6/10) knee pain from osteoarthritis of at least three months in duration with or without prior surgeries; iii. Subject has been diagnosed with Kellgren-Lawrence Grade II or III knee osteoarthritis, confirmed by X-ray studies conducted in the last year; iv. Subject has been examined and has been deemed to be an appropriate candidate for the procedure, including chronic knee pain in patients post total knee replacement (TKR); v. Subjects who are able to understand this investigation, and give voluntary, written informed consent to participate in this study; vi. Subjects who are able to co-operate with the study procedures and are willing to return to the center for all the required post-operative follow-ups; vii. Documented failure of at least two less invasive treatment modalities including physical therapy, intra-articular steroids and/or oral NSAIDS; viii. Subject has not had recent invasive surgical procedures of the knee within the following intervals in relation to the time of signing Informed Consent:- 2 weeks for steroid injection - 4 weeks for radiofrequency, cryoablation or hyaluronic acid (HA) injection ix. Subject noted good (\> 75%) but only temporary relief for at least 2 hours from an infrapatellar saphenous nerve injection with local anesthetic; x. Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of assessment of a Clinical Psychologist.

Exclusion Criteria:

xi. Significant contralateral knee pain that would influence their level of activity greater to 6 on the modified-Mankosky Pain Scale; xii. Hip or foot pain greater than knee pain; xiii. Neurogenic or vascular claudication; xiv. Subject has been diagnosed with Kellgren-Lawrence Grade IV knee osteoarthritis, confirmed by X-ray studies conducted in the last year; xv. Uncontrolled major depression or uncontrolled psychiatric disorders; xvi. Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, infection, unstable angina, and severe chronic obstructive pulmonary disease; xvii. Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function (eg. Rheumatoid arthritis, severe spinal stenosis, activity-limiting cardiac disease); xviii. Women who are pregnant or planning to become pregnant, lactating; xix. Body mass index (BMI) greater than 40 (morbid obesity); xx. Subjects with multiple complaints involving concomitant knee, foot, or ankle pathology or radiculopathy, that will not be amenable to study due to the overlap of pain complaints; xxi. Subject has been examined and has been deemed to be inappropriate for the procedure based on anatomical restrictions; xxii. Lymphedema or stasis ulcers or other conditions that would compromise the surgical site; xxiii. History of adverse reaction to local anesthetic drugs; xxiv. Worker's compensation claimants; xxv. Incarcerated or has an ankle position locator; xxvi. Documented allergy to device material components; xxvii. Known or suspected substance abuse within the last 2 years; xxviii. Pacemaker or implanted defibrillator; xxix. Participation in another clinical study that could confound the results of this study; xxx. Based on the opinion of the investigator any legal or medical concerns that would preclude his/her enrollment in the study or potentially confound the results; xxxi. Any other implanted active medical devices in the same site.

Where this trial is running

Placentia, California and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Osteoarthritic Knee PainPNSChronicPainWirelessNeuromodulationkneeosteoarthritic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.