Freedom-1 Study for Chronic Knee Pain

This study is testing a treatment called wireless neuromodulation for chronic knee pain caused by osteoarthritis. This involves carefully placing a small stimulator near a nerve in your knee to help with pain. To join, you must be over 18 and have had ongoing knee pain from osteoarthritis for at least three months. Your osteoarthritis must also be confirmed by an X-ray from the last year. The study aims to see if this active stimulation can reduce pain by at least 50% after one month, compared to those who don't receive active stimulation. The study is currently recruiting participants.

Study design
This interventional study plans to enroll 100 participants. It compares those who receive active wireless neuromodulation to those who do not.
What's involved
You would undergo a diagnostic injection to see if your pain temporarily improves. If it does, you would then have a procedure to implant the stimulator under local anesthetic.
Compensation
Not stated in the trial record.
Follow-up
Your pain relief will be measured at one month after the treatment.

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NCT03877653

Freedom-1 Study for Chronic Knee Pain

Recruiting
NAAges 18+InterventionalTreatment
Curonix LLC
~100 participants
Updated 2025-02-13 on ClinicalTrials.gov
What's tested:Wireless neuromodulation

At a glance

Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Responder rate
Measured over 1 month
Osteoarthritic Knee Pain
13 sites across 7 states
Ohio3
Texas3
Florida2
Georgia2
California1
Colorado1
Nevada1

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  • Responder rate1 month

    A. Percentage of patients with at least 50% improvement in the knee pain identified at baseline compared to 3 months post full implant of the StimQ PNS System pain identified at baseline compared to 6 months post full implant of the Freedom PNS system with the VAS