RecruitingNot ApplicableNCT03877653

Freedom-1 Study for Chronic Knee Pain

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


Sponsor

Curonix LLC

Enrollment

100 participants

Start Date

Sep 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

To demonstrate the potential benefits and risk of active sub-threshold stimulation in the treatment of chronic knee pain as compared to subjects that did not have active stimulation. Improvement will be assessed in relation to the clinical outcome measures of pain, with primary endpoint; Pain relief rate as measured by the number of subjects with greater or equal to a 50% decrease in pain on the visual analog scale, comparing baseline to the 1-month follow-up.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Wireless neuromodulation for people with osteoarthritic knee pain. The study is currently recruiting participants at 13 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEWireless neuromodulation

A needle and catheter are carefully inserted near the enervated nerve. The stimulator is then placed through the catheter close to the nerve. The proximal end of the stimulator is then sutured underneath the skin to prevent migration.


Locations(13)

Western Clinical Research

Placentia, California, United States

Colorado Pain Care, LLC

Denver, Colorado, United States

Holy Cross Hospital, Inc

Fort Lauderdale, Florida, United States

Florida Joint Care Institute

Trinity, Florida, United States

Southern Pain and research

Jasper, Georgia, United States

Vista Clinical Research/Summit Spine & Joint Centers

Newnan, Georgia, United States

Desert Orthopaedic Center

Las Vegas, Nevada, United States

Orthopedic Associates of Southwest Ohio

Dayton, Ohio, United States

Premier Pain Treatment

Loveland, Ohio, United States

Kettering Health

Miamisburg, Ohio, United States

Austin Orthopedic Institute

Austin, Texas, United States

Performance pain and sports medicine

Houston, Texas, United States

Advanced Spine and Pain Center

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT03877653


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