Double-Blinded Randomized Control Trial of Knee Pain Utilizing Sub-Threshold Peripheral Nerve Stimulation
Double-Blinded Randomized Control Trial of Knee Pain Utilizing Sub-Threshold Peripheral Nerve Stimulation
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Clinical Trial Information
Trial Contact: Melendez, Thomas L; Carlo, Charlene S; Monserrate, Francheska; Mondragon, Diana
Trial Phone: 321.841.6813 ; 321.841.1324 ; 321-841-1324 ; 3218414717
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IRB No: W24.109.08
Protocol Abbrev: FREEDOM-1
Principal Investigator: Shehzad H. Choudry, MD
Phase: Device: Non-significant Risk
Age Group: Adult
Treatment: Medical Device: Peripheral Nerve Stimulator for the Infrapatellar Saphenous Nerve
Therapies Involved: Procedural
ClinicalTrials.gov ID: NCT03877653
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Objective
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, measured by the number of subjects with greater or equal to a 50% decrease in pain level at 1-month follow up after randomization, compared to the average pain level captured at baseline.
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Key Eligibility
Chronic, function limiting, knee pain from osteoarthritis, who has had documented failure of at least two less invasive treatment modalities, including: Physical therapy, Intra-articular steroids and/or Oral NSAIDS.
