Randomized, Double-Blind Study of Wireless Sub-Threshold Nerve Stimulation for Treating Chronic Osteoarthritic Knee Pain

What this Trial Is About

Researchers are evaluating the potential benefits and risks of active sub-threshold wireless neuromodulation stimulation for treating chronic knee pain caused by osteoarthritis. This trial aims to compare active stimulation versus no stimulation sham in reducing pain, with the primary goal of measuring the number of participants who experience at least a 50% decrease in pain on a visual analog scale after one month. Participants first undergo a diagnostic injection to confirm temporary pain relief before receiving a 7-day trial implant of the stimulation device near the target nerve. Those reporting more than 50% pain relief during this test proceed to receive a permanent implant under sedation. After a healing period of 10 days, participants are randomized to receive either active sub-threshold stimulation or sham stimulation for 30 days while both participants and staff remain unaware of group assignments. Stimulation programs include various high-frequency options. Throughout the study, participants attend in-person visits at 1 week, 1 month, 3 months, and 6 months post-randomization for physical exams, pain scales, knee function assessments, range of motion, work status, and medication use. Additional phone follow-ups are conducted at 12, 18, and 24 months to assess long-term pain relief and any adverse events. The study collects multiple outcome measures to evaluate the treatments impact on pain and physical function over time.

Freedom-1 Study for Chronic Knee Pain