62
Participants
Start Date
October 28, 2022
Primary Completion Date
December 1, 2024
Study Completion Date
December 1, 2024
Percutaneous peripheral nerve stimulation system
All subjects underwent a 7-day baseline assessment (VAS score for at least 4 days) during the screening/baseline period. Eligible subjects underwent PNS surgery and implanted electrode leads and entered the 7-day test period. During the test period, subjects with an average VAS score improvement of ≥30%(VAS score for at least 4 days) will be randomly assigned to the experimental group (on state) or the control group (off state) in a 1:1 ratio for 7 days observation. All subjects were enrolled in the observation period until 28 days after implantation. Safety assessment was performed at a 14-day follow-up after removal of the device.
RECRUITING
Ke Ma, PhD, Shanghai
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER