The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce post-amputation pain. This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Proportion of Group 1 (Treatment) and Group 2 (Control) Subjects That Achieved ≥ 50% Reduction in All Qualifying Areas of Pain in the First 4 Weeks of Treatment
Timeframe: Baseline and Weeks 1-4 Post-Start of Treatment
Number of Subjects That Experienced at Least One Study-Related Adverse Event in Treatment and Control Groups
Timeframe: Each participant enrolled was assessed for adverse events from the time of informed consent through the 12-month follow up visit. The total assessment period was approximately 13 months for each participant.