Multicenter Study of Differential Target Multiplexed Spinal Cord Stimulation for Chronic Back and Leg Pain in Adults

What this Trial Is About

This research aims to evaluate how well differential target multiplexed DTM spinal cord stimulation works to treat chronic back and leg pain in patients with conditions like Failed Back Surgery Syndrome and Persistent Spinal Pain Syndrome Type 2. The study will also compare outcomes between patients using paddle or surgical leads and those using percutaneous leads to see if there are differences in effectiveness. Participants will receive spinal cord stimulation using the DTM approach as the main treatment. This device-based therapy will be monitored over time, with evaluations conducted at 1 month, 6 months, and 12 months after implantation. The study will collect detailed information on pain intensity, medication use, functional ability, quality of life, and other factors related to pain and daily living. During the study, participants will undergo assessments including pain ratings using the Visual Analogue Scale, measures of disability, psychological factors, and healthcare use. Data on device parameters, battery consumption, and any technical issues will also be tracked. Safety will be monitored by recording any adverse events throughout the study period. Overall, the study involves regular follow-up visits and evaluations over a year to understand the impact of DTM spinal cord stimulation on chronic pain.

Differential Target Multiplexed Spinal Cord Stimulation