Remote and Wireless Spinal Cord Stimulation System for Managing Chronic Intractable Pain Using a Mobile App for Precise Patient Monitoring

What this Trial Is About

Researchers are evaluating a new management system using remote and wireless spinal cord stimulation SCS for patients with chronic, stubborn pain. This study aims to determine if this precise management system can improve patients quality of life and relieve long-term pain better than conventional follow-up methods. The study will also assess whether this approach can be applied broadly to chronic pain patients. Participants will be randomly assigned to either a control or interventional group to compare outcomes. All participants will receive standard SCS implantation surgery. Those in the interventional group will use a mobile phone app to record daily pain levels and monthly health status, enabling customized stimulation adjustments based on these self-assessments. The control group will follow the usual care with standard SCS surgery and conventional follow-ups at 1, 3, and 6 months after surgery. In the interventional group, physicians receive warnings if pain scores exceed thresholds, prompting remote consultations and stimulation setting adjustments. Participants will attend conventional follow-up visits at 1, 3, and 6 months post-operation, during which pain and quality of life questionnaires will be completed. Assessments include the EuroQol five-dimensional questionnaire EQ-5D-5L, visual analogue scale VAS for pain intensity, Pittsburgh Sleep Quality Index PSQI, and global impression scales. The study will monitor changes from baseline in these measures to evaluate health, pain, sleep quality, and overall patient impressions, with safety and adherence tracked throughout the study duration.

APP-based Precise Management System of Chronic Intractable Pain