Clinical Trial

APP-based Precise Management System of Chronic Intractable Pain

Study acronym: PreMaSy
Recruiting
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn about a new management system in chronic and stubborn pain patients who accept therapy of spinal cord stimulation (SCS). Usually, these patients are required to take long-term follow-ups to ensure that the stimulator works well. The main questions it aims to answer are: * Is it better to improve the patient's quality of life than the current conventional follow-up? * Is it better to relieve pain in the long term than the current conventional follow-up? * Is it possible to be applied to a large population of chronic pain patients? Participants will be randomly assigned to either a control group or an interventional group. Participants in the control group will be given the standard SCS implantation surgery and asked to complete the conventional follow-up (at least 1-, 3-, and 6-month post-operative). Participants in the interventional group will be given the standard SCS implantation surgery and asked to do the following things: * Take the daily pain self-assessment questions on a mobile phone APP. * Take the monthly healthy status self-assessment questionnaires on a mobile phone APP. * Take the conventional follow-up (at least 1-, 3-, and 6-month post-operative). Researchers will compare the two groups to see if the life quality of the interventional group is improved.
Trial Details
NCT Number NCT05761392
Lead Sponsor Beijing Tsinghua Chang Gung Hospital
Conditions Pain, Chronic, Pain, Intractable
Enrollment 120 participants
Start Date 2022-09-26
Primary Completion 2026-09-25 (estimated)
Study Completion 2026-09-25 (estimated)
Updated on ClinicalTrials.gov 2023-03-09