Precise management system for chronic intractable pain patients implanted with spinal cord stimulation based on a...

Area of Science:

• Neurology
• Pain Management
• Digital Health

Background:

• Spinal cord stimulation (SCS) is a validated surgical treatment for chronic intractable pain.
• Maintaining long-term effectiveness of SCS remains a challenge.
• A novel management paradigm integrating smartphone technology and remote programming is introduced.

Purpose of the Study:

• To evaluate the clinical effectiveness and safety of a precise, App-based management system for chronic pain.
• To assess the non-inferiority of this patient-centered system compared to standard online follow-ups.
• To explore experiences with precision medicine in pain management.

Main Methods:

• A randomized controlled trial (RCT) involving 82 participants with chronic intractable pain.
• Participants receive SCS and are randomized (1:1) to an experimental or control group.
• The experimental group uses a smartphone app for daily pain monitoring (VAS) and self-adjusted stimulation parameters, with interventional appointments triggered by a pain threshold.

Main Results:

• The primary outcome is health status and quality of life, measured by the EQ-5D-5L questionnaire.
• EQ-5D-5L utility values will be assessed at baseline and at 1, 3, and 6 months post-operatively.
• Stimulation effectiveness is tested post-implantation, with >50% VAS reduction required for randomization.

Conclusions:

• The PreMaSy study will determine the effectiveness and safety of a novel App-based, patient-centered, self-assessment management system for chronic intractable pain.
• The RCT will compare this system against monthly online follow-ups to establish non-inferiority.
• The study is expected to provide valuable insights into precision medicine applications for pain management.