Mobile app for managing chronic intractable pain with spinal cord stimulation
Precise Management System (PreMaSy) of Chronic Intractable Pain Based on a Remote and Wireless Spinal Cord Stimulation System
This study is testing whether a mobile app can help people with chronic pain who are using spinal cord stimulation feel better and manage their pain more effectively compared to regular follow-up care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Tsinghua Chang Gung Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05761392 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate a new management system for patients suffering from chronic intractable pain who are undergoing spinal cord stimulation (SCS). Participants will be randomly assigned to either a control group, receiving standard follow-up care, or an interventional group, utilizing a mobile app to monitor pain levels and adjust stimulation settings. The study seeks to determine if this innovative approach can enhance quality of life and pain relief compared to conventional methods. The trial will assess the feasibility of remote management in a large population of chronic pain patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic intractable pain lasting more than three months and inadequate response to conservative treatments.
Not a fit: Patients with bleeding disorders, mental or cognitive impairments, or unsuitable spinal conditions for implantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and pain management for patients with chronic intractable pain.
How similar studies have performed: Previous studies have shown the effectiveness of spinal cord stimulation, but the use of a mobile app for remote management is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have been clinically diagnosed with chronic, intractable pain for more than three months. * At enrollment, the average pain intensity is no least than 5 out of 10 cm on visual analogue scale. * At enrollment, the age is no younger than 18-year-old. * Ineffective or unsatisfactory conservative treatments, including but limited to: oral medication, nerve block, epidural corticosteroids, physical and psychological rehabilitation therapy, and chiropractic care. * Voluntary to take the trial and sign the informed consent. * Good compliance and ability to complete post-operative follow-ups. * Basic ability to read and use a mobile phone or having a caregiver who can. Exclusion Criteria: * Bleeding complications or coagulation disorders. * Mental or cognitive disorders leading to inability to complete implantation surgery or post-operative follow-up. * Issues with spinal cord or vertebrates that are not suitable for implantation surgery. * Systemic active infections or local infections around the surgery area. * Pregnancy, breast-feeding, plan to be pregnant or unwilling to use contraceptive methods. * Metastatic malignant tumors or untreated malignant tumors. * Life expectancy of less than one year. * Already provided with a medication pump and/or other implanted devices. * Need for therapy or examination that must not have an implanted pulse generator (IPG), such as magnetic resonance imaging (MRI) and thermo-therapy. * Heavily addicted to alcohol or drugs. * VAS improvement less than 50% or stimulation intolerance during the test period. * Unable to complete long-term online follow-ups because of hardware issues such as internet, mobile phones, and so on. * Unwilling to participate. * Other inappropriate situations determined by the investigators.
Where this trial is running
Beijing
- Beijing Tsinghua Chang Gung Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Yang Lu, MD — Beijing Tsinghua Chang Gung Hospital
- Study coordinator: Yang Lu, MD
- Email: lya02121@btch.edu.cn
- Phone: 18600391166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.