APP-based Precise Management System of Chronic Intractable Pain

Chronic intractable pain is a disorder with complicated causes. The patient's quality of life is significantly reduced as a result of the patient's ongoing discomfort and the necessity for lengthy therapies. When patients don't respond well to medicine or other non-surgical treatments, spinal cord stimulation (SCS) is one of the surgical methods employed. The safety and effectiveness of SCS have previously been confirmed in numerous trials as a well-researched and clinically used therapy. However, the adjustment of SCS is complicated and its optimal effect relies on long-term regular follow-up. With the development of the internet, the investigators put forward a new system with remote and wireless SCS devices. Together with an exclusively developed mobile phone application, patients will be able to record their daily pain state and monthly health condition and make customized stimulation settings accordingly. This study is aimed to test the feasibility of this new precise management system. All participants will be randomly assigned to either interventional or control group. Participants in control group will be asked to take the conventional follow-up. Participants in interventional group will be additionally asked to take self-assessment on daily pain state and monthly health condition. The investigators hypothesized that this self-involved, closely monitored, and precisely adjusted system can significantly improve patients' quality of life in the long term and cut down both the financial expenses and time cost.

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.