RecruitingNot ApplicableNCT05761392

APP-based Precise Management System of Chronic Intractable Pain

Precise Management System (PreMaSy) of Chronic Intractable Pain Based on a Remote and Wireless Spinal Cord Stimulation System

Sponsor

Beijing Tsinghua Chang Gung Hospital

Enrollment

120 participants

Start Date

Sep 26, 2022

Study Type

INTERVENTIONAL

Conditions

Pain, Chronic Pain, Intractable

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria14

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.

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Interventions

OTHERPrecise management

The daily pain state assessments contain three components, the visual analogue scale (VAS) based on pain intensity, time-intensity curve throughout the day, and pain locations. The VAS scores from the first seven post-operative days will be collected as the baseline data. The interventional threshold will be determined by adding 30 mm (if the scale length were 100 mm) to the baseline mean. If participants score above the threshold three times in a row, a warning will be sent to their physicians. A remote meeting will be scheduled and stimulation settings will be adjusted accordingly.