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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Tsinghua Chang Gung Hospital
RECRUITING
Beijing
Contact Information
Primary
Yang Lu, MD
lya02121@btch.edu.cn
18600391166
Time Frame
Start Date: 2022-09-26
Estimated Completion Date: 2026-09-25
Participants
Target number of participants: 120
Treatments
Experimental: Precise management
Participants will be asked to take daily pain state and monthly health condition assessments.~A warning for the physicians will be given when participants reach daily assessment threshold. Remote interventional meeting will be scheduled and stimulation parameters will be adjusted accordingly.~Participants will also be asked to take conventional follow-up at 1-, 3-, and 6-month post-operative.
No_intervention: Conventional management
Participants will be only asked to take conventional follow-ups at 1-, 3-, and 6-month post-operative. During these follow-ups, they will be asked to score VAS based on general pain state, and take questionnaires including EQ-5D-5L, PSQI, PGIC, CGI-I.
Related Therapeutic Areas
Sponsors
Leads: Beijing Tsinghua Chang Gung Hospital

This content was sourced from clinicaltrials.gov