Actively Recruiting
APP-based Precise Management System of Chronic Intractable Pain
Led by Beijing Tsinghua Chang Gung Hospital · Updated on 2023-03-09
120
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
APP-based Precise Management System of Chronic Intractable Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically diagnosed with chronic, intractable pain for more than three months
- Average pain intensity at enrollment is at least 5 out of 10 cm on visual analogue scale
- At least 18 years old at enrollment
- Have ineffective or unsatisfactory conservative treatments such as oral medication, nerve block, epidural corticosteroids, physical and psychological rehabilitation therapy, or chiropractic care
- Voluntary participation with signed informed consent
- Good compliance and ability to complete post-operative follow-ups
- Basic ability to read and use a mobile phone or have a caregiver who can
You will not qualify if you...
- Bleeding complications or coagulation disorders
- Mental or cognitive disorders preventing surgery or follow-up
- Spinal cord or vertebrae issues unsuitable for implantation surgery
- Systemic active infections or local infections near surgery area
- Pregnant, breastfeeding, planning pregnancy, or unwilling to use contraceptives
- Metastatic or untreated malignant tumors
- Life expectancy less than one year
- Already have a medication pump or other implanted devices
- Require therapy or exams incompatible with implanted pulse generator, such as MRI or thermotherapy
- Heavy addiction to alcohol or drugs
- Less than 50% improvement in pain or intolerance to stimulation during test period
- Unable to complete long-term online follow-ups due to hardware issues like internet or mobile phones
- Unwilling to participate
- Other inappropriate situations determined by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tsinghua Chang Gung Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yang Lu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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