The Use of Remote Programming for Spinal Cord Stimulation for Patients With Chronic Pain During the COVID-19 Outbreak in China.
Yan Han, Yang Lu, Dengyu Wang...
https://pubmed.ncbi.nlm.nih.gov/33751731Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05761392
Precise Management System (PreMaSy) of Chronic Intractable Pain Based on a Remote and Wireless Spinal Cord Stimulation System
Led by Beijing Tsinghua Chang Gung Hospital · Updated on 2023-03-09
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new management system using remote and wireless spinal cord stimulation (SCS) for patients with chronic, stubborn pain. This study aims to determine if this precise management system can improve patients' quality of life and relieve long-term pain better than conventional follow-up methods. The study will also assess whether this approach can be applied broadly to chronic pain patients. Participants will be randomly assigned to either a control or interventional group to compare outcomes. All participants will receive standard SCS implantation surgery. Those in the interventional group will use a mobile phone app to record daily pain levels and monthly health status, enabling customized stimulation adjustments based on these self-assessments. The control group will follow the usual care with standard SCS surgery and conventional follow-ups at 1, 3, and 6 months after surgery. In the interventional group, physicians receive warnings if pain scores exceed thresholds, prompting remote consultations and stimulation setting adjustments. Participants will attend conventional follow-up visits at 1, 3, and 6 months post-operation, during which pain and quality of life questionnaires will be completed. Assessments include the EuroQol five-dimensional questionnaire (EQ-5D-5L), visual analogue scale (VAS) for pain intensity, Pittsburgh Sleep Quality Index (PSQI), and global impression scales. The study will monitor changes from baseline in these measures to evaluate health, pain, sleep quality, and overall patient impressions, with safety and adherence tracked throughout the study duration.
CONDITIONS
Brief Title
APP-based Precise Management System of Chronic Intractable Pain
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Clinically diagnosed with chronic, intractable pain lasting more than three months
- Average pain intensity of at least 5 out of 10 on a visual analogue scale at enrollment
- Age 18 years or older at enrollment
- Ineffective or unsatisfactory conservative treatments such as oral medication, nerve block, epidural corticosteroids, physical and psychological rehabilitation, 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 conditions unsuitable for implantation surgery
- Systemic active infections or local infections near surgery area
- Pregnancy, breastfeeding, planning pregnancy, or refusal to use contraceptives
- Metastatic or untreated malignant tumors
- Life expectancy less than one year
- Already implanted with medication pump or other devices
- Need for therapies or exams incompatible with implanted pulse generator
- Heavy addiction to alcohol or drugs
- Less than 50% improvement or intolerance during test period
- Inability to complete long-term online follow-ups due to hardware issues
- Unwillingness to participate
- Other conditions deemed inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants undergo spinal cord stimulation and are assigned to either precise management with remote and wireless monitoring via a mobile app or conventional management with standard follow-up care.
Daily self-assessments of pain state and monthly health condition assessments for the precise management group; conventional follow-up visits at 1, 3, and 6 months post-operative for all participants
Trial Site Locations
Total: 1 location
1
Beijing Tsinghua Chang Gung Hospital
Beijing, China
Actively Recruiting
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Research Team
Y
Yang Lu, MD
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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Published Research Related To This Trial
Management of Intractable Pain in Patients With Implanted Spinal Cord Stimulation Devices During the COVID-19 Pandemic Using a Remote and Wireless Programming System.
Yang Lu, Duo Xie, Xiaolei Zhang...
https://pubmed.ncbi.nlm.nih.gov/33363453Precise management system for chronic intractable pain patients implanted with spinal cord stimulation based on a remote programming platform: study protocol for a randomized controlled trial (PreMaSy study).
Yuanchen Cheng, Duo Xie, Yan Han...
https://pubmed.ncbi.nlm.nih.gov/37691092