NCT05761392 APP-based Precise Management System of Chronic Intractable Pain
| NCT ID | NCT05761392 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tsinghua Chang Gung Hospital |
| Condition | Pain, Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-09-26 |
| Primary Completion | 2026-09-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2022-09-26 with a primary completion date of 2026-09-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Yang Lu, MD
PRINCIPAL INVESTIGATOR
Beijing Tsinghua Chang Gung Hospital
Frequently Asked Questions
Who can join the NCT05761392 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pain, Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05761392 currently recruiting?
Yes, NCT05761392 is actively recruiting participants. Contact the research team at lya02121@btch.edu.cn for enrollment information.
Where is the NCT05761392 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05761392 clinical trial?
NCT05761392 is sponsored by Beijing Tsinghua Chang Gung Hospital. The principal investigator is Yang Lu, MD at Beijing Tsinghua Chang Gung Hospital. The trial plans to enroll 120 participants.