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Recruiting
NCT05761392
APP-based Precise Management System of Chronic Intractable Pain
Conditions: Pain, Chronic, Pain, Intractable
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 120
Sponsor: Beijing Tsinghua Chang Gung Hospital
Location: China
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.
Source: ClinicalTrials.gov (NCT05761392). StuddyBuddy aggregates publicly available trial information.