APP-based Precise Management System of Chronic Intractable Pain

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tsinghua Chang Gung Hospital

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Precise management

Treatment groups

120 Participants
are divided into 2 treatment groups