Chronic intractable pain
Conditions
Interventions
Treatment Group:Closed-loop stimulation is initiated after implantation of the CNS system
Control Group:Open loop stimulation is initiated after implantation of the CNS system, and then switch to closed-loop stimulation
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age >= 18 years old and = 6; (4) Those who are suitable for SCS treatment according to the clinical judgment of the investigator; (5) The painkillers used have been stably used for at least 30 days before screening; (6) ODI (Oswestry Dysfunction Index) score is 41-80 out of 100; (7) The VAS score decreased by >= 50% from the baseline during the test treatment period (if the spinal cord electrical stimulation test was performed within 3 months and the VAS score decreased by >= 50%, the test treatment could not be repeated); (8) Have a certain ability to understand and express, voluntarily participate and sign the informed consent form; (9) The subjects or their families can fully understand the therapy, have reasonable postoperative expectations, be able to fill in the subject diary correctly, have good compliance, and be able to cooperate with the completion of the entire clinical trial.
Exclusion criteria
Exclusion criteria: (1) Those who have diseases or pains in other parts that may affect the evaluation index evaluator; (2) The presence of active implants in the body, such as pacemakers, deep brain stimulators, sacral nerve stimulators, defibrillators, drug infusion pumps, cochlear implants, implantable spinal cord stimulation systems (SCS), other neurostimulators, etc. (except those that have been removed or discontinued), or passive implants that affect the stimulator system; (3) Active systemic infection or local infection at the surgical site; (4) Hemorrhagic constitution or coagulation dysfunction (prothrombin time PT >= 18s); (5) undergoing anticoagulant therapy that would prevent them from proceeding with implantation surgery; (6) There is a requirement for hyperthermia treatment at present or during the trial; (7) Those who have drug abuse; (8) Patients with psychiatric disorders (PHQ-9 scale >= 20 points) after evaluation, and are not suitable for spinal cord stimulation therapy; (9) Those who are receiving electroconvulsive therapy or transcranial magnetic stimulation therapy; (10) Those who have a history of suicide or are positive for items 2-5 of the Columbia Suicide Severity Assessment Scale (C-SSRS); (11) Those who have an expected survival time of less than 1 year; (12) Pregnant and lactating women, and patients who cannot take appropriate contraceptive measures during the test; (13) Those who have participated in other clinical trials or clinical research within three months; Those who judge that the subject has poor compliance, or is not suitable to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The experimental group was more effective in the treatment of chronic intractable pain than the control group, and there was no increase from baseline in the treatment of pain drugs in the 4 weeks prior to follow-up;Evaluation of the performance of the device by the investigator and the subject; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects whose VAS score decreased by >= 50% from baseline between experimental group and control group, and the differences between two groups were compared;Proportion of subjects with a >= 80% decrease in VAS score from baseline between treatment group and control group, and the differences between two groups were compared;Proportion of subjects with a >= 50% decrease in VAS score from baseline in all subjects;The change from baseline in JOA score between treatment group and control group, and the differences between the two groups were compared;The change in JOA score from baseline in all subjects;The change from baseline in ODI(Oswestry Disability Index) score between treatment group and control group, and the differences between the two groups were compared;The change in ODI score from baseline in all subjects;The change from baseline in PHQ-9 score between treatment group and control group, and the differences between the two groups were compared;The change in PHQ-9 score from baseline in all subjects; | — |
Countries
China
Contacts
Public ContactFan Bi Fa
China-Japan Friendship Hospital
Outcome results
None listed