Chronic pain, persistent and stubborn pain in the trunk and limbs
Conditions
Interventions
Group B:First administer open-loop SCS stimulation for one month, followed by closed-loop stimulation for one month.
Group A:First administer closed-loop SCS stimulation for one month, followed by open-loop stimulation for one month.
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients with chronic pain who have undergone at least 3 months of conservative treatment with unsatisfactory or ineffective results; 2.Visual Analog Scale (VAS) score remains consistently greater than 6 for 3 days. 3.Age >=18 years old, no gender restrictions; 4.Take pain medication consistently for at least 28 days. 5.Capable of fulfilling the requirements for follow-up and questionnaire evaluation; 6.Voluntarily participate in clinical research and be able to sign an informed consent form;
Exclusion criteria
Exclusion criteria: 1.Pregnant women, breastfeeding women, women of childbearing age who are planning to conceive or are not using reliable contraception; 2.Patients with cognitive impairment (MoCA score >=26; add 1 point if education level <=12 years), severe depression that is untreatable, or inability to cooperate with surgery and programming procedures. 3.Severe dependence on drugs, alcohol, or illegal substances; 4.Local infection or active systemic infection at the anticipated surgical site; 5.The implantation site must undergo diathermy therapy. 6.Factors affecting SCS surgery are present in the spinal cord and spine, making SCS surgery unsuitable for certain patients. 7.An implantable drug pump and/or another implantable device, such as a pacemaker, defibrillator, cochlear implant, or other neurostimulator, has been placed. 8.Bleeding complications or coagulation disorders; 9.Metastatic malignant tumors or untreated localized malignant tumors; 10.Life expectancy is less than one year. 11.Unwilling or unable to cooperate with postoperative follow-up; 12.Researchers deem it inapplicable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in pain compared to preoperative levels; | — |
Secondary
| Measure | Time frame |
|---|---|
| Programmed Control and Neurophysiological Characteristics;Pain medication dosage;Excessive stimulation intensity;Sleep Assessment; | — |
Countries
China
Contacts
Public ContactLiqiang Yang
Xuanwu Hospital Capital Medical University
Outcome results
None listed