chronic, intractable pain
Conditions
Interventions
Experimental group 1:Permanent Implant
Experimental group 2:Non-Permanent Implant
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years, no gender limit; 2. Those who have good compliance and can cooperate to complete the entire clinical trial; 3. Those who have not participated in other clinical trials within three months; 4. Patients with chronic, intractable pain; including the following diseases: (1) Herpes zoster-related pain (including subacute and postherpetic neuralgia); (2) Complex regional pain (CRPS); (3) Pain after brachial plexus injury; (4) Intractable pain after lumbar spine surgery, intractable low back pain (FBSS); (5) Vascular occlusive pain (lower extremity vascular occlusion, vasculitis); (6) Ischemic pain (Raynaud's disease, diabetic foot-related pain); (7) Phantom limb pain, stump pain; (8) Pain after spinal cord injury, pain after cauda equina injury; (9) Radicular pain syndrome, arachnoiditis, dural fibrosis; (10) Intercostal neuralgia, incision pain; (11) Cauda equina pain, perineal pain; (12) Peripheral neuropathic pain; (13) Erythematous extremity pain; (14) Perineal pain; (15) Headache (occipital neuralgia, migraine, cluster headache), etc.; 5. VAS assessment of pain degree score >= 5; 6. Have a certain ability to understand and express, voluntarily participate and sign the informed consent; 7. Patients are willing to conduct follow-up evaluations in accordance with the requirements of the validation protocol.
Exclusion criteria
Exclusion criteria: 1. Subjects with hemorrhagic constitution or coagulation dysfunction (prothrombin time PT>=18s); 2. Subjects with implanted cardiac pacemakers, cardioverters or defibrillators; 3. Severe cognitive difficulties and/or difficulty in operating the instrument, making it difficult to make an exact evaluation of the effectiveness and safety of the instrument; 4. Subjects with drug abuse; 5. Subjects who need continuous electrotherapy; 6. Subjects who are judged by the investigator to be unsuitable to participate in clinical trials; 7. Subjects who are pregnant or intend to become pregnant in the past year, and breastfeeding women; 8. Those with an expected survival period of less than 1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| >=50% reduction in VAS score for pain compared to baseline at 180 days after start-up; and no increase in any pain medication compared to baseline at two weeks before the visit point; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of results of system impedance testing after surgical implantation;Change in percentage of subjects in pain (assessed by VAS) from baseline;Changes in subjects' ODI scores compared to baseline, as well as changes in neuropsychological scores;Non-permanently implanted subjects, change in percentage of subjects with pain (assessed by VAS) from baseline;Assessment of medication intake;Evaluation on operational performance of investigational equipment by subjects;Investigator's evaluation of operational performance of investigational equipment;Safety assessment - the evaluation endpoint was 180 days after power-on (for subjects with non-permanently implanted electrodes, the evaluation endpoint was 30 days after test electrode implantation); | — |
Countries
China
Contacts
Public ContactSong Tao
Outcome results
None listed