Multimodal brain imaging study for the improvement of cerebral central sensitization in PDPN patients by electroacupuncture of 'Adjusting internal organs and dredging channel'
- Conditions
- Painful diabetic peripheral neuropathy (PDPN)
- Registration Number
- ITMCTR1900002426
- Lead Sponsor
- Changchun University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. DM and PDPN inclusion criteria
(1) Meet the clinical diagnostic criteria of PDPN;
(2) Aged 55 to 65 years;
(3) Vital signs were stable, blood pressure and heart rate were normal;
(4) Normal cognitive ability and expression ability, no serious cardiovascular and cerebrovascular diseases;
(5) No other peripheral nervous system lesions.
(6) Signed the informed consent form, volunteered to participate in this study, and was able to cooperate with doctors to complete the clinical study.
2. DM without PDPN:
(1) Fasting blood glucose (forbidden calorie intake for at least 8h) =7.0mmol/L;
(2) No PDPN symptoms.
(3) Aged 55 to 65 years;
(4) CPT negative;
(5) Signed the informed consent form, volunteered to participate in this study, and was able to cooperate with doctors to complete the clinical study.
3. Healthy subjects:
(1) Aged 55 to 65, moderate size.
(2) No religious belief, no tobacco, alcohol, coffee, tea and other bad habits.
(3) No work pressure or life pressure during the observation period.
(4) Physical health, cardiovascular cerebrovascular disease and other organic diseases.
(5) CPT negative;
(6) Signed the informed consent form, volunteered to participate in this study, and was able to cooperate with doctors to complete the clinical study.
(1) Sensitive to acupuncture;
(2) Patients with severe diabetic complications (such as proliferative retinopathy, diabetic nephropathy, disappearance of dorsal foot artery fluctuations, etc.);
(3) Patients with severe primary diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, as well as patients with autoimmune diseases, hyperthyroidism and other diseases affecting blood glucose;
(4) Neuropathy caused by other factors (such as genetics, trauma, alcoholism, drug intoxication, hypothyroidism, etc);
(5) Patients who had recently used corticosteroids;
(6) Participants in other or similar clinical trials within the last 3 months;
(7) Bleeding tendency or bleeding occurred within 1 month;
(8) Having drug, alcohol or drug dependence;
(9) Severe mental illness;
(10) Patients with implanted metals, such as pacemakers, defibrillators, cardiac stents, artificial heart valves, metal clips after aneurysm surgery, drug perfusion devices, nerve stimulators, bone growth stimulators and any other types of biological stimulators, metal suture, etc.Patients with bullets, broken shrapnel or screws in the body, or patients with fixed plates, screws and screws in the body after fracture;Patients with artificial limbs or joints, penile prostheses, hearing AIDS, cochlear implants, middle ear implants, metal foreign bodies in the eyes, artificial eyes and implants in the head and face, etc.;
(11) Patients with claustrophobia;
(12) The degree of pain is severe, which is continuous severe pain with changes in blood pressure and pulse.
Study & Design
- Study Type
- Basic Science
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensory nerve Conduction Velocity;Current Perception Threshold;functional Magenetic Resonance Imaging;
- Secondary Outcome Measures
Name Time Method ow-density Lipoprotein;Glycated albumin;High-density Lipoprotein;Triglyceride;Serum c-peptide;Total Cholesterol;