ITMCTR1900002426尚未招募未知
Multimodal brain imaging study for the improvement of cerebral central sensitization in PDPN patients by electroacupuncture of 'Adjusting internal organs and dredging channel'
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Basic Science
入排标准
- 年龄范围
- 55 至 65（—）
- 性别
- All
入选标准
- •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.
排除标准
- •(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.
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