Diabetic Peripheral Neuropathy
Conditions
Interventions
Group A:Conventional treatment: patients will receive conventional treatment, including oral hypoglycemic agents or subcutaneous insulin injections for glycemic control
mecobalamin, B-complex vitamins, and other agents for nerve repair
Chinese herbal medicines to tonify Qi, promote blood circulation, resolve blood stasis, and unblock the collaterals to improve microcirculation
antidepressants and anticonvulsants to relieve neuropathic pain
and health education regarding diabetic complications. No TCM appropriate-technology interventions will be administered during the intervention period.
Group B:Conventional treatment plus auricular acupoint holographic Gua Sha
Group C:Conventional treatment plus Tangluoning acupoint application
Group D:Conventional treatment plus auricular acupoint holographic Gua Sha plus Tangluoning acupoint application
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meet the Western medicine diagnostic criteria for diabetes mellitus (DM) and diabetic peripheral neuropathy (DPN);Diagnostic criteria were based on the Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2024 Edition) issued by the Chinese Diabetes Society (CDS).Diagnostic Criteria for Diabetes Mellitus (DM): Patients must present with typical symptoms of diabetes (polydipsia, polyuria, polyphagia, and unexplained weight loss) and meet any one of the following criteria:1)Random plasma glucose = 11.1 mmol/L;2)Fasting plasma glucose (FPG) = 7.0 mmol/L;3)2-hour plasma glucose = 11.1 mmol/L during an Oral Glucose Tolerance Test (OGTT);4)Glycated hemoglobin (HbA1c) = 6.5%. Diagnostic Criteria for Diabetic Peripheral Neuropathy (DPN):The diagnosis of DPN is established if at least 2 out of the following 5 criteria are met:1)A definite history of diabetes mellitus.2)The presence of neuropathy (predominantly peripheral) diagnosed at the time of or after the diagnosis of diabetes.3)The presence of clinical symptoms (numbness, pain, paresthesia) and signs (diminished or absent tendon reflexes; decreased or absent vibration sense; and varying degrees of impairment in tactile, temperature, pinprick, and pressure sensation).4)Exclusion of neuropathies caused by other etiologies.5)Electromyography (EMG) may be performed to confirm the diagnosis if the above examinations are inconclusive. (2) Meet the Traditional Chinese Medicine (TCM) pattern-differentiation criteria for the Qi-deficiency and blood-stasis pattern; (3) Aged 18–80 years (inclusive), either sex; receiving regular diabetes treatment with relatively stable glycemic control (fasting plasma glucose between 4.4 and 10.0 mmol/L within the past 3 months, and HbA1c < 8.5%); (4) Voluntarily agree to participate in the study and sign written informed consent; (5) Have good adherence and are able to cooperate with treatment (able to complete the 4-week treatment as specified in the study protocol).
Exclusion criteria
Exclusion criteria: (1) Neuropathy caused by other etiologies; (2) Contraindications to Gua Sha, or severe lower-extremity ulceration or gangrene; (3) Unable to cooperate with treatment, or with psychiatric disorders; (4) Serious diabetes-related complications, such as diabetic ketoacidosis, hyperosmolar hyperglycemic coma, or severe infection; (5) Severe diseases of major organ systems (e.g., cardiovascular, cerebrovascular, pulmonary, hepatic, splenic, or renal), or organic pathology such as malignancy; (6) Allergy to Tangluoning used in this study, or skin intolerance; (7) Any other condition for which the investigator deems the participant unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TCM symptom score;Toronto Clinical Scoring System; | — |
Secondary
| Measure | Time frame |
|---|---|
| Electromyography ; | — |
Countries
China
Contacts
Public ContactYan Bai
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed