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| Name | Class |
|---|---|
| The First Affiliated Hospital of Zhejiang Chinese Medical University | OTHER |
| The Second Affiliated Hospital of Zhejiang Chinese Medical University | OTHER |
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Diabetic Peripheral Neuropathy (DPN) is one of the most common chronic complications of diabetes mellitus, which mainly manifests symmetric pain, numbness, ankylosis, or with abdominal distension, abnormal sweating, and accompanied by glove-sock-like hyperalgesia or loss of sensation as the main symptom, which seriously affects the quality of life of patients. Although drug treatment has some effect, from the overall long-term perspective, long-term medication is easy to produce drug dependence, and often easy to cause ataxia, blurred vision, constipation, diplopia, nausea and other adverse drug reactions. Electroacupuncture treatment for DPN has certain advantages, with clear efficacy and no toxic side effects, and is being increasingly recognised by the public and professionals. The study is designed to observe the therapeutic effect and safety of electroacupuncture (EA) in the treatment of DPN.
A total of 104 subjects with DPN who meet the inclusion criteria will be included in the study. Subjects will be classified as mild, moderate and severe in terms of severity by using the toronto clinical scoring system(TCSS), and subsequently randomised into the EA group and the waiting list group by using a central randomisation system. The indexes of main outcome evaluation are: sensory nerve conduction velocity (SNCV) and motor nerve conduction velocity (MNCV) of the tibial and peroneal nerves of the lower extremities. The indexes of secondary outcome evaluation are: 1) Overall clinical effectiveness rate; 2) TCSS score; 3) Chinese medicine symptom score; 4) patient's global impression of change (PGIC); 5) regional temperature test; and 6) laboratory tests (glycosylated haemoglobin, fasting blood glucose, and postprandial 2h blood glucose). This study will evaluate the effectiveness of EA in treating DPN and assess the difference in the efficacy of EA in treating patients with DPN of different severity, as well as explore the feasibility of regional temperature as an indicator for assessing the efficacy of DPN. And based on the results, a standardised, effective and convenient EA treatment protocol will be established for promotion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EA group | Experimental | Subjects in this group received electroacupuncture along with the basic treatment at a frequency of 2 treatments per week for 6 weeks for a total of 12 interventions. The follow-up period is one month. |
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| Waiting list group | Other | The subjects in this group will receive only basal treatment with no additional therapies during the study period. After the end of the study period, patients were given 12 acupuncture treatments |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basal therapy+EA | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensory conduction velocity of superficial peroneal nerve | Baseline, 6 weeks | |
| Sensory conduction velocity of sural nerve | Baseline, 6 weeks | |
| Motor conduction velocity of Peroneal nerve | Baseline, 6 weeks | |
| Motor conduction velocity of tibial nerve | Baseline, 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall clinical effectiveness rate | Total effective rate = [(number of cured cases + number of effective cases)/total number of cases ] × 100%. | 3 weeks, 6 weeks, 10 weeks |
| Toronto clinical scoring system(TCSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianqiao Fang, Ph.D,M.D | Contact | 86-13606707532 | fangjianqiao7532@163.com | |
| Jing Sun, Ph.D | Contact | 86-13429610268 | sunjing0268@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianqiao Fang, Ph.D,M.D | Zhejiang Chinese Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Third affiliated hospital of Zhejiang Chinese Medical university | Hangzhou | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31518657 | Background | Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10. | |
| 32345662 |
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| Basal therapy | Other | Participants are not set up with uniform medication. High blood sugar is controlled by hypoglycaemic drugs, patients with hypertension and hyperlipidaemia can take antihypertensive and lipid-lowering drugs, while other drugs are based on the patient's current medication. |
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The scale is an assessment of foot sensation and has a total score of 19, divided into three sections: symptom score of 6, reflex score of 8 and sensory score of 5. Symptom score: 0 = absent, 1 = present; reflex score: 0 = normal, 1 = diminished, 2 = absent; sensory score: 0 = normal, 1 = abnormal.
| Baseline, 3 weeks, 6 weeks, 10 weeks |
| TCM syndromes efficacy score scale | TCM syndromes efficacy score is 42, ranging from 0 (least severe) to 42 (most severe). | Baseline, 3 weeks, 6 weeks, 10 weeks |
| Regional temperatures of sole of the foot | Before and after treatment, the temperature of the sole of the foot will be measured using an infrared thermal imager | Baseline, 6 weeks |
| Regional temperatures of instep | Before and after treatment, the temperature of the instep will be measured using an infrared thermal imager | Baseline, 6 weeks |
| Regional temperatures of palm | Before and after treatment, the regional temperature of the palm will be measured using an infrared thermal imager. | Baseline, 6 weeks |
| Regional temperatures of back of the hand | Before and after treatment, the regional temperature of the back of the hand will be measured using an infrared thermal imager. | Baseline, 6 weeks |
| Patient Global Impression of Change(PGIC) | PGIC is scored on a 7-point scale, with higher scores representing poorer efficacy. a score of 1 indicates that the subject perceives a great improvement in efficacy, 4 is no change before and after acupuncture treatment, and 7 is much worse after treatment. | Baseline, 3 weeks, 6 weeks, 10 weeks |
| Glycated haemoglobin (HbA1c) | Baseline, 6 weeks |
| Fasting blood glucose (FPG) | Baseline, 3 weeks, 6 weeks, 10 weeks |
| 2-hour postprandial blood glucose (2hPG) | Baseline, 3 weeks, 6 weeks, 10 weeks |
| Background |
| Li Y, Teng D, Shi X, Qin G, Qin Y, Quan H, Shi B, Sun H, Ba J, Chen B, Du J, He L, Lai X, Li Y, Chi H, Liao E, Liu C, Liu L, Tang X, Tong N, Wang G, Zhang JA, Wang Y, Xue Y, Yan L, Yang J, Yang L, Yao Y, Ye Z, Zhang Q, Zhang L, Zhu J, Zhu M, Ning G, Mu Y, Zhao J, Teng W, Shan Z. Prevalence of diabetes recorded in mainland China using 2018 diagnostic criteria from the American Diabetes Association: national cross sectional study. BMJ. 2020 Apr 28;369:m997. doi: 10.1136/bmj.m997. |
| 27999003 | Background | Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available. |
| 29709457 | Background | Iqbal Z, Azmi S, Yadav R, Ferdousi M, Kumar M, Cuthbertson DJ, Lim J, Malik RA, Alam U. Diabetic Peripheral Neuropathy: Epidemiology, Diagnosis, and Pharmacotherapy. Clin Ther. 2018 Jun;40(6):828-849. doi: 10.1016/j.clinthera.2018.04.001. Epub 2018 Apr 30. |
| 24322588 | Background | Zhang R, Lao L, Ren K, Berman BM. Mechanisms of acupuncture-electroacupuncture on persistent pain. Anesthesiology. 2014 Feb;120(2):482-503. doi: 10.1097/ALN.0000000000000101. |
| 28112552 | Background | Dimitrova A, Murchison C, Oken B. Acupuncture for the Treatment of Peripheral Neuropathy: A Systematic Review and Meta-Analysis. J Altern Complement Med. 2017 Mar;23(3):164-179. doi: 10.1089/acm.2016.0155. Epub 2017 Jan 23. |
| 33511675 | Background | Yu B, Li M, Huang H, Ma S, Huang K, Zhong Z, Yu S, Zhang L. Acupuncture treatment of diabetic peripheral neuropathy: An overview of systematic reviews. J Clin Pharm Ther. 2021 Jun;46(3):585-598. doi: 10.1111/jcpt.13351. Epub 2021 Jan 28. |
| 28271659 | Background | He XF, Wei JJ, Shou SY, Fang JQ, Jiang YL. Effects of electroacupuncture at 2 and 100 Hz on rat type 2 diabetic neuropathic pain and hyperalgesia-related protein expression in the dorsal root ganglion. J Zhejiang Univ Sci B. 2017 Mar.;18(3):239-248. doi: 10.1631/jzus.B1600247. |
| 39193463 | Derived | Luo N, Zeng YC, Fu BT, Low JW, Fang JQ. Investigating the Effectiveness of Electroacupuncture for Diabetic Peripheral Neuropathy and Exploring the Feasibility of Infrared Thermography as an Efficacy Assessment Tool: Study Protocol for a Randomized Controlled Trial. J Pain Res. 2024 Aug 23;17:2727-2739. doi: 10.2147/JPR.S472648. eCollection 2024. |