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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
104
1. 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. 2. Main acupoints: Qihai (RN6), Guanyuan (RN4), Xuehai (SP10), Yanglingquan (GB34), Zusanli (T36), Yinlingquan (SP9), Sanyinjiao (SP6), Xuanzhong (GB39), Jiexi (ST41), Zulinqi (GB41), Taichong (SP41). Supporting acupoints: for pain in the upper limbs, add Baxie, Quchi (LI11), Shousanli (LI10), Hegu (LI4), and Ashixue; for pain in the lower limbs, add Bafeng, Neiting (ST44),Kunlun (BL60). Operation: Acupuncture needles of size 25\*40mm will be used. The electrode will be connected Yanglingquan (GB34) and Sanyinjiao (SP6), electrode wire will be connected to the electro-acupuncture apparatus using continuous wave with a frequency of 2Hz at an intensity suitable for the comfort of the subject.
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.
the Third affiliated hospital of Zhejiang Chinese Medical university
Hangzhou, Zhejiang, China
Sensory conduction velocity of superficial peroneal nerve
Time frame: Baseline, 6 weeks
Sensory conduction velocity of sural nerve
Time frame: Baseline, 6 weeks
Motor conduction velocity of Peroneal nerve
Time frame: Baseline, 6 weeks
Motor conduction velocity of tibial nerve
Time frame: Baseline, 6 weeks
Overall clinical effectiveness rate
Total effective rate = \[(number of cured cases + number of effective cases)/total number of cases \] × 100%.
Time frame: 3 weeks, 6 weeks, 10 weeks
Toronto clinical scoring system(TCSS)
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.
Time frame: 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).
Time frame: 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
Time frame: Baseline, 6 weeks
Regional temperatures of instep
Before and after treatment, the temperature of the instep will be measured using an infrared thermal imager
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 weeks, 6 weeks, 10 weeks
Glycated haemoglobin (HbA1c)
Time frame: Baseline, 6 weeks
Fasting blood glucose (FPG)
Time frame: Baseline, 3 weeks, 6 weeks, 10 weeks
2-hour postprandial blood glucose (2hPG)
Time frame: Baseline, 3 weeks, 6 weeks, 10 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.