Part Ⅰ:Infrared thermograms of four parts of the soles of the feet, dorsum of the feet, palms of the hands, and dorsum of the hands of healthy volunteers, diabetic patients, and patients with diabetic peripheral neuropathy were collected by using infrared thermography, and the patterns of change in the average temperatures of the parts of the participants in the three groups were analysed and compared by using the accompanying software. Part Ⅱ: Diabetic Peripheral Neuropathy (DPN) mainly presents with symmetrical pain,numbness, and ankylosing sensation, but reversal after diagnosis is particularly difficult. Electroacupuncture can significantly improve the function of peripheral nerves, regulate local blood flow, and reduce the inflammatory response to promote nerve regeneration, but no study has shown that electroacupuncture can effectively prevent the occurrence of DPN. Therefore, it is of great research significance to determine whether electroacupuncture has the possibility in preventing the occurrence of DPN.
Part Ⅰ: We analyse and compare the change rules of average temperature in each area of the three groups of patients, explore the correlation between the temperature in each area of mild DPN patients and the duration of the disease, age, BMI, etc., and explore the optimal prediction threshold for the occurrence of DPN, as well as its sensitivity and specificity. Part Ⅱ: A total of 50 diabetic subjects meeting the inclusion criteria will be enrolled in the study and randomised into the EA group and the waiting list group using envelope randomisation. The indexes of main outcome evaluation are: change in regional temperature. The indexes of secondary outcome evaluation are: 1) sensory nerve amplitude and conduction velocity (SNCV) of the tibial and peroneal nerves of the lower extremities, and motor nerve amplitude and conduction velocity (MNCV). 2) change in TCSS score, and 3) laboratory tests (glycated haemoglobin, fasting blood glucose, and postprandial 2h blood glucose). This study will evaluate the effectiveness of EA in preventing DPN.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
200
Temperatures and infrared thermograms were recorded in the region of the extremities of three groups of subjects by using an infrared thermographic camera.
After specialist treatment, blood glucose is managed through hypoglycemic medications or insulin. Patients with both hypertension and hyperlipidemia are prescribed antihypertensive and lipid-lowering drugs. Additional medications are determined based on the patient's current medication regimen. 2. Acupoints: Qihai (RN6), Guanyuan (RN4), Xuehai (SP10), Yanglingquan (GB34), Zusanli (T36), Yinlingquan (SP9), Sanyinjiao (SP6), Xuanzhong (GB39), Jiexi (ST41), Zulinqi (GB41), Taichong (SP41). 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.
After specialist treatment, blood glucose is managed through hypoglycemic medications or insulin. Patients with both hypertension and hyperlipidemia are prescribed antihypertensive and lipid-lowering drugs. Additional medications are determined based on the patient's current medication regimen.
the Third affiliated hospital of Zhejiang Chinese Medical university
Hanzhou, Zhejiang, China
RECRUITINGTemperature of the soles of the feet
Participants in part 1 and part 2 were tested, but participants in part 1 were tested only once at enrolment and patients in part 2 were tested once before and once after treatment.
Time frame: Baseline, 6 weeks
Temperature of the instep
Participants in part 1 and part 2 were tested, but participants in part 1 were tested only once at enrolment and patients in part 2 were tested once before and once after treatment.
Time frame: Baseline, 6 weeks
Temperature of the palm
Participants in part 1 and part 2 were tested, but participants in part 1 were tested only once at enrolment and patients in part 2 were tested once before and once after treatment.
Time frame: Baseline, 6 weeks
Temperature of the back of the hand
Participants in part 1 and part 2 were tested, but participants in part 1 were tested only once at enrolment and patients in part 2 were tested once before and once after treatment.
Time frame: Baseline, 6 weeks
Electromyogram examination-Sensory conduction velocity of superficial peroneal nerve
Participants in part 1 (except Health Volunteers)and part 2 were tested, but participants in part 1 were tested only once at enrolment and patients in part 2 were tested once before and once after treatment.
Time frame: Baseline, 6 weeks
Electromyogram examination-Sensory conduction velocity of sural nerve
Participants in part 1 (except Health Volunteers)and part 2 were tested, but participants in part 1 were tested only once at enrolment and patients in part 2 were tested once before and once after treatment.
Time frame: Baseline, 6 weeks
Electromyogram examination-Motor conduction velocity of Peroneal nerve
Participants in part 1 (except Health Volunteers)and part 2 were tested, but participants in part 1 were tested only once at enrolment and patients in part 2 were tested once before and once after treatment.
Time frame: Baseline, 6 weeks
Electromyogram examination-Motor conduction velocity of tibial nerve
Participants in part 1 (except Health Volunteers)and part 2 were tested, but participants in part 1 were tested only once at enrolment and patients in part 2 were tested once before and once after treatment.
Time frame: Baseline, 6 weeks
Toronto clinical scoring system
Participants in part 1 (except Health Volunteers)and part 2 were tested, but participants in part 1 were tested only once at enrolment and patients in part 2 were tested once before and once after treatment. 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, 6 weeks
Glycated haemoglobin (HbA1c)
Participants in part 1 (except Health Volunteers)and part 2 were tested, but participants in part 1 were tested only once at enrolment and patients in part 2 were tested once before and once after treatment.
Time frame: Baseline, 6 weeks
Fasting blood glucose (FPG)
Participants in part 1 (except Health Volunteers)and part 2 were tested, but participants in part 1 were tested only once at enrolment and patients in part 2 were tested once before and once after treatment.
Time frame: Baseline, 6 weeks
2-hour postprandial blood glucose (2hPG)
Participants in part 1 (except Health Volunteers)and part 2 were tested, but participants in part 1 were tested only once at enrolment and patients in part 2 were tested once before and once after treatment.
Time frame: Baseline, 6 weeks
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