Diabetic Peripheral Neuropathy
Conditions
Keywords
Diabetic Peripheral Neuropathy, Diabetes, Electroacupuncture
Brief summary
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.
Detailed description
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.
Interventions
Temperatures and infrared thermograms were recorded in the region of the extremities of three groups of subjects by using an infrared thermographic camera.
PROCEDUREBasal therapy+EA
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.
OTHERBasal therapy
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.
Sponsors
Zhejiang Chinese Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Part Ⅰ： Inclusion criteria for healthy subjects: 1. Routine physical examination by the investigator to confirm the absence of heart and lung diseases, and the absence of serious underlying diseases such as digestive, urinary, haematological, endocrine, and neurological systems; 2. 18 years old ≤ age ≤ 85 years old, gender is not limited; 3. Have normal communication ability; 4. Those who have a sense of autonomy and independence, voluntarily submit to the study protocol and sign the informed consent form. Inclusion criteria for diabetic patients 1. 18 ≤ age ≤ 85 years old, with any disease duration and any gender; 2. Lower limb nerve electromyography shows no slowing of conduction velocity; 3. Normal communication ability; 4. No serious heart, brain, liver, kidney and other internal diseases, no serious mental illness and cognitive impairment; 5. Those who have a sense of autonomy and independence, voluntarily submit to the study protocol, and sign the informed consent form. Inclusion criteria for mild DPN patients 1. 18 years ≤ age ≤ 85 years with any disease duration and any gender; 2. Clear history of diabetes mellitus; 3. Lower limb nerve EMG showing reduced conduction velocity, and/or persistent pain and/or sensory abnormalities in the extremities (at least in both lower limbs), diminished ankle reflexes bilaterally or unilaterally, and diminished vibration sensation; 4. TCSS score of 6-8; 5. Have normal communication skills; 6. No serious heart, brain, liver, kidney and other medical disorders, no serious mental illness and cognitive impairment; 7. Those who have a sense of autonomy and independence, voluntarily submit to the study protocol, and sign the informed consent form. * Part Ⅱ： Inclusion Criteria: 1. 18 years ≤ age ≤ 85 years with any disease duration and any gender; 2. Those with changes in thermal characteristics for early warning of DPN patients according to Part Ⅰ; (3) Those whose lower limb neuromuscular electromyography shows no slowing of conduction velocity; (4) Those with normal communication skills; (5) No serious heart, brain, liver, kidney and other internal diseases, no serious mental illness and cognitive impairment; (6) Have a sense of autonomy and independence, voluntarily submit to the study protocol, and sign the informed consent form.
Exclusion criteria
* Part Ⅰ：
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temperature of the soles of the feet | Baseline, 6 weeks | 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. |
| Temperature of the instep | Baseline, 6 weeks | 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. |
| Temperature of the palm | Baseline, 6 weeks | 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. |
| Temperature of the back of the hand | Baseline, 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toronto clinical scoring system | Baseline, 6 weeks | 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. |
| Glycated haemoglobin (HbA1c) | Baseline, 6 weeks | 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. |
| Electromyogram examination-Sensory conduction velocity of superficial peroneal nerve | Baseline, 6 weeks | 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. |
| 2-hour postprandial blood glucose (2hPG) | Baseline, 6 weeks | 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. |
| Fasting blood glucose (FPG) | Baseline, 6 weeks | 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. |
| Electromyogram examination-Sensory conduction velocity of sural nerve | Baseline, 6 weeks | 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. |
| Electromyogram examination-Motor conduction velocity of Peroneal nerve | Baseline, 6 weeks | 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. |
| Electromyogram examination-Motor conduction velocity of tibial nerve | Baseline, 6 weeks | 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. |
Countries
China
Contacts
Primary ContactJianqiao Fang
Backup ContactJing Sun
Outcome results
None listed