Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral Neuropathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral Neuropathy: a MulticentreRandomised Controlled Trial

Conditions
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Diabetic Peripheral Neuropathic Pain

Intervention / Treatment
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* Procedure: Basal therapy+EA
* Other: Basal therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years ≤ age ≤ 85 years, disease duration is not limited, gender is not limited; Lower limb neuromuscular electromyography showing reduced conduction velocity, and/or persistent pain and/or sensory abnormalities in the extremities (at least in both lower limbs), bilateral or unilateral weakened ankle reflexes, reduced vibration sensation, and a TCSS score ≥ 6; Have normal communication skills; No serious heart, brain, liver, kidney and other internal diseases, no serious mental illness and cognitive impairment; those who voluntarily obeyed the study protocol and signed the informed consent form. Exclusion Criteria: Persons with peripheral neuropathy, ulcers and gangrene of the limbs caused by a variety of other reasons (e.g. hypothyroidism, alcohol, drugs, heredity, etc.), or persons with a history of skin ulcers or lesions that do not heal easily; Presence of serious diseases, including renal disease, cardiovascular disease, pulmonary disease, liver disease or infectious disease, or malignant tumour and serious mental illness, etc; Prior history of knee/hip replacement surgery or lower limb fracture within the past 3 months, and other conditions that may affect the assessment of neuropathy Patients who have received acupuncture or moxibustion treatment for DPN within the past 3 months; Volunteers who are participating in other interventional clinical trials; Women who are preparing for pregnancy, pregnant or breastfeeding; Those who have scars or hyperpigmentation of the skin at the testing site, which affects the accuracy of the test; Unwilling to be randomly assigned to the waiting treatment group or electroacupuncture treatment group; Chronic abuse of opioids, analgesics, illicit drugs or alcohol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EA group<br>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. | Procedure: Basal therapy+EA<br>* 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. 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.<br>|
| Other: Waiting list group<br>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 | Other: Basal therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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） | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Peripheral Neuropathy, Electroacupuncture, Multi-center RCT