Clinical trial NCT06054087: Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral Neuropathy
Official title: Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral Neuropathy: a MulticentreRandomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetic Peripheral Neuropathic Pain
Keywords: Diabetic Peripheral Neuropathy
Electroacupuncture
Multi-center RCT
Lead sponsor: Zhejiang Chinese Medical University
Sponsor class: OTHER_GOV
Collaborators: name: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: The Second Affiliated Hospital of Zhejiang Chinese Medical University
First posted: 2023-09-26
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. 18 years ≤ age ≤ 85 years, disease duration is not limited, gender is not limited;
2. 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;
3. Have normal communication skills;
4. No serious heart, brain, liver, kidney and other internal diseases, no serious mental illness and cognitive impairment;
5. those who voluntarily obeyed the study protocol and signed the informed consent form.

Exclusion Criteria:

1. 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;
2. Presence of serious diseases, including renal disease, cardiovascular disease, pulmonary disease, liver disease or infectious disease, or malignant tumour and serious mental illness, etc;
3. 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
4. Patients who have received acupuncture or moxibustion treatment for DPN within the past 3 months;
5. Volunteers who are participating in other interventional clinical trials;
6. Women who are preparing for pregnancy, pregnant or breastfeeding;
7. Those who have scars or hyperpigmentation of the skin at the testing site, which affects the accuracy of the test;
8. Unwilling to be randomly assigned to the waiting treatment group or electroacupuncture treatment group;
9. Chronic abuse of opioids, analgesics, illicit drugs or alcohol.

Primary outcomes:
measure: Sensory conduction velocity of superficial peroneal nerve
timeFrame: Baseline, 6 weeks
measure: Sensory conduction velocity of sural nerve
timeFrame: Baseline, 6 weeks
measure: Motor conduction velocity of Peroneal nerve
timeFrame: Baseline, 6 weeks
measure: Motor conduction velocity of tibial nerve
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Overall clinical effectiveness rate
timeFrame: 3 weeks, 6 weeks, 10 weeks
measure: Toronto clinical scoring system（TCSS）
timeFrame: Baseline, 3 weeks, 6 weeks, 10 weeks
measure: TCM syndromes efficacy score scale
timeFrame: Baseline, 3 weeks, 6 weeks, 10 weeks
measure: Regional temperatures of sole of the foot
timeFrame: Baseline, 6 weeks
measure: Regional temperatures of instep
timeFrame: Baseline, 6 weeks
measure: Regional temperatures of palm
timeFrame: Baseline, 6 weeks
measure: Regional temperatures of back of the hand
timeFrame: Baseline, 6 weeks
measure: Patient Global Impression of Change(PGIC)
timeFrame: Baseline, 3 weeks, 6 weeks, 10 weeks
measure: Glycated haemoglobin (HbA1c）
timeFrame: Baseline, 6 weeks
measure: Fasting blood glucose (FPG)
timeFrame: Baseline, 3 weeks, 6 weeks, 10 weeks
measure: 2-hour postprandial blood glucose (2hPG)
timeFrame: Baseline, 3 weeks, 6 weeks, 10 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Third affiliated hospital of Zhejiang Chinese Medical university
state: Zhejiang
Study officials:
affiliation: Zhejiang Chinese Medical University
name: Jianqiao Fang, Ph.D,M.D
role: PRINCIPAL_INVESTIGATOR
References:
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