Clinical trial NCT06330233: Different Amounts of Moxibustion in the Treatment of DPN: A Clinical RCT Study
Official title: Construction of Key Technology and Study of the Effect Mechanism of Moxibustion in the Treatment of Diabetic Peripheral Neuropathy Based on Optimal Selection of Acupoints and Moxibustion Volume
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Pain
Moxibustion
Randomized Controlled Trial
Keywords: Diabetic Peripheral Neuropathy
Pain
Moxibustion
Lead sponsor: Zhejiang Chinese Medical University
Sponsor class: OTHER_GOV
Collaborators: name: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: Zhejiang Greentown Cardiovascular Hospital
First posted: 2024-03-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to provide moxibustion treatment for diabetic peripheral neuropathy (DPN) and a reference for clinical treatment of DPN moxibustion. Patients will be randomly assigned to 3 clinical centers, 30 in each center, and then equally divided into 3 groups, including a drug treatment group, a 15-minute moxibustion group, and a 30-minute moxibustion group. Patients in the drug treatment group were given mecobalamin tablets and epalrestat at the same time of daily treatment (hypertension and hyperlipidemia combined with basic drug treatment) for 4 weeks. The frequency of moxibustion was 15/30 minutes per acupoint twice a week for 4 weeks. The results were evaluated during the baseline period (the day before the grouping), the treatment period (the end of the 8th treatment), and the follow-up period (a month after the end of treatment). The results of this part are expected to confirm the therapeutic effect of moxibustion on diabetic peripheral neuropathy. The results of this part will be expected to confirm the optimal amount of moxibustion in the treatment of diabetic peripheral neuralgia and provide a reference for the standardization of clinical treatment of moxibustion.


Eligibility criteria: Inclusion Criteria:

1. History of diabetes mellitus;
2. Persistent pain and/or abnormal sensation in the extremities (at least in both lower limbs), decreased bilateral or unilateral ankle reflexes, decreased vibratory sensation (weaker in the medial ankle than in the medial tibial condyle), and decreased nerve conduction velocity on the affected side, and TCSS score \>5;
3. 18 years ≤ age ≤ 80 years;
4. Gender is not limited;
5. Those who have the ability of independent daily life and can cooperate to complete all the examinations;
6. Those who are conscious without serious mental diseases and cognitive disorders, and those who do not have serious cardiac, cerebral, hepatic, renal and other internal diseases;
7. Voluntary participation and signing of informed consent.

Exclusion Criteria:

1. Those with peripheral neuropathy, ulcers and gangrene of the limbs caused by various other reasons (e.g. hypothyroidism, alcohol, drugs, heredity, etc.), or those with a history of skin ulcers or lesions that do not heal easily;
2. Women who are in preparation for pregnancy, during pregnancy or breastfeeding;
3. Those with acute complications such as combined diabetic ketoacidosis, lactic acidosis, severe infections, etc.;
4. Those who suffer from serious liver or kidney damage or serious cardiovascular and cerebrovascular diseases (angina pectoris, myocardial infarction, multiple cerebral infarctions, cerebral haemorrhage, etc.);
5. Those who have scars or pigmentation on the skin of the testing site, which will affect the accuracy of the test;
6. Those who are participating in other acupuncture or drug clinical trials.

Primary outcomes:
measure: Total clinical effectiveness
timeFrame: After treatment phase (the 4th week) and the follow-up period (the 5th-8th week)
Secondary outcomes:
measure: Electrophysiological examination of the tibial nerve of the lower limb
timeFrame: Baseline (week 0) and the 4th week
measure: Electrophysiological examination of the peroneal nerve of the lower limb
timeFrame: The week 0 and the 4th week
measure: Toronto Clinical Scoring System
timeFrame: The week 0, the 4th week and the 5th-8th week
measure: Visual Analogue Scale
timeFrame: The week 0, the 4th week and the 5th-8th week
measure: Traditional Chinese Medicine Syndrome Score Scale
timeFrame: The week 0, the 4th week and the 5th-8th week
measure: infrared thermography testing
timeFrame: The week 0 and the 4th week
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang Chinese Medicine University
state: Zhejiang
city: Hangzhou
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Greentown Cardiovascular Hospital
state: Zhejiang
Study officials:
References: