Different Amounts of Moxibustion in the Treatment of DPN: A Clinical RCT Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain; Diabetic Peripheral Neuropathy; Randomized Controlled Trial; Moxibustion
• Intervention / Treatment: Other: Moxibustion

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The Third Affiliated hospital of Zhejiang Chinese Medical University
    • Hangzhou, Zhejiang, China, 310000
      • Zhejiang Greentown Cardiovascular Hospital
    • Hangzhou, Zhejiang, China, 310000
      • The First Affiliated Hospital of Zhejiang Chinese Medicine University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moxibustion 15 minutes group; The selected acupoints of moxibustion are Zusanli(ST 36), Sanyinjiao(SP 6), Quchi(LI 11) and Kunlun(BL 60), moxa cones were pasted on the acupoints and moxibustion was applied by ignition, each time for 15 minutes at each acupoint, once every three days, twice a week, four consecutive weeks of treatment.	Other: Moxibustion; The recruited patients all received diabetes mellitus education. Patients with combined hypertension and hyperlipidemia received daily treatment to lower their blood pressure and blood lipids. The medication was based on their current self-medication, to keep their conditions under normal control. The drug treatment group received mecobalamin tablets and epalrestat orally for four weeks along with their daily treatment. Moxibustion 15-minute group: The selected acupoints of moxibustion are Zusanli(ST 36), Sanyinjiao(SP 6), Quchi(LI 11), and Kunlun(BL 60), moxa cones were pasted on the acupoints and moxibustion was applied by ignition, each time for 15 minutes at each acupoint, once every three days, twice a week, four consecutive weeks of treatment. The moxibustion 30-minute group except for the operating time will use the same intervention as above.
Experimental: Moxibustion 30 minutes group; The selected acupoints of moxibustion are Zusanli(ST 36), Sanyinjiao(SP 6), Quchi(LI 11) and Kunlun(BL 60), moxa cones were pasted on the acupoints and moxibustion was applied by ignition, each time for 30 minutes at each acupoint, once every three days, twice a week, four consecutive weeks of treatment.	Other: Moxibustion; The recruited patients all received diabetes mellitus education. Patients with combined hypertension and hyperlipidemia received daily treatment to lower their blood pressure and blood lipids. The medication was based on their current self-medication, to keep their conditions under normal control. The drug treatment group received mecobalamin tablets and epalrestat orally for four weeks along with their daily treatment. Moxibustion 15-minute group: The selected acupoints of moxibustion are Zusanli(ST 36), Sanyinjiao(SP 6), Quchi(LI 11), and Kunlun(BL 60), moxa cones were pasted on the acupoints and moxibustion was applied by ignition, each time for 15 minutes at each acupoint, once every three days, twice a week, four consecutive weeks of treatment. The moxibustion 30-minute group except for the operating time will use the same intervention as above.
Sham Comparator: Drug treatment group; mecobalamin tablets (0.5 mg/dose, 3 times/day) and epalrestat (0.5g/, 3 times/day, before meal) were administered orally for four weeks in conjunction with the patient's daily treatment (basal medication treatment for patients with combined hypertension and hyperlipidemia).	Other: Moxibustion; The recruited patients all received diabetes mellitus education. Patients with combined hypertension and hyperlipidemia received daily treatment to lower their blood pressure and blood lipids. The medication was based on their current self-medication, to keep their conditions under normal control. The drug treatment group received mecobalamin tablets and epalrestat orally for four weeks along with their daily treatment. Moxibustion 15-minute group: The selected acupoints of moxibustion are Zusanli(ST 36), Sanyinjiao(SP 6), Quchi(LI 11), and Kunlun(BL 60), moxa cones were pasted on the acupoints and moxibustion was applied by ignition, each time for 15 minutes at each acupoint, once every three days, twice a week, four consecutive weeks of treatment. The moxibustion 30-minute group except for the operating time will use the same intervention as above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total clinical effectiveness	Overall clinical effectiveness was assessed at 2 time points: after 4 weeks of treatment and during the follow-up period (the 6th week). It was classified into the following 3 grades according to the Guidelines for Clinical Study of New Chinese Medicines: Cure: clinical symptoms such as limb numbness, coldness and chilling pain, sensory abnormalities, muscle weakness and muscle atrophy disappear, tendon reflexes return to normal, and the total score of TCSS is ≤ 5 points;; Effective: numbness of the limbs, cold and chilling pain, sensory abnormalities, muscle weakness myasthenia and other clinical symptoms significantly improved, tendon reflexes returned to normal, TCSS score level 2 or 1 level lower;; Ineffective: clinical symptoms did not improve or worsen, tendon reflexes were not elicited, and TCSS score grade did not decrease or increase. Total effective rate = [(number of cured cases + number of effective cases)/total number of cases] × 100%.	After treatment phase (the 4th week) and the follow-up period (the 5th-8th week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrophysiological examination of the peroneal nerve of the lower limb	The latency, amplitude, motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of the peroneal nerve of the lower extremities were measured by electrophysiological examination before and after treatment.	The week 0 and the 4th week
infrared thermography testing	Infrared thermography testing will be performed once before treatment (baseline) and once after 4 weeks of treatment at 2 time points. The test sites will be bilateral plantar, dorsal, palmar, and dorsal hands. The instrument used is the NECR450 infrared thermal imager produced by NECAVIO Company in Japan.	The week 0 and the 4th week
Electrophysiological examination of the tibial nerve of the lower limb	The latency, amplitude, motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV) of the tibial nerve of the lower extremities were measured by electrophysiological examination before and after treatment.	Baseline (week 0) and the 4th week
Toronto Clinical Scoring System	The TCSS is a valid instrument to reflect the presence and severity of diabetic peripheral sensorimotor polyneuropathy as measured by sural nerve morphology and electrophysiology16. TCSS scores of 6-8 for mild DPN, 9-10 for moderate DPN, and 12-19 for sev	The week 0, the 4th week and the 5th-8th week
Visual Analogue Scale	The level of pain at the subject's lesion site will be determined using the VAS scale, which classifies pain on a scale of 0-10, with the greater the number the more pronounced the pain, i.e., a score of 0 indicates no pain, 2-4 represents mild pain, 5-7 represents moderate pain, 8-9 represents severe pain, and 10 represents severe pain. Allow the subject to indicate the level of pain by crossing out specific numbers on the scale according to their actual situation.	The week 0, the 4th week and the 5th-8th week
Traditional Chinese Medicine Syndrome Score Scale	The evaluation of the curative effect of TCM symptoms should refer to the guiding principles of clinical research of new drugs of traditional Chinese medicine and the clinical evidence-based practice guide of traditional Chinese medicine for diabetes. The specific records are as follows: 1 the VAS score of limb pain was consistent according to the severity. (2) the three main TCM syndromes of limb numbness, abnormal chill (or fever) and ant feeling were scored as 0, 1, 2 and 3 points respectively according to their severity.	The week 0, the 4th week and the 5th-8th week

Collaborators and Investigators

• Sponsor: Zhejiang Chinese Medical University
• Collaborators: The First Affiliated Hospital of Zhejiang Chinese Medical University; Zhejiang Greentown Cardiovascular Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Moxibustion; Diabetic Peripheral Neuropathy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Neuromuscular Diseases; Diabetes Mellitus; Diabetes Complications; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: YJiang

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No