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 is designed to provide the treatment plan for moxibustion for diabetic peripheral neuropathy (DPN) and provide a reference for clinical moxibustion for DPN. The patients will be randomly assigned to three clinical centers each center 44, then they will be distributed equally into 4 groups, which include the conventional treatment group and the moxibustion different minutes (5 minutes, 10 minutes, 15 minutes) per point group. The conventional treatment group will receive mecobalamin tablets and alpha-lipoic acid tablets for four weeks in conjunction with the patient's daily treatment (basal drug treatment for patients with combined hypertension and hyperlipidaemia). The frequency of moxibustion treatment is twice a week for 4 weeks. The outcomes were evaluated in the baseline period (the day before grouping), the treatment period (end of the 8th treatment) and the follow-up period (2 weeks after the end of treatment). The results of this study are expected to confirm the optimal amount of moxibustion for the treatment of diabetic peripheral neuralgia and to observe the efficacy of moxibustion in the treatment of diabetic peripheral neuralgia. It provides a reference for the clinical therapeutic operation standardization of moxibustion.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Diabetic Peripheral Neuropathy; Randomized Controlled Trial; Moxibustion
• Intervention / Treatment: Other: Moxibustion

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yongliang Jiang, 43; Phone Number: 13858173136; Email: jyl2182@126.com
• Study Contact Backup: Name: Kang Yurong, 28; Phone Number: 18830275382; Email: k18830275382@163.com

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;
3. TCSS score >5 (TCSS score 6-8 is mild DPN, 9-10 is moderate DPN, 12-19 is severe DPN);
4. 18 years ≤ age ≤ 80 years;
5. Gender is not limited;
6. Through basic treatment (including diabetes education, dietary control, appropriate exercise, selection of oral hypoglycemic drugs or subcutaneous insulin injection) to make the blood glucose control in fasting blood glucose < 8.0 mmol / L, postprandial blood glucose < 10.0 mmol / L, glycosylated haemoglobin < 7.0 %;
7. Those who have the ability of independent daily life and can cooperate to complete all the examinations;
8. 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;
9. Voluntary participation and signing of informed consent.

Exclusion Criteria:

1. Patients ≤ 18 years old or ≥ 80 years old;
2. 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;
3. Women who are in preparation for pregnancy, during pregnancy or breastfeeding;
4. Those with acute complications such as combined diabetic ketoacidosis, lactic acidosis, severe infections, etc.;
5. 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.);
6. Those who have scars or pigmentation on the skin of the testing site, which will affect the accuracy of the test;
7. 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Conventional treatment group; mecobalamin tablets (0.5 mg/dose, 3 times/day) and alpha-lipoic acid tablets (0.2 g/dose, 3 times/day) 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 conventional treatment group received mecobalamin tablets and alpha-lipoic acid tablets orally for four weeks along with their daily treatment. Moxibustion for 5 minutes per point group: Based on conventional treatment, moxibustion was performed. Selection of acupoints was based on data mining of preferred acupoints, moxa cones were pasted on the acupoints and moxibustion was applied by ignition, each time for 5 minutes at each acupoint, once every three days, twice a week, four consecutive weeks of treatment. Moxibustion for 10 minutes per point group and 15 minutes per point group was the same operation as Moxibustion for 5 minutes per point group apart from intervention time.
Experimental: Moxibustion 5 minutes group; Moxibustion for 5 minutes per point group: Based on conventional treatment, moxibustion was performed. Selection of acupoints was based on data mining of preferred acupoints, moxa cones were pasted on the acupoints and moxibustion was applied by ignition, each time for 5 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 conventional treatment group received mecobalamin tablets and alpha-lipoic acid tablets orally for four weeks along with their daily treatment. Moxibustion for 5 minutes per point group: Based on conventional treatment, moxibustion was performed. Selection of acupoints was based on data mining of preferred acupoints, moxa cones were pasted on the acupoints and moxibustion was applied by ignition, each time for 5 minutes at each acupoint, once every three days, twice a week, four consecutive weeks of treatment. Moxibustion for 10 minutes per point group and 15 minutes per point group was the same operation as Moxibustion for 5 minutes per point group apart from intervention time.
Experimental: Moxibustion 10 minutes group; Moxibustion for 10 minutes per point group: Based on conventional treatment, moxibustion was performed. Selection of acupoints was based on data mining of preferred acupoints, moxa cones were pasted on the acupoints and moxibustion was applied by ignition, each time for 10 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 conventional treatment group received mecobalamin tablets and alpha-lipoic acid tablets orally for four weeks along with their daily treatment. Moxibustion for 5 minutes per point group: Based on conventional treatment, moxibustion was performed. Selection of acupoints was based on data mining of preferred acupoints, moxa cones were pasted on the acupoints and moxibustion was applied by ignition, each time for 5 minutes at each acupoint, once every three days, twice a week, four consecutive weeks of treatment. Moxibustion for 10 minutes per point group and 15 minutes per point group was the same operation as Moxibustion for 5 minutes per point group apart from intervention time.
Experimental: Moxibustion 15 minutes group; Moxibustion for 15 minutes per point group: Based on conventional treatment, moxibustion was performed. Selection of acupoints was based on data mining of preferred acupoints, 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 conventional treatment group received mecobalamin tablets and alpha-lipoic acid tablets orally for four weeks along with their daily treatment. Moxibustion for 5 minutes per point group: Based on conventional treatment, moxibustion was performed. Selection of acupoints was based on data mining of preferred acupoints, moxa cones were pasted on the acupoints and moxibustion was applied by ignition, each time for 5 minutes at each acupoint, once every three days, twice a week, four consecutive weeks of treatment. Moxibustion for 10 minutes per point group and 15 minutes per point group was the same operation as Moxibustion for 5 minutes per point group apart from intervention time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 after treatment phase (the 4th week)
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

Secondary 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%.	The 4th week and the follow-up period (the 6th 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 6th 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 6th 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 6th week
regional temperature testing	Area temperature testing will be performed before and after each operation. Using an infrared thermometer, the temperature of the area of the acupuncture point will be detected before the moxibustion operation; immediately after moxibustion, the temperature of the corresponding acupuncture point area will be detected again.	Treatment twice a week for 4 weeks during the treatment period, and the local acupoint temperature was measured after each treatment up to 4 weeks
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 7, 2024
• 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 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Moxibustion; Diabetic Peripheral Neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; 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