Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral Neuropathy

September 21, 2023 updated by: Jianqiao Fang, Zhejiang Chinese Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • the Third Affiliated Hospital of Zhejiang Chinese Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EA group
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
  1. 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.
  2. 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.
Other: Waiting list group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensory conduction velocity of superficial peroneal nerve
Time Frame: Baseline, 6 weeks
Baseline, 6 weeks
Sensory conduction velocity of sural nerve
Time Frame: Baseline, 6 weeks
Baseline, 6 weeks
Motor conduction velocity of Peroneal nerve
Time Frame: Baseline, 6 weeks
Baseline, 6 weeks
Motor conduction velocity of tibial nerve
Time Frame: Baseline, 6 weeks
Baseline, 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall clinical effectiveness rate
Time Frame: 3 weeks, 6 weeks, 10 weeks
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）
Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks
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
Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks
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
Time Frame: Baseline, 6 weeks
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
Time Frame: Baseline, 6 weeks
Before and after treatment, the temperature of the instep will be measured using an infrared thermal imager
Baseline, 6 weeks
Regional temperatures of palm
Time Frame: Baseline, 6 weeks
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
Time Frame: Baseline, 6 weeks
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)
Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks
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）
Time Frame: Baseline, 6 weeks
Baseline, 6 weeks
Fasting blood glucose (FPG)
Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks
Baseline, 3 weeks, 6 weeks, 10 weeks
2-hour postprandial blood glucose (2hPG)
Time Frame: Baseline, 3 weeks, 6 weeks, 10 weeks
Baseline, 3 weeks, 6 weeks, 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Chinese Medical University

Collaborators

The First Affiliated Hospital of Zhejiang Chinese Medical University
The Second Affiliated Hospital of Zhejiang Chinese Medical University

Investigators

  • Principal Investigator: Jianqiao Fang, Ph.D,M.D, Zhejiang Chinese Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZY-ZJ-KJ-23021-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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