Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral Neuropathy

NCT06054087 | Unknown DMC

• 1 other identifier: GZY-ZJ-KJ-23021-01
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Peripheral Neuropathic Pain

Keywords

Diabetic Peripheral Neuropathy; Electroacupuncture; Multi-center RCT

Outcome Measures

Primary Outcomes (4)

• Sensory conduction velocity of superficial peroneal nerve

  Baseline, 6 weeks

• Sensory conduction velocity of sural nerve

  Baseline, 6 weeks

• Motor conduction velocity of Peroneal nerve

  Baseline, 6 weeks

• Motor conduction velocity of tibial nerve

  Baseline, 6 weeks

Secondary Outcomes (11)

• Overall clinical effectiveness rate

  3 weeks, 6 weeks, 10 weeks

• Toronto clinical scoring system（TCSS）

  Baseline, 3 weeks, 6 weeks, 10 weeks

• TCM syndromes efficacy score scale

  Baseline, 3 weeks, 6 weeks, 10 weeks

• Regional temperatures of sole of the foot

  Baseline, 6 weeks

• Regional temperatures of instep

  Baseline, 6 weeks

Study Arms (2)

EA group

EXPERIMENTAL

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

Waiting list group

OTHER

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

Interventions

Basal therapy+EA PROCEDURE

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.

EA group

Basal therapy OTHER

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.

Waiting list group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang Chinese Medical University: lead
• The First Affiliated Hospital of Zhejiang Chinese Medical University: collaborator
• The Second Affiliated Hospital of Zhejiang Chinese Medical University: collaborator

Study Sites (1)

the Third affiliated hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, China

Location

Related Publications (9)

• Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.

  PMID: 31518657 BACKGROUND

• Li Y, Teng D, Shi X, Qin G, Qin Y, Quan H, Shi B, Sun H, Ba J, Chen B, Du J, He L, Lai X, Li Y, Chi H, Liao E, Liu C, Liu L, Tang X, Tong N, Wang G, Zhang JA, Wang Y, Xue Y, Yan L, Yang J, Yang L, Yao Y, Ye Z, Zhang Q, Zhang L, Zhu J, Zhu M, Ning G, Mu Y, Zhao J, Teng W, Shan Z. Prevalence of diabetes recorded in mainland China using 2018 diagnostic criteria from the American Diabetes Association: national cross sectional study. BMJ. 2020 Apr 28;369:m997. doi: 10.1136/bmj.m997.

  PMID: 32345662 BACKGROUND

• Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.

  PMID: 27999003 BACKGROUND

• Iqbal Z, Azmi S, Yadav R, Ferdousi M, Kumar M, Cuthbertson DJ, Lim J, Malik RA, Alam U. Diabetic Peripheral Neuropathy: Epidemiology, Diagnosis, and Pharmacotherapy. Clin Ther. 2018 Jun;40(6):828-849. doi: 10.1016/j.clinthera.2018.04.001. Epub 2018 Apr 30.

  PMID: 29709457 BACKGROUND

• Zhang R, Lao L, Ren K, Berman BM. Mechanisms of acupuncture-electroacupuncture on persistent pain. Anesthesiology. 2014 Feb;120(2):482-503. doi: 10.1097/ALN.0000000000000101.

  PMID: 24322588 BACKGROUND

• Dimitrova A, Murchison C, Oken B. Acupuncture for the Treatment of Peripheral Neuropathy: A Systematic Review and Meta-Analysis. J Altern Complement Med. 2017 Mar;23(3):164-179. doi: 10.1089/acm.2016.0155. Epub 2017 Jan 23.

  PMID: 28112552 BACKGROUND

• Yu B, Li M, Huang H, Ma S, Huang K, Zhong Z, Yu S, Zhang L. Acupuncture treatment of diabetic peripheral neuropathy: An overview of systematic reviews. J Clin Pharm Ther. 2021 Jun;46(3):585-598. doi: 10.1111/jcpt.13351. Epub 2021 Jan 28.

  PMID: 33511675 BACKGROUND

• He XF, Wei JJ, Shou SY, Fang JQ, Jiang YL. Effects of electroacupuncture at 2 and 100 Hz on rat type 2 diabetic neuropathic pain and hyperalgesia-related protein expression in the dorsal root ganglion. J Zhejiang Univ Sci B. 2017 Mar.;18(3):239-248. doi: 10.1631/jzus.B1600247.

  PMID: 28271659 BACKGROUND

• Luo N, Zeng YC, Fu BT, Low JW, Fang JQ. Investigating the Effectiveness of Electroacupuncture for Diabetic Peripheral Neuropathy and Exploring the Feasibility of Infrared Thermography as an Efficacy Assessment Tool: Study Protocol for a Randomized Controlled Trial. J Pain Res. 2024 Aug 23;17:2727-2739. doi: 10.2147/JPR.S472648. eCollection 2024.

  PMID: 39193463 DERIVED

Study Officials

• Jianqiao Fang, Ph.D,M.D

  Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianqiao Fang, Ph.D,M.D

CONTACT

86-13606707532; fangjianqiao7532@163.com

Jing Sun, Ph.D

CONTACT

86-13429610268; sunjing0268@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 26, 2023
• Study Start: October 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 31, 2025
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)