Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06054087
• Other study ID #: GZY-ZJ-KJ-23021-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Zhejiang Chinese Medical University
• Contact: Jianqiao Fang, Ph.D,M.D
• Phone: 86-13606707532
• Email: fangjianqiao7532[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: December 31, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Peripheral Neuropathic Pain
• Neuralgia
• Peripheral Nervous System Diseases

Intervention

Procedure:
• Basal therapy+EA
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. 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:
• 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.

Locations

Country	Name	City	State
China	the Third affiliated hospital of Zhejiang Chinese Medical university	Hangzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Zhejiang Chinese Medical University	The First Affiliated Hospital of Zhejiang Chinese Medical University, The Second Affiliated Hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory conduction velocity of superficial peroneal nerve		Baseline, 6 weeks
Primary	Sensory conduction velocity of sural nerve		Baseline, 6 weeks
Primary	Motor conduction velocity of Peroneal nerve		Baseline, 6 weeks
Primary	Motor conduction velocity of tibial nerve		Baseline, 6 weeks
Secondary	Overall clinical effectiveness rate	Total effective rate = [(number of cured cases + number of effective cases)/total number of cases ] × 100%.	3 weeks, 6 weeks, 10 weeks
Secondary	Toronto clinical scoring system(TCSS)	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
Secondary	TCM syndromes efficacy score scale	TCM syndromes efficacy score is 42, ranging from 0 (least severe) to 42 (most severe).	Baseline, 3 weeks, 6 weeks, 10 weeks
Secondary	Regional temperatures of sole of the foot	Before and after treatment, the temperature of the sole of the foot will be measured using an infrared thermal imager	Baseline, 6 weeks
Secondary	Regional temperatures of instep	Before and after treatment, the temperature of the instep will be measured using an infrared thermal imager	Baseline, 6 weeks
Secondary	Regional temperatures of palm	Before and after treatment, the regional temperature of the palm will be measured using an infrared thermal imager.	Baseline, 6 weeks
Secondary	Regional temperatures of back of the hand	Before and after treatment, the regional temperature of the back of the hand will be measured using an infrared thermal imager.	Baseline, 6 weeks
Secondary	Patient Global Impression of Change(PGIC)	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
Secondary	Glycated haemoglobin (HbA1c)		Baseline, 6 weeks
Secondary	Fasting blood glucose (FPG)		Baseline, 3 weeks, 6 weeks, 10 weeks
Secondary	2-hour postprandial blood glucose (2hPG)		Baseline, 3 weeks, 6 weeks, 10 weeks