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Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral Neuropathy

Primary Purpose

Diabetic Peripheral Neuropathic Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Basal therapy+EA
Basal therapy
Sponsored by
Zhejiang Chinese Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathic Pain focused on measuring Diabetic Peripheral Neuropathy, Electroacupuncture, Multi-center RCT

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 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. Exclusion Criteria: 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.

Sites / Locations

  • the Third affiliated hospital of Zhejiang Chinese Medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

EA group

Waiting list group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Sensory conduction velocity of superficial peroneal nerve
Sensory conduction velocity of sural nerve
Motor conduction velocity of Peroneal nerve
Motor conduction velocity of tibial nerve

Secondary Outcome Measures

Overall clinical effectiveness rate
Total effective rate = [(number of cured cases + number of effective cases)/total number of cases ] × 100%.
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.
TCM syndromes efficacy score scale
TCM syndromes efficacy score is 42, ranging from 0 (least severe) to 42 (most severe).
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
Regional temperatures of instep
Before and after treatment, the temperature of the instep will be measured using an infrared thermal imager
Regional temperatures of palm
Before and after treatment, the regional temperature of the palm will be measured using an infrared thermal imager.
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.
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.
Glycated haemoglobin (HbA1c)
Fasting blood glucose (FPG)
2-hour postprandial blood glucose (2hPG)

Full Information

First Posted
September 5, 2023
Last Updated
September 21, 2023
Sponsor
Zhejiang Chinese Medical University
Collaborators
The First Affiliated Hospital of Zhejiang Chinese Medical University, The Second Affiliated Hospital of Zhejiang Chinese Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT06054087
Brief Title
Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral Neuropathy
Official Title
Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral Neuropathy: a MulticentreRandomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Chinese Medical University
Collaborators
The First Affiliated Hospital of Zhejiang Chinese Medical University, The Second Affiliated Hospital of Zhejiang Chinese Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathic Pain
Keywords
Diabetic Peripheral Neuropathy, Electroacupuncture, Multi-center RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianqiao Fang, Ph.D,M.D
Phone
86-13606707532
Email
fangjianqiao7532@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Sun, Ph.D
Phone
86-13429610268
Email
sunjing0268@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianqiao Fang, Ph.D,M.D
Organizational Affiliation
Zhejiang Chinese Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Third affiliated hospital of Zhejiang Chinese Medical university
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Luo
Phone
86-15083521014
Email
921941696@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31518657
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.
Results Reference
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32345662
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.
Results Reference
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PubMed Identifier
27999003
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.
Results Reference
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PubMed Identifier
29709457
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.
Results Reference
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PubMed Identifier
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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.
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Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral Neuropathy

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