Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06054087
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-26
First Post:
2023-09-05
Brief Title:
Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral Neuropathy
Sponsor:
Zhejiang Chinese Medical University
Organization:
Zhejiang Chinese Medical University
Study Overview
Official Title:
Effectiveness of Electroacupuncture in the Treatment of Diabetic Peripheral Neuropathy a MulticentreRandomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 systemTCSS 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None