Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy — EA&DPN  

Diabetic Peripheral Neuropathy Clinical Trial

Official title: Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy and Its Correlation With Nerve Conduction Changes

Status Recruiting

Clinical Trial Summary

This is a controlled clinical trial with the aim to study the effects of electroacupuncture on neuropathic pain reduction, quality of life and changes in sensory and motor nerve conduction velocity in patients with type 2 diabetes mellitus, beneficiaries of the familiar medical centers 20, 40 and 41 of the Instituto Mexicano del Seguro Social, at north of Mexico City, in colaboration with the human acupuncture specialty of the Escuela Nacional de Medicina y Homeopatía, Instituto Politécnico Nacional, Mexico.

Clinical Trial Description

Controlled clinical trial to evaluate the effect of electroacupuncture on the reduction of neuropathic pain, quality of life; electrophysiological, inflammatory response, oxidative stress, and genetic expression, in patients with type 2 diabetes mellitus, beneficiaries from the family medical centers 20 , 40 and 41 of the Instituto Mexicano del Seguro Social, at north of Mexico City.

Once the acceptance letter has been signed, a series of questionnaires (MNSI, MDNS, DN-4, NRS, and SF-36), and a physical examination will be carried out to meet the necessary criteria to continue participating.

Only candidates with clinical diagnosis of diabetic polyneuropathy will have an electrophysiological examination by nerve conduction velocity study, if so, patients will be randomized to the electroacupunture or sham acupuncture groups.

Before intervention, laboratory studies will be taken after fasting for 8 to 10 hours, to determine biochemichal profile (glucose, urea, creatinine, uric acid , triglycerides, total cholesterol, HDL and LDL), oxidative stress (Malondialdehyde), inflammatory response (IL-6, IL1β, TNF-α, IL-10 and IL-18 cytokines), and gene expression (5-HT1AR, Neurokinin 1, α-adrenoreceptors, NGF, CX3CR1, GAP-43, and NT3).

Intervention will be applied in a total of 32 acupuncture sessions, divided into two intervention cycles, that is, 16 sessions over two months, with a rest period of one month in between.

At the end of both cycles of interventions, the questionnaires, the nerve conduction velocity study the biochemical and molecular studies will be re-assessed. Finally, this will be re-evaluated after three months post-intervention in order to evaluate the effect of intervention over time. ;

Related Conditions & MeSH terms

• Acupuncture
• Diabetic Neuropathies
• Diabetic Peripheral Neuropathic Pain
• Diabetic Peripheral Neuropathy
• Diabetic Polyneuropathy
• Electroacupuncture
• Nerve Conduction
• Neuralgia
• Peripheral Nervous System Diseases
• Polyneuropathies

• NCT number: NCT05521737
• Study type: Interventional
• Source: Instituto Mexicano del Seguro Social
• Contact: José de Jesús Peralta Romero, PhD
• Phone: 5532318563
• Email: drjjperalta@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Completion date: December 2025