NCT05521737

Effect of Electroacupuncture on Sensitive Symptoms of Distal Diabetic Peripheral Neuropathy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Instituto Mexicano del Seguro Social · Other Government
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Electroacupuncture
• Acupuncture
• Diabetic Polyneuropathy
• Diabetic Peripheral Neuropathy
• Diabetic Peripheral Neuropathic Pain
• Nerve Conduction

Interventions

Type	Name	Description
PROCEDURE	Electroacupuncture	Intervention consists of a total of 32 sessions, divided into two intervention cycles, that is, 16 sessions over two months, with a rest period of one month in between. EA is applied for 20 minutes at an alternating frequency of 2 Hz. Acupunctural points are Zusanli (E36), Fenlong (E40), Yinlingquan (B9), Sanyinjiao (B6), Taichong (H3) and Zulinqi (VB41).
PROCEDURE	Sham Acupuncture	Intervention consists of a total of 32 sessions, divided into two intervention cycles, that is, 16 sessions over two months, with a rest period of one month in between. Sham acupuncture will be applied using a nonpuncture device without electrical stimulation at the same acupunctural points as in the EA group.

Timeline

• Start date: 2021-11-01
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2022-08-30
• Last updated: 2024-05-22

Locations

1 site across 1 country: Mexico