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

Instituto Mexicano del Seguro Social

Status: Enrolling

Conditions: Diabetic Peripheral Neuropathic Pain; Nerve Conduction; Acupuncture; Diabetic Polyneuropathy; Electroacupuncture; Diabetic Peripheral Neuropathy

Treatments: Procedure: Electroacupuncture; Procedure: Sham Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05521737

17 CI 09 015 006 (Other Identifier)

09-CEI-009-20160601 (Other Identifier)

R-2020-785-070

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 2 diabetes.
• Patients with clinical diabetic peripheral polyneuropathy.
• Patients with electrophysiological diagnosis of diabetic peripheral polyneuropathy in its different types of classification.

Exclusion criteria

• Type 1 Diabetes or gestational diabetes.
• Systemic autoimmune diseases.
• Hematological disorders.
• HIV diagnosis.
• Cancer in treatment.
• Pregnancy.
• Other types of neurological disorders or neuropathies.
• Intervention with acupuncture six months previously.
• Patients with pacemarkers.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Sham group

Sham Comparator group

Description:

Sham acupuncture will be administered in a total of 32 sessions within five months.

Treatment:

Procedure: Sham Acupuncture

Interventional group

Experimental group

Description:

Electroacupuncture will be administered in a total of 32 sessions within five months.

Treatment:

Procedure: Electroacupuncture