Effect of Transcutaneous Electrical Nerve Stimulation in Diabetic Neuropathy

Centro Universitario de Tonalá

Status and phase: Terminated; Phase 3

Conditions: Diabetic Neuropathy Peripheral

Treatments: Device: Transcutaneous electrical neurostimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04253860

TENS-ND-2018

Details and patient eligibility

About

Double-blind, randomized, placebo-controlled, clinical trial. Patients with diabetic neuropathy will be randomly assigned to treatment with either TENS or TENS sham three times a week during 90 days. Clinical determinations are: pain, levesls of TNF-alpha, IL-6 and RPC-us

Enrollment: 20 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnostic of type 2 diabetes > 10 years
• Diagnostic of peripheral diabetic neuropathy less than 5 years
• HbA1C > 6.5 and < 9%
• Plasmatic glucose >140 mg/dL and lees than 350 mg/dL
• Informed consent signed

Exclusion criteria

• Use of implanted pacemaker or heart defibrillator
• Implanted brain stimulator
• History of alcohol abuse
• Use of NSAID, stereoids
• Subjects with wounds, ulcers in legs
• Subjects with hepatic, renal o neurologic diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

TENS

Experimental group

Description:

Transcutaneous electrical neurostimulation will be applied for 30 minutes three times a week during 90 days

Treatment:

Device: Transcutaneous electrical neurostimulation

Sham

Sham Comparator group

Description:

A sham comparator will be applied for 30 minutes three times a week during 90 days. The device does not emit electrical impulses

Treatment:

Device: Transcutaneous electrical neurostimulation