Effect of Transcutaneous Electrical Nerve Stimulation in Diabetic Neuropathy

Phase 3

Terminated

• Conditions: Diabetic Neuropathy Peripheral
• Interventions: Device: Transcutaneous electrical neurostimulation

• Registration Number: NCT04253860
• Lead Sponsor: Centro Universitario de Tonalá

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-01-31
• Study First Posted: 2020-02-05
• Primary Completion: 2020-09-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-29
• Study Completion: 2021-07-30
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Transcutaneous electrical neurostimulation	A sham comparator will be applied for 30 minutes three times a week during 90 days. The device does not emit electrical impulses
TENS	Transcutaneous electrical neurostimulation	Transcutaneous electrical neurostimulation will be applied for 30 minutes three times a week during 90 days

Primary Outcome Measures

Name	Time	Method
Pain perception	Change from Baseline Pain perception at 90 days	Evaluation of neuropathic pain evaluated with VAS

Secondary Outcome Measures

Name	Time	Method
Tumoral Necrosis Factor Alpha	Change from Baseline serum levels of TNF-alpha at 90 days	Serum levels of TNF-alpha
C Reactive Protein ultra-sensible	Change from Baseline serum levels of CRP-us at 90 days	Serum levels of CRP-us
Interleukin-6	Change from Baseline serum levels of IL-6 at 90 days	Serum levels of IL-6

Trial Locations

Locations (1)

University of Guadalajara; 🇲🇽 Guadalajara, Jalisco, Mexico