Effect of Transcutaneous Electrical Nerve Stimulation in Diabetic Neuropathy

July 29, 2021 updated by: Arieh Roldán Mercado Sesma, Centro Universitario de Tonalá

Effect of Transcutaneous Electrical Nerve Stimulation on Pain percepción and Serum Inflammatory Markers in Patients With Peripheral Diabetic Neuropathy

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 45425
        • University of Guadalajara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TENS
Transcutaneous electrical neurostimulation will be applied for 30 minutes three times a week during 90 days
Device: Transcutaneous electrical neurostimulation
Sessions of 30 minutes of TENS will be applied three times a week during 90 days
Sham Comparator: Sham
A sham comparator will be applied for 30 minutes three times a week during 90 days. The device does not emit electrical impulses
Device: Transcutaneous electrical neurostimulation
Sessions of 30 minutes of TENS will be applied three times a week during 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain perception
Time Frame: Change from Baseline Pain perception at 90 days
Evaluation of neuropathic pain evaluated with VAS
Change from Baseline Pain perception at 90 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Universitario de Tonalá

Collaborators

University of Guadalajara
Diabetes sin Complicaciones S.A de C.V, Mexico

Investigators

  • Principal Investigator: Arieh R Mercado Sesma, PhD, Salud Enfermedad como proceso individual, CUTonalá, Universidad de Guadalajara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

January 31, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

July 29, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TENS-ND-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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