Effect of Transcutaneous Electrical Nerve Stimulation in Diabetic Neuropathy

Study Overview
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Brief Summary
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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

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

Conditions
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Diabetic Neuropathy Peripheral

Intervention / Treatment
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* Device: Transcutaneous electrical neurostimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TENS<br>Transcutaneous electrical neurostimulation will be applied for 30 minutes three times a week during 90 days | Device: Transcutaneous electrical neurostimulation<br>* Sessions of 30 minutes of TENS will be applied three times a week during 90 days<br>|
| Sham Comparator: Sham<br>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<br>* Sessions of 30 minutes of TENS will be applied three times a week during 90 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perception | 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 | Serum levels of TNF-alpha | Change from Baseline serum levels of TNF-alpha at 90 days | 
| Interleukin-6 | Serum levels of IL-6 | Change from Baseline serum levels of IL-6 at 90 days | 
| C Reactive Protein ultra-sensible | Serum levels of CRP-us | Change from Baseline serum levels of CRP-us at 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic neuropathy peripheral, diabetic complications, TENS, Neuropathic treatments