Effect of Transcutaneous Electrical Nerve Stimulation in Diabetic Neuropathy

Diabetic Neuropathy Peripheral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04253860
• Other study ID #: TENS-ND-2018
• Status: Terminated
• Phase: Phase 3
• Start date: February 1, 2019
• Est. completion date: July 30, 2021

Study information

• Verified date: July 2021
• Source: Centro Universitario de Tonalá
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: July 30, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy Peripheral
• Peripheral Nervous System Diseases

Intervention

Device:
• Transcutaneous electrical neurostimulation
Sessions of 30 minutes of TENS will be applied three times a week during 90 days

Locations

Country	Name	City	State
Mexico	University of Guadalajara	Guadalajara	Jalisco

Sponsors (3)

Lead Sponsor	Collaborator
Centro Universitario de Tonalá	Diabetes sin Complicaciones S.A de C.V, Mexico, University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain perception	Evaluation of neuropathic pain evaluated with VAS	Change from Baseline Pain perception at 90 days
Secondary	Tumoral Necrosis Factor Alpha	Serum levels of TNF-alpha	Change from Baseline serum levels of TNF-alpha at 90 days
Secondary	Interleukin-6	Serum levels of IL-6	Change from Baseline serum levels of IL-6 at 90 days
Secondary	C Reactive Protein ultra-sensible	Serum levels of CRP-us	Change from Baseline serum levels of CRP-us at 90 days