A Phase 3 interventional study of Transcutaneous electrical neurostimulation in Diabetic Neuropathy Peripheral, sponsored by Centro Universitario de Tonalá. Terminated at 1 site in Mexico. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-04.
Sponsored by Centro Universitario de Tonalá · Phase 3, Interventional, and Treatment
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
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →Centro Universitario de Tonalá is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Transcutaneous electrical neurostimulation will be applied for 30 minutes three times a week during 90 days
Device: 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
Device: Transcutaneous electrical neurostimulation
Sessions of 30 minutes of TENS will be applied three times a week during 90 days
Pain perception
Evaluation of neuropathic pain evaluated with VAS
Time frame: Change from Baseline Pain perception at 90 days
Tumoral Necrosis Factor Alpha
Serum levels of TNF-alpha
Time frame: Change from Baseline serum levels of TNF-alpha at 90 days
Interleukin-6
Serum levels of IL-6
Time frame: Change from Baseline serum levels of IL-6 at 90 days
C Reactive Protein ultra-sensible
Serum levels of CRP-us
Time frame: Change from Baseline serum levels of CRP-us at 90 days
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Peripheral Nervous System Diseases→
Centro Universitario de Tonalá