Diabetic Neuropathy Peripheral
Conditions
Keywords
Diabetic neuropathy peripheral, diabetic complications, TENS, Neuropathic treatments
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
Interventions
Sessions of 30 minutes of TENS will be applied three times a week during 90 days
Sponsors
University of Guadalajara
Diabetes sin Complicaciones S.A de C.V, Mexico
Centro Universitario de Tonalá
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Randomized, double-blind, clinical trial
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain perception | Change from Baseline Pain perception at 90 days | Evaluation of neuropathic pain evaluated with VAS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumoral Necrosis Factor Alpha | Change from Baseline serum levels of TNF-alpha at 90 days | Serum levels of TNF-alpha |
| Interleukin-6 | Change from Baseline serum levels of IL-6 at 90 days | Serum levels of IL-6 |
| C Reactive Protein ultra-sensible | Change from Baseline serum levels of CRP-us at 90 days | Serum levels of CRP-us |
Countries
Mexico
Outcome results
None listed