Effect of Transcutaneous Electrical Nerve Stimulation in Diabetic Neuropathy
Phase 3
Terminated
- Conditions
- Diabetic Neuropathy Peripheral
- Registration Number
- NCT04253860
- Lead Sponsor
- Centro Universitario de Tonalá
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain perception Change from Baseline Pain perception at 90 days Evaluation of neuropathic pain evaluated with VAS
- Secondary Outcome Measures
Name Time Method Tumoral Necrosis Factor Alpha Change from Baseline serum levels of TNF-alpha at 90 days Serum levels of TNF-alpha
C Reactive Protein ultra-sensible Change from Baseline serum levels of CRP-us at 90 days Serum levels of CRP-us
Interleukin-6 Change from Baseline serum levels of IL-6 at 90 days Serum levels of IL-6
Trial Locations
- Locations (1)
University of Guadalajara
🇲🇽Guadalajara, Jalisco, Mexico
University of Guadalajara🇲🇽Guadalajara, Jalisco, Mexico