HTEMS Treatment of Diabetic Polyneuropathy
- Conditions
- Diabetic Polyneuropathy
- Interventions
- Device: HTEMSDevice: Placebo
- Registration Number
- NCT04593992
- Lead Sponsor
- West German Center of Diabetes and Health
- Brief Summary
So far, there are no sufficient pharmacologic therapies for the treatment of diabetic neuropathy. Therefore, we evaluated application of high-tone external muscle stimulation (HTEMS) compared to placebo treatment in patients with diabetic neuropathy.
- Detailed Description
Patients (n=80) with symptomatic diabetic neuropathy will be included into this randomized controlled trial. Each intervention will be administered for a period of at least 30 min on at leat 5 days in a week. Health impairments will be assessed using the neuropathy symptom score (NSS) before, during and after intervention.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- symptomatic diabetic neuropathy
- stable oral analgesic regimen
- history of drug or alcohol abuse
- cardiac pacemaker or defibrillator
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HTEMS HTEMS High-tone external muscle stimulation 5 times within a week for 12 weeks Placebo Placebo Placebo stimulation 5 times within a week for 12 weeks
- Primary Outcome Measures
Name Time Method Neuropathy symptom score 12 weeks Neuropathic symptoms measured by the neuropathic symptom score (NSS). Range 1-10 with higher scores indicationg a worse outcome.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group
🇩🇪Düsseldorf, Germany