HTEMS Treatment of Diabetic Polyneuropathy

West German Center of Diabetes and Health80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Diabetic Polyneuropathy

Interventions

HTEMSDEVICE

high-tone external muscle stimulation

PlaceboDEVICE

Placebo stimulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * symptomatic diabetic neuropathy * stable oral analgesic regimen Exclusion Criteria: * history of drug or alcohol abuse * cardiac pacemaker or defibrillator * pregnancy

Locations (1)

West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group

Düsseldorf, Germany

Outcomes

Primary Outcomes

Neuropathy symptom score

Neuropathic symptoms measured by the neuropathic symptom score (NSS). Range 1-10 with higher scores indicationg a worse outcome.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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