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Completed

NCT Number: NCT04593992

HTEMS Treatment of Diabetic Polyneuropathy

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.

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Key information

Conditions

Diabetic Polyneuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Düsseldorf, 40591, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • symptomatic diabetic neuropathy
  • stable oral analgesic regimen

Exclusion criteria

  • history of drug or alcohol abuse
  • cardiac pacemaker or defibrillator
  • pregnancy

Treatment and study plan

HTEMS

Device

high-tone external muscle stimulation

Other names: HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany)

PLACEBO

Device

Placebo stimulation

Other names: Placebo treatment

Primary outcomes

  1. Neuropathy symptom score

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

West German Center of Diabetes and Health

Other

Collaborators

  • gbo Medizintechnik AG

Registry information

Official study title

High-tone External Muscle Stimulation for Treatment of Diabetic Polyneuropathy

Acronym: HTEMS-RCT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 20, 2020
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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