HTEMS Treatment of Diabetic Polyneuropathy (HTEMS-RCT)

July 19, 2022 updated by: Stephan Martin, West German Center of Diabetes and Health

High-tone External Muscle Stimulation for 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany, 40591
        • West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • symptomatic diabetic neuropathy
  • stable oral analgesic regimen

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HTEMS
High-tone external muscle stimulation 5 times within a week for 12 weeks
Device: HTEMS
high-tone external muscle stimulation
Other Names:
  • HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany)
Placebo Comparator: Placebo
Placebo stimulation 5 times within a week for 12 weeks
Device: Placebo
Placebo stimulation
Other Names:
  • Placebo treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West German Center of Diabetes and Health

Collaborators

gbo Medizintechnik AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2020

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

October 14, 2020

First Submitted That Met QC Criteria

October 14, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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