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HTEMS Treatment of Diabetic Polyneuropathy (HTEMS-RCT)

Primary Purpose

Diabetic Polyneuropathy

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
HTEMS
Placebo
Sponsored by
West German Center of Diabetes and Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Polyneuropathy focused on measuring diabetes, neuropathy, pain, HTEMS

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • symptomatic diabetic neuropathy
  • stable oral analgesic regimen

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HTEMS

Placebo

Arm Description

High-tone external muscle stimulation 5 times within a week for 12 weeks

Placebo stimulation 5 times within a week for 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 14, 2020
Last Updated
July 19, 2022
Sponsor
West German Center of Diabetes and Health
Collaborators
gbo Medizintechnik AG
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1. Study Identification

Unique Protocol Identification Number
NCT04593992
Brief Title
HTEMS Treatment of Diabetic Polyneuropathy
Acronym
HTEMS-RCT
Official Title
High-tone External Muscle Stimulation for Treatment of Diabetic Polyneuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West German Center of Diabetes and Health
Collaborators
gbo Medizintechnik AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Polyneuropathy
Keywords
diabetes, neuropathy, pain, HTEMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HTEMS
Arm Type
Experimental
Arm Description
High-tone external muscle stimulation 5 times within a week for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo stimulation 5 times within a week for 12 weeks
Intervention Type
Device
Intervention Name(s)
HTEMS
Other Intervention Name(s)
HITOP 191 (gbo Medizintechnik AG, Rimbach, Germany)
Intervention Description
high-tone external muscle stimulation
Intervention Type
Device
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo treatment
Intervention Description
Placebo stimulation
Primary Outcome Measure Information:
Title
Neuropathy symptom score
Description
Neuropathic symptoms measured by the neuropathic symptom score (NSS). Range 1-10 with higher scores indicationg a worse outcome.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: symptomatic diabetic neuropathy stable oral analgesic regimen Exclusion Criteria: history of drug or alcohol abuse cardiac pacemaker or defibrillator pregnancy
Facility Information:
Facility Name
West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group
City
Düsseldorf
ZIP/Postal Code
40591
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

HTEMS Treatment of Diabetic Polyneuropathy

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