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HTEMS-RCT: HTEMS Treatment of Diabetic Polyneuropathy

Sponsor
West German Center of Diabetes and Health (Other)
Overall Status
Completed
CT.gov ID
NCT04593992
Collaborator
gbo Medizintechnik AG (Other)
80
Enrollment
1
Location
2
Arms
14.4
Actual Duration (Months)
5.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: HTEMS
  • Device: Placebo
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
High-tone External Muscle Stimulation for Treatment of Diabetic Polyneuropathy
Actual Study Start Date :
Oct 20, 2020
Actual Primary Completion Date :
Oct 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Neuropathy symptom score [12 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • symptomatic diabetic neuropathy

    • stable oral analgesic regimen

    Exclusion Criteria:

    • history of drug or alcohol abuse

    • cardiac pacemaker or defibrillator

    • pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group Düsseldorf Germany 40591

    Sponsors and Collaborators

    • West German Center of Diabetes and Health
    • gbo Medizintechnik AG

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stephan Martin, Principal investigator, West German Center of Diabetes and Health
    ClinicalTrials.gov Identifier:
    NCT04593992
    Other Study ID Numbers:
    • HP study
    First Posted:
    Oct 20, 2020
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Stephan Martin, Principal investigator, West German Center of Diabetes and Health
    diabetes
    neuropathy
    pain
    HTEMS
    Additional relevant MeSH terms:
    Polyneuropathies
    Diabetic Neuropathies

    Study Results

    No Results Posted as of Jul 20, 2022