HTEMS Treatment of Diabetic Polyneuropathy

High-tone External Muscle Stimulation for Treatment of Diabetic Polyneuropathy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04593992

Acronym

HTEMS-RCT

Enrollment

Registered

2020-10-20

Start date

2020-10-20

Completion date

2021-12-31

Last updated

2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Polyneuropathy

Keywords

diabetes, neuropathy, pain, HTEMS

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.

Interventions

DEVICEHTEMS

high-tone external muscle stimulation

DEVICEPlacebo

Placebo stimulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* symptomatic diabetic neuropathy * stable oral analgesic regimen

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Neuropathy symptom score	12 weeks	Neuropathic symptoms measured by the neuropathic symptom score (NSS). Range 1-10 with higher scores indicationg a worse outcome.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026