HTEMS Treatment of Diabetic Polyneuropathy (HTEMS-RCT)

West German Center of Diabetes and Health

Status: Completed

Conditions: Diabetic Polyneuropathy

Treatments: Device: Placebo; Device: HTEMS

Study type: Interventional

Funder types: Other

Identifiers

NCT04593992

HP study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• symptomatic diabetic neuropathy
• stable oral analgesic regimen

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

HTEMS

Experimental group

Description:

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

Treatment:

Device: HTEMS

Placebo

Placebo Comparator group

Description:

Placebo stimulation 5 times within a week for 12 weeks

Treatment:

Device: Placebo