I70.2
Conditions
Interventions
Group 1: Intervention Group: Verum Device
In this prospective, double blinded trial the stimulation of afferent nerve fibers of the outer ear using an electroacupuncture device was carried out.
In
Sponsors
Angiologie, Meduni Graz
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria were a written informed consent and a lifestyle-limiting PAOD due to calf-pain in Fontaine-stage IIb existing for at least 6 months. Furthermore, at least one hemodynamically relevant vascular obstruction or vascular occlusion in the arterial femoropopliteal area had to be verified with radiological imaging (MR-Angiography, CT-Angiography, Colour coded Duplex Sonography or Digital Subtraction Angiography).
Exclusion criteria
Exclusion criteria: Relevant exclusion criteria were a known symptomatic diabetic polyneuropathy, claudicatio spinalis, atrial fibrillation, therapy with prostanoids within the last 6 months, structured exercise training within the last 6 months, myocardial infarction within the last 6 months, stroke / transitory ischemic attack within the last 6 months, pregnancy, any kind of paralyses of the limbs, other implanted devices (pacemaker, implanted cardioverter defibrillator, cardiac resynchronization therapy, implanted analgesics pump) as well as a known malignant neoplasia. Moreover, patients were not included in the trial if the walking distance was anamnestically limited by other causes than intermittent claudication (e.g. dyspnoea or chest pain).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Significantly more frequent doubling of the maximum (absolute) walking distance (+100%) after 8 cycles (8 weeks) in the verum group compared to controls. | — |
Secondary
| Measure | Time frame |
|---|---|
| Statistically significant improvement of the total score of WIQ as well as statistically significant improvement of Health Related Quality of Life (HRQoL) based on SF-36 after 8 cycles (8 weeks) of therapy. | — |
Countries
Austria
Contacts
Public ContactGerald Hackl
Angiologie, Meduni Graz
Outcome results
None listed