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Effect of Transcutaneous Electrical Nerve Stimulation in Peripheral Artery Disease TENS-PAD Study / TENS-AOMI

NCT02678403 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-02-04

No results posted yet for this study

Summary

Purpose: The investigators team recently carried out a proof of concept study testing the efficacy of one single 45-minute session of 10 Hz TENS prior to walking, versus placebo. In this randomized study, the investigators found that TENS significantly delayed pain onset and increased the pain-free walking distance in patients with class II PAD. From these encouraging results, the investigators now seek to assess the efficacy of an intervention that includes the daily use of TENS for 3 weeks (5 days a week) on walking distance in PAD (Leriche-Fontaine stage II). Methods/Design: prospective multicentre study / randomized controlled trial / double blinding.

Conditions

Interventions

DEVICE

Transcutaneous electrical nerve stimulation (TENS)

Transcutaneous electrical nerve stimulation (TENS) is the use of electric current produced by a device to stimulate the nerves that only induces sensory stimulation (without muscle contraction) and is classically used in the treatment of pain.

DEVICE

SHAM Transcutaneous electrical nerve stimulation (TENS)

Transcutaneous electrical nerve stimulation (TENS) is the use of electric current produced by a device to stimulate the nerves that only induces sensory stimulation (without muscle contraction) and is classically used in the treatment of pain.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Marc LABRUNEE, MD · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-16
Primary Completion
2019-09-16
Completion
2019-09-16

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02678403 on ClinicalTrials.gov