Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-28 @ 3:21 AM
Study NCT ID:
NCT02678403
Status:
TERMINATED
Last Update Posted:
2022-02-04
First Post:
2016-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Transcutaneous Electrical Nerve Stimulation in Peripheral Artery Disease TENS-PAD Study / TENS-AOMI
Sponsor:
University Hospital, Toulouse
Organization:
Study Overview
Official Title:
Efficacy of Transcutaneous Electrical Nerve Stimulation in the Improvement of Walking Distance in Patients With Peripheral Artery Disease With Intermittent Claudication
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
principal investigator left Toulouse hospital
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TENS-PAD
Brief 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.
Detailed Description:
Interventions (2 groups): Experimental group (TENS group): the treatment will consist of stimulation of the leg (frequency of 10 Hz, Biphasic, with a pulse width of 200 µs, maximal intensity below motor threshold), 45 minutes per day, in the morning before the exercise rehabilitation programme, for 3 weeks, 5 days per week. Control group (group SHAM): the stimulation placebo will be delivered according to the same modalities as for the TENS group but with a voltage level that vanishes automatically after 10 seconds of stimulation.
15 days of interventions (TENS or SHAM) between J0 and J23, End of study for patient at J24-J25, two days for the last analyses who are the same of inclusion's visit J0.
Primary outcome: walking distance (metres) measured on a treadmill with a standardized protocol. Secondary outcomes: transcutaneous oxygen pressure (TcPO2) measured during a Strandness exercise test, peak oxygen uptake (VO2 peak) (ml.min.kg-1), endothelial function (EndoPAT®), ankle-brachial pressure index, body mass index, lipid profile (LDL-C, HDL-C, Triglycerides), fasting glycaemia, HbA1c, WELCH questionnaire.
15 days of interventions (TENS or SHAM) between J0 and J23, End of study for patient at J24-J25, two days for the last analyses who are the same of inclusion's visit J0.
Primary outcome: walking distance (metres) measured on a treadmill with a standardized protocol. Secondary outcomes: transcutaneous oxygen pressure (TcPO2) measured during a Strandness exercise test, peak oxygen uptake (VO2 peak) (ml.min.kg-1), endothelial function (EndoPAT®), ankle-brachial pressure index, body mass index, lipid profile (LDL-C, HDL-C, Triglycerides), fasting glycaemia, HbA1c, WELCH questionnaire.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2015-A01534-45 | OTHER | ID-RCB | View |