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

Toulouse University Hospital

Status: Terminated

Conditions: Peripheral Artery Disease

Treatments: Device: SHAM Transcutaneous electrical nerve stimulation (TENS); Device: Transcutaneous electrical nerve stimulation (TENS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02678403

RC31/14/7386

2015-A01534-45 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral Leriche stage II PAD, admitted to cardiovascular Rehabilitation Unit
• Men or women
• Able to take part in an out-patient rehabilitation programme
• Clinically stable
• Sedentary
• Provided informed consent to participate in the study

Exclusion criteria

• Ward of court
• Walking disorders related to orthopaedic or neuromuscular disease
• Participation in a structured physical reconditioning programme in the month before the study
• Renal insufficiency requiring dialysis
• Known and documented myopathy
• Progressive cancer
• Associated progressive disease causing a deterioration in general health
• Participation in another research protocol
• Skin disorder making it impossible to use TENS
• Absolute contra-indication to physical activity
• Presence of pacemaker / defibrillator
• Pregnant women in the 1st trimester / 12 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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8 participants in 2 patient groups

1 - TENS group

Experimental group

Description:

The treatment will consist of Transcutaneous electrical nerve stimulation (TENS): 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.

Treatment:

Device: Transcutaneous electrical nerve stimulation (TENS)

2 - SHAM group

Sham Comparator group

Description:

SHAM Transcutaneous electrical nerve stimulation (TENS) : 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.

Treatment:

Device: SHAM Transcutaneous electrical nerve stimulation (TENS)