Clinical trial NCT02678403: Effect of Transcutaneous Electrical Nerve Stimulation in Peripheral Artery Disease TENS-PAD Study / TENS-AOMI
Official title: Efficacy of Transcutaneous Electrical Nerve Stimulation in the Improvement of Walking Distance in Patients With Peripheral Artery Disease With Intermittent Claudication
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: peripheral artery disease
transcutaneous electrical nerve stimulation
walking ability
endothelial function
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2016-02-09
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: walking distance without pain (in meters)
timeFrame: Change between J0 and J25 (15 days)
Secondary outcomes:
measure: maximal oxygen consumption (VO2peak in ml.min)
timeFrame: Change between J0 and J25 (15 days)
Other outcomes:
Locations:
city: Dijon
country: France
facility: University Hospital of Dijon
city: Nîmes
country: France
facility: University Hospital of Nîmes
city: Saint-Orens de Gameville
country: France
facility: Clinique de Saint-Orens
city: Toulouse
country: France
facility: Toulouse University Hospital (CHU de Toulouse)
Study officials:
affiliation: University Hospital, Toulouse
name: Marc LABRUNEE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Besnier F, Senard JM, Gremeaux V, Riedel M, Garrigues D, Guiraud T, Labrunee M. The efficacy of transcutaneous electrical nerve stimulation on the improvement of walking distance in patients with peripheral arterial disease with intermittent claudication: study protocol for a randomised controlled trial: the TENS-PAD study. Trials. 2017 Aug 10;18(1):373. doi: 10.1186/s13063-017-1997-1.