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

NCT ID: NCT02678403

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-16
• Study Completion Date: 2019-09-16

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.

Conditions

Peripheral Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1 - TENS group

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.

Group Type: EXPERIMENTAL

Transcutaneous electrical nerve stimulation (TENS)

Intervention Type: DEVICE

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.

2 - SHAM group

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.

Group Type: SHAM_COMPARATOR

SHAM Transcutaneous electrical nerve stimulation (TENS)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc LABRUNEE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital of Dijon

Dijon, , France

University Hospital of Nîmes

Nîmes, , France

Clinique de Saint-Orens

Saint-Orens-de-Gameville, , France

Toulouse University Hospital (CHU de Toulouse)

Toulouse, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 28797281 (View on PubMed)

Other Identifiers

2015-A01534-45

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/14/7386

Identifier Type: -

Identifier Source: org_study_id