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

NCT02678403 | Terminated DMC

• 2 other identifiers: RC31/14/73862015-A01534-45
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 4

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.

Conditions

Peripheral Artery Disease

Keywords

peripheral artery disease; transcutaneous electrical nerve stimulation; walking ability; endothelial function

Outcome Measures

Primary Outcomes (1)

• walking distance without pain (in meters)

  the evolution of the claudication distance between the start and the end of the study (1 session of TENS each day , 15 days in total) in the two intervention group (TENS vs SHAM). Measure of change between inclusion and end of study.

  Change between J0 and J25 (15 days)

Secondary Outcomes (1)

• maximal oxygen consumption (VO2peak in ml.min)

  Change between J0 and J25 (15 days)

Study Arms (2)

1 - TENS group

EXPERIMENTAL

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.

Device: Transcutaneous electrical nerve stimulation (TENS)

2 - SHAM group

SHAM COMPARATOR

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.

Device: SHAM Transcutaneous electrical nerve stimulation (TENS)

Interventions

Transcutaneous electrical nerve stimulation (TENS) 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.

1 - TENS group

SHAM Transcutaneous electrical nerve stimulation (TENS) 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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Ministry of Health, France: collaborator

Study Sites (4)

University Hospital of Dijon

Dijon, 21079, France

Location

University Hospital of Nîmes

Nîmes, France

Location

Clinique de Saint-Orens

Saint-Orens-de-Gameville, 31650, France

Location

Toulouse University Hospital (CHU de Toulouse)

Toulouse, 31059, France

Location

Related Publications (1)

• 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.

  PMID: 28797281 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Marc LABRUNEE, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: February 9, 2016
• Study Start: August 16, 2018
• Primary Completion: September 16, 2019
• Study Completion: September 16, 2019
• Last Updated: February 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)