Evidence mapPaperPMID 28797281Full record

Trial reportTrials2017

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.

Florent Besnier, Jean-Michel Sénard, Vincent Grémeaux, Mélanie Riédel, Damien Garrigues, Thibaut Guiraud, Marc Labrunée

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02678403 (Efficacy of Transcutaneous Electrical Nerve Stimulation in the Improvement of Walking Distance in Patients With Peripheral Artery Disease With Intermittent Claudication), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.7field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02678403 naterminatednot on this mapstarted 2018, after this paper: background citation

Efficacy of Transcutaneous Electrical Nerve Stimulation in the Improvement of Walking Distance in Patients With Peripheral Artery Disease With Intermittent Claudication

TypeinterventionalSponsorUniversity Hospital, ToulouseRan2018 to 2019Enrolled8ConditionsPeripheral Artery DiseaseArmsTranscutaneous electrical nerve stimulation (TENS), SHAM Transcutaneous electrical nerve stimulation (TENS)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 6 institutions in 2 countries.

Florent BesnierInstitute of Metabolic and Cardiovascular Diseases (I2MC) team 8, Université de Toulouse National Institute of Health and Medical Research (INSERM), Toulouse, France.
Jean-Michel SénardInstitute of Metabolic and Cardiovascular Diseases (I2MC) team 8, Université de Toulouse National Institute of Health and Medical Research (INSERM), Toulouse, France.
Vincent GrémeauxPôle Rééducation-Réadaptation and Plateforme d'Investigation Technologique INSERM CIC 1432, Dijon University Hospital, Dijon, France.
Mélanie RiédelDepartment of Cardiovascular Rehabilitation, Reunion University Hospital, Réunion Island, France.
Damien GarriguesClinic of Saint-Orens, Cardiovascular and Pulmonary Rehabilitation Centre, Saint-Orens-de-Gameville, France.
Thibaut GuiraudInstitute of Metabolic and Cardiovascular Diseases (I2MC) team 8, Université de Toulouse National Institute of Health and Medical Research (INSERM), Toulouse, France.
Marc LabrunéeInstitute of Metabolic and Cardiovascular Diseases (I2MC) team 8, Université de Toulouse National Institute of Health and Medical Research (INSERM), Toulouse, France. labrunee.m@chu-toulouse.fr.
Institut des Maladies Métaboliques et Cardiovasculaires · FRCentre de Physiopathologie de Toulouse-Purpan · FRCentre d’Investigation Clinique 1436Conseil Régional de La Réunion · REInserm · FRL'Oréal (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn patients with peripheral arterial disease (PAD), walking improvements are often limited by early pain onset due to vascular claudication. It would thus appear interesting to develop noninvasive therapeutic strategies, such as transcutaneous electrical nerve stimulation (TENS), to improve the participation of PAD patients in rehabilitation programmes, and thus improve their quality of life. Our team recently tested the efficacy of a single 45-min session of 10-Hz TENS prior to walking. TENS significantly delayed pain onset and increased the pain-free walking distance in patients with class-II PAD. We now seek to assess the efficacy of a chronic intervention that includes the daily use of TENS for 3 weeks (5 days a week) on walking distance in Leriche-Fontaine stage-II PAD patients. METHODS/

designThis is a prospective, double-blind, multicentre, randomised, placebo-controlled trial. One hundred subjects with unilateral PAD (Leriche-Fontaine stage II) will be randomised into two groups (1:1). For the experimental group (TENS group): the treatment will consist of stimulation of the affected leg (at a biphasic frequency of 10 Hz, with a pulse width of 200 μs, maximal intensity below the motor threshold) for 45 min per day, in the morning before the exercise rehabilitation programme, for 3 weeks, 5 days per week. For the control group (SHAM group): the placebo stimulation will be delivered according to the same modalities as for the TENS group but with a voltage level automatically falling to zero after 10 s of stimulation. First outcome: walking distance without pain. SECONDARY OUTCOMES: transcutaneous oxygen pressure (TcPO DISCUSSION: TENS-PAD is the first randomised controlled trial that uses transcutaneous electrical therapy as an adjuvant technique to improve vascular function in the treatment of PAD. If the results are confirmed, this technique could be incorporated into the routine care in cardiovascular rehabilitation centers and used in the long term by patients to improve their walking capacity.

trial registrationClinicalTrials.gov, ID: NCT02678403 . Registered on 9 February 2016. SPONSOR: Toulouse University Hospital.

Indexed as

Exercise ToleranceTranscutaneous Electric Nerve StimulationWalkingAdolescentAdultAgedAged, 80 and overClinical ProtocolsCombined Modality TherapyDouble-Blind MethodExercise TherapyFemaleFranceHumansIntermittent ClaudicationMaleEndothelial functionPeripheral arterial diseasePhysical activityTranscutaneous electrical nerve stimulation

Identifiers

PMID28797281
PMCPMC5553808
OpenAlexW2743364755

What Socratic holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.