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Methodological Properties of Transcutaneous Electrical Nerve Stimulation (TENS) Equipment Used for Analgesia in Humans: a Systematic Review

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Abstract

Pain is considered a public health problem due to its high economic cost, high prevalence, and great impact on the quality of life of patients and their families. Transcutaneous electrical nerve stimulation (TENS) has been shown to be a safe, inexpensive option with satisfactory results in improving pain control. However, the success of this therapy presents as key factors the parameters used, among them the intensity and duration of treatment. However, little is known about the validation of such equipment. To perform a systematic review of the equipment available for the application of electrostimulation as a therapeutic resource for analgesia, which had their methodological properties tested. A systematic literature search was conducted for all relevant scientific articles in the SCIELO, Medline/PubMed, PEDRo, and EBSCO databases. A total of 318 articles were found. Sixty-six were duplicate studies, 252 were selected by title, 72 by abstract, 5 by text full reading, and finally only 2 were included, since the others did not meet the pre-established inclusion criteria. The evidence gathered in this study shows that the performance evaluation of commercially available electrostimulation equipment may be a responsibility of the national regulatory agency. Our findings reinforce the importance of greater availability of information about the regulatory processes of these devices and the verification of the parameters of the regulated devices, so that the achievement of therapeutic goals is not compromised.

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Data Availability

The detailed strategy and the operational definitions of qualitative analysis are available in Appendix 1 and 2.

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Acknowledgements

The authors would like to thank the library of FUMEC University, for its assistance in the systematic search of scientific articles.

Funding

This study was financed in part by Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES) – Finance Code 001.

Author information

Authors and Affiliations

  1. Associação Mineira de Reabilitação, Orthotics for Humans Laboratory (OhLab), Child Rehabilitation Center, Rua Professor Otávio Coelho de Magalhães, 111, Mangabeiras -, Belo Horizonte, MG, 30210-300, Brazil

    Igor Batista Guimarães, Mariana Ribeiro Volpini Lana, Mariana Rodrigues Carvalho de Aquino & Davi Neiva Alves

  2. Graduate Program in Mechanical Engineering, Bioengineering Laboratory Labbio, Universidade Federal de Minas Gerais, Av. Presidente Antônio Carlos, 6627, Pampulha -, Belo Horizonte, MG, 31270-901, Brazil

    Igor Batista Guimarães & Claysson Bruno Santos Vimieiro

  3. Faculty of Engineering and Architecture, Biomedical Engineering Department, Universidade FUMEC, Rua Cobre Street, 200, Cruzeiro -, Belo Horizonte, MG, 30310-190, Brazil

    Mariana Ribeiro Volpini Lana & Jessé Mendonça Cavalheiro

  4. Graduate Program in Mechanical Engineering, Pontifícia Universidade Católica de Minas Gerais, Av. Dom José Gaspar, 500, Coração Eucarístico -, Belo Horizonte, MG, 30535-901, Brazil

    Claysson Bruno Santos Vimieiro

Authors
  1. Igor Batista Guimarães
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  2. Mariana Ribeiro Volpini Lana
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  3. Mariana Rodrigues Carvalho de Aquino
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  4. Jessé Mendonça Cavalheiro
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  5. Davi Neiva Alves
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  6. Claysson Bruno Santos Vimieiro
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Contributions

A statement specifying the contributions of every author should be added.

Igor Batista Guimarães: conceptualization, methodology, writing – review and editing, visualization, supervision. Mariana Ribeiro Volpini Lana: conceptualization, methodology, resources, formal analysis, investigation, writing – original draft, visualization, supervision. Mariana R C Aquino: methodology, software, formal analysis, investigation, writing – original draft, visualization. Jessé Mendonça Cavalheiro: conceptualization, methodology, visualization. Davi Neiva Alves: methodology, writing – review and editing, visualization. Claysson Bruno Santos Vimieiro: writing – review and editing, visualization, supervision.

Corresponding author

Correspondence to Mariana Ribeiro Volpini Lana.

Ethics declarations

Ethics Approval

This study did not involve research with human beings, being a systematic review of scientific papers. Therefore, its submission was not necessary to the appreciation of an Ethics in Research Committee (CEP).

Conflict of Interest

The authors declare no competing interests.

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This article is part of the Topical Collection on Medicine

Appendices

Appendix 1. Detailed strategy for each source

English

EBSCO

http://web.a.ebscohost.com/ehost/results?vid=2&sid=3f22a0a9-3520-4438-989c-91263f10b037%40sdc-vsessmgr03&bquery=Transcutaneous+Electric+Nerve+Stimulation&bdata=JmRiPWFwaCZsYW5nPXB0LWJyJnR5cGU9MCZzZWFyY2hNb2RlPVN0YW5kYXJkJnNpdGU9ZWhvc3QtbGl2ZQ%3d%3d

Bireme

http://bases.bireme.br/cgi-bin/wxislind.exe/iah/online/

  1. 1.2.

    SCIELO

https://search.scielo.org/?q=Transcutaneous+electric+nerve+stimulation&lang=pt&count=15&from=0&output=site&sort=&format=summary&fb=&page=1&q=Transcutaneous+Electric+Nerve+Stimulation&lang=pt&page=1

Medline/PubMed

https://www.ncbi.nlm.nih.gov/pubmed/?term=Transcutaneous+Electric+Nerve+Stimulation

PEDro

https://search.pedro.org.au/search-results?calc_text=Transcutaneous+Electric+Nerve+Stimulation&-find=Search&page=

Spanish

2.1. EBSCO

http://web.a.ebscohost.com/ehost/results?vid=3&sid=3f22a0a9-3520-4438-989c-91263f10b037%40sdc-vsessmgr03&bquery=Estimulaci%c3%b3n+El%c3%a9ctrica+Transcut%c3%a1nea+del+Nervio&bdata=JmRiPWFwaCZsYW5nPXB0LWJyJnR5cGU9MCZzZWFyY2hNb2RlPVN0YW5kYXJkJnNpdGU9ZWhvc3QtbGl2ZQ%3d%3d

Bireme

http://bases.bireme.br/cgi-bin/wxislind.exe/iah/online/

SCIELO

https://search.scielo.org/?q=&lang=pt&count=15&from=0&output=site&sort=&format=summary&fb=&page=1&q=Estimulaci%C3%B3n+El%C3%A9ctrica+Transcut%C3%A1nea+del+Nervio&lang=pt&page=1

Medline/PubMed

https://www.ncbi.nlm.nih.gov/pubmed/?term=Estimulaci%C3%B3n+El%C3%A9ctrica+Transcut%C3%A1nea+del+Nervio

Portuguese

EBSCO

http://web.a.ebscohost.com/ehost/results?vid=4&sid=3f22a0a9-3520-4438-98991263f10b037%40sdc-vsessmgr03&bquery=Estimula%c3%a7%c3%a3o+El%c3%a9trica+Nervosa+Transcut%c3%a2nea&bdata=JmRiPWFwaCZsYW5nPXB0LWJyJnR5cGU9MCZzZWFyY2hNb2RlPVN0YW5kYXJkJnNpdGU9ZWhvc3QtbGl2ZQ%3d%3d

Bireme

http://bases.bireme.br/cgi-bin/wxislind.exe/iah/online/

SCIELO

https://search.scielo.org/?q=&lang=pt&count=15&from=0&output=site&sort=&format=summary&fb=&page=1&q=Estimula%C3%A7%C3%A3o+El%C3%A9trica+Nervosa+Transcut%C3%A2nea&lang=pt&page=

Medline/PubMed

https://www.ncbi.nlm.nih.gov/pubmed/?term=Estimula%C3%A7%C3%A3o+El%C3%A9trica+Nervosa+Transcut%C3%A2nea

Appendix 2. Risk of bias criteria: operational definitions

Adequate sequence generation?

  1. 1.

    Low risk of bias: based on a random component judged to be both appropriate and sufficiently well described.

  2. 2.

    High risk of bias: based on any non-random component.

  3. 3.

    Unclear risk of bias: insufficient information regarding sequence generation process to permit judgment of low or high risk of bias.

Adequate allocation concealment?

  1. 1.

    Low risk of bias: method of concealment allocation employed prohibited foresight of participant assignment.

  2. 2.

    High risk of bias: method of concealment allocation employed permitted possible foresight of participant assignment.

  3. 3.

    Unclear risk of bias: method of concealment allocation not described or described in insufficient detail to permit judgment of low or high risk of bias.

Blinding of outcome assessment?

  1. 1.

    Low risk of bias: outcome assessor (including participants with respect to self-reported outcomes) blinded to participants’ allocated intervention, and unlikely that blinding broken; OR no or incomplete blinding but judged that a given outcome unlikely to be influenced by lack of blinding.

  2. 2.

    High risk of bias: outcome assessor (including participants with respect to self-report outcomes) unblinded to participants’ allocated intervention; OR outcome assessor blinded to allocated intervention but likely that blinding may have been broken (and a given outcome is likely to be influenced by lack of blinding).

  3. 3.

    Unclear risk of bias: insufficient information to permit judgment of low or high risk of bias.

Blinding of participants?

  1. 1.

    Low risk of bias: participants blinded to allocated intervention and unlikely that blinding broken; OR no or incomplete blinding but judged that a given outcome unlikely to be influenced by lack of blinding.

  2. 2.

    High risk of bias: participants not blinded to allocated intervention; OR participants blinded to allocated intervention but likely that blinding may have been broken (and a given outcome is likely to be influenced by lack of blinding).

  3. 3.

    Unclear risk of bias: insufficient information to permit judgment of low or high risk of bias.

Incomplete outcome data addressed?

  1. 1.

    Low risk of bias: no missing outcome data. Reasons for missing data unlikely to be related to the true outcome. Missing outcome data balanced across intervention groups with similar reasons for omissions. Dichotomous outcomes: proportion of missing outcomes compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate. Continuous outcomes: difference in means or standardized mean difference among missing outcomes not enough to have a clinically relevant impact on observed effect size. Missing data imputed using appropriate methods. Intention-to-treat analysis undertaken. Less than or equal to 10% dropout rate.

  2. 2.

    High risk of bias: reason for missing outcome data likely to be related to the true outcome. Dichotomous outcomes: proportion of missing outcomes compared with observed event risk enough to induce a clinically relevant bias in intervention effect estimate. Continuous outcomes: difference in means or standardized mean difference among missing outcomes enough to induce a clinically relevant bias on observed effect size. As-treated analysis undertaken with substantial departure of the intervention received from that assigned at randomization. Equal to or greater than 30% dropout rate.

  3. 3.

    Unclear risk of bias: insufficient reporting of attrition or exclusions to permit judgment of low or high risk of bias. Greater than 10% and less than 30% dropout rate.

Selective outcome reporting?

  1. 1.

    Low risk of bias: all primary outcomes of interest adequately reported with point estimates and measures of variance for all time points.

  2. 2.

    High risk of bias: incomplete reporting of prespecified outcomes. One or more primary outcomes are reported using measurements, analysis methods, or subsets of data that were not prespecified. One or more reported primary outcomes were not prespecified. One or more outcomes of interest reported incompletely and cannot be entered into a meta-analysis. Results for a key outcome expected to have been reported, excluded.

  3. 3.

    Unclear risk of bias: insufficient information to permit judgment of low or high risk of bias.

Free of other biases

  1. 1.

    Low risk of bias: appears free of other sources of bias.

  2. 2.

    High risk of bias: results may have been confounded by at least one important risk of bias (design-specific, fraudulent, other).

  3. 3.

    Unclear risk of bias: other sources of bias may be present but there is either insufficient information to assess whether an important risk of bias exists; OR insufficient rationale or evidence regarding whether an identified problem will introduce bias.

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Guimarães, I.B., Volpini Lana, M.R., de Aquino, M.R.C. et al. Methodological Properties of Transcutaneous Electrical Nerve Stimulation (TENS) Equipment Used for Analgesia in Humans: a Systematic Review. SN Compr. Clin. Med. 3, 1363–1372 (2021). https://doi.org/10.1007/s42399-021-00845-z

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