Effects of transcutaneous electrical nerve stimulation for the treatment of pain and respiratory function following mastopexy with augmentation - Study protocol - randomized controlled trial

Sep 30, 2026

Uploaded by Mary Man

Pain after breast plastic surgery reduces patients’ quality of life, and physical therapy options such as transcutaneous electrical nerve stimulation (TENS) may help, yet no studies directly support TENS after mastopexy with augmentation. A two-arm, randomized sham-controlled trial with blinded assessors evaluates whether TENS added after surgery improves pain intensity at rest and during movement, and affects respiratory function outcomes. Primary and secondary measures include standardized pain assessments and inspiratory/expiratory pressures, plus vital capacity.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages12

Reading Time30 min

AccessFree to download

Abstract

Methods

Trial design and setting

Participants and interventions

Outcome measures

Discussion

Trial registration

Introduction

Background and rationale

Pain mechanisms and clinical relevance

Pacheco et al. Trials (2026) 27:7 [https://doi.org/10.1186/s13063-025-09231-9](https://doi.org/10.1186/s13063-025-09231-9) Trials STUDY PROTOCOL Open Access Effects of transcutaneous electrical nerve stimulation for the treatment of pain and respiratory function following mastopexy with augmentation: study protocol for a randomized controlled trial Esteban Fortuny Pacheco1,2* , Tomas Valverde Lyons3,4 and Richard Eloin Liebano2,5 Abstract Background Pain after breast plastic surgery affects quality of life. Physical therapy offers effective interventions for this condition, such as transcutaneous electrical nerve stimulation (TENS) . Although this resource has been used for more than 20 years, no studies have been published that support its use following this type of surgery. Therefore, the aim of the proposed study is to evaluate the effect ofTENS on pain intensity in patients undergoing mastopexy with implants, given the existing evidence on the success ofTENS for other conditions. Methods A two-arm, randomized, sham-controlled trial will be conducted with blinded assessors. The study will be carried out at the Exercise Physiology and Metabolism Lab of Finis Terrae University. Eligible participants will be women undergoing mastopexy with implants invited by a board-certified plastic surgeon. The participants will be randomly assigned to one of two study groups: Group 1 (surgery + TENS) and Group 2 (surgery + sham TENS) . TENS will be administered only 1 h after surgery and will remain for 1 h. Four assessments will be performed: before treatment (T0), immediately after treatment (T1), 1 h (T2), and 4 h after TENS (T3) . The primary outcome will be pain intensity at rest, pain intensity during movement (standardized movements of both arms: anterior flexion, abduction, and external rotation), and during respiratory function tests. Secondary outcome measures will be maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), and vital capacity (VC) . Discussion In this study, the effects ofTENS on patients with pain following mastopexy with implants will be compared to the effects of a sham TENS intervention. This RCT will offer novel evidence on the potential benefits ofTENSin terms of pain intensity at rest as well as during movements and respiratory function tests. Trial registration ClinicalTrials. gov NCT06202794 . Registered on January 11, 2024. Keywords TENS, Mastopexy, Plastic surgery, Physical therapy modalities, Clinical trial protocol *Correspondence: Esteban Fortuny Pacheco [efortunyp@uft.edu](efortunyp@uft.edu) Full list of author information is available at the end of the article © The Author(s) 2025. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit [http://creativecommons.org/licenses/by-nc-nd/4.0/](http://creativecommons.org/licenses/by-nc-nd/4.0/.)[.](http://creativecommons.org/licenses/by-nc-nd/4.0/.) Pacheco et al. Trials (2026) 27:7 Introduction Background and rationale {6a} Pain following breast reconstruction or augmentation surgery is of considerabl

FAQs

What is the study’s main goal?

To evaluate the effect of transcutaneous electrical nerve stimulation (TENS) on pain intensity in patients undergoing mastopexy with implants, and to assess related respiratory function outcomes.

How is the trial designed and controlled?

It is a two-arm, randomized, sham-controlled trial with blinded assessors comparing surgery plus TENS versus surgery plus sham TENS.

When will TENS be administered and how are outcomes measured?

TENS is administered only 1 hour after surgery and continues for 1 hour. Assessments occur before treatment (T0), immediately after (T1), 1 hour after (T2), and 4 hours after (T3).

What respiratory outcomes are included?

Secondary respiratory outcomes include maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), and vital capacity (VC).

Sep 30, 2026

Uploaded by Mary Man