NCT06202794

TENS for the Treatment of Pain and Respiratory Function Following Mastopexy With Augmentation

Status unknown NA Last updated 16 January 2024

What this trial tests

NA trial testing Experimental: Experimental group in Postoperative Pain in 84 participants. Status unknown.

Timeline

1 February 2024

Primary endpoint
1 May 2024

1 July 2024

Quick facts

Lead sponsor	Finis Terrae University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	84
Start date	1 February 2024
Primary completion	1 May 2024
Estimated completion	1 July 2024
Sites	1 location across Chile

Drugs / interventions tested

• Experimental: Experimental group
• Sham Comparator: Control group

Conditions studied

• Postoperative Pain — all drugs for Postoperative Pain →
• Respiratory Complication — all drugs for Respiratory Complication →

Sponsor

Finis Terrae University

Who can join

Adults 18 to 55, female only, with Postoperative Pain or Respiratory Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 of TENS on pain intensity in patients undergoing mastopexy with implants, given the existing evidence on the success of TENS 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 one hour after surgery and will remain for one hour. Four assessments will be performed: before treatment (T0), immediately after treatment (T1), one hour (T2) and four hours 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 of TENS 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 of TENS in terms of pain intensity at rest as well as during movements and respiratory function tests.

Keywords TENS, Mastopexy, Plastic Surgery, Physical therapy modalities, Clinical trial protocol

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Pacheco EF, Lyons TV, Liebano RE. · · 2025 · PMID 41331821 · DOI 10.1186/s13063-025-09231-9