Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis

Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis After Bariatric Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02434419

Enrollment

Registered

2015-05-05

Start date

2014-01-31

Completion date

2015-04-30

Last updated

2015-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Satisfaction

Brief summary

A prospective randomized clinical trial of patients undergoing bariatric surgery. Patients were randomly assigned into 3 groups: those patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1), those patients doing the specific training alone (Group 2) and those patients without any specific treatment (Group 3). The assigned treatment began 15 days after surgery and was maintained during 12 weeks.

Detailed description

A prospective randomized clinical trial of patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (RYGB) during 2014 was performed. Patients were randomly assigned using a random-number table into 3 groups: those patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1), those patients doing the specific training alone (Group 2) and those patients without any specific treatment (Group 3). The assigned treatment began 15 days after surgery and was maintained during 12 weeks.

Interventions

DEVICEPENS

The participants underwent one 30-min session every week for 12 consecutive weeks. PENS was delivered by a needle electrode inserted in the medioclavicular line, 2 cm below the clavicle at a 90° angle towards the skin at a depth of approximately 1 cm. PENS was undertaken at frequency of 20 Hz at the highest amplify (0-20 mA) without causing pain. PENS was delivered simultaneously in both pectoral muscles.

OTHERSpecific training

Patients underwent specific training exercises to improve pectoral fitness.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

* patients with body mass index (BMI) \>40 Kg/m2 or BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity, undergoing a bariatric procedure.

Exclusion criteria

* all kind of previous breast surgery.

Design outcomes

Primary

Measure	Time frame	Description
Satisfaction degree. 7-points Likert scale was used for the quantification.	12 weeks of treatment	The patients were asked to quantify their satisfaction degree with the esthetic results of their breasts after the treatment.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026