Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis

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.

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Key information

Conditions

Satisfaction Behavior Personal Satisfaction

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PENS

Device

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.

Specific training

Other

Patients underwent specific training exercises to improve pectoral fitness.

Primary outcomes

Satisfaction degree. 7-points Likert scale was used for the quantification.

Time frame: 12 weeks of treatment

The patients were asked to quantify their satisfaction degree with the esthetic results of their breasts after the treatment.

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: May 5, 2015
Registry last updated: May 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed