Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Satisfaction

Intervention / Treatment
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* Device: PENS
* Other: Specific training


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PENS with training<br>Patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training during 12 weeks postoperatively | Device: PENS<br>* 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.<br>Other: Specific training<br>* Patients underwent specific training exercises to improve pectoral fitness.<br>|
| Active Comparator: Specific training<br>Patients undergoing specific training during 12 weeks postoperatively | Other: Specific training<br>* Patients underwent specific training exercises to improve pectoral fitness.<br>|
| No Intervention: No intervention<br>No specific treatment was assigned to these patients postoperatively | |

What is the study measuring?
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Primary Outcome Measures

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