NCT02434419

Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Hospital General Universitario Elche · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Satisfaction

Interventions

Type	Name	Description
DEVICE	PENS	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.
OTHER	Specific training	Patients underwent specific training exercises to improve pectoral fitness.

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2015-05-05
• Last updated: 2015-05-05