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Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis

NCT02434419 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2015-05-05

No results posted yet for this study

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.

Conditions

  • Satisfaction

Interventions

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.

Sponsors & Collaborators

  • Hospital General Universitario Elche

    lead OTHER

Principal Investigators

  • Jaime Ruiz-Tovar, MD, PhD · Hospital General Elche

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-04-30
Completion
2015-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02434419 on ClinicalTrials.gov