Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis

NCT ID: NCT02434419

Last Updated: 2015-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-04-30

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.

Conditions

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Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PENS with training

Patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training during 12 weeks postoperatively

Group Type EXPERIMENTAL

PENS

Intervention Type 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

Intervention Type OTHER

Patients underwent specific training exercises to improve pectoral fitness.

Specific training

Patients undergoing specific training during 12 weeks postoperatively

Group Type ACTIVE_COMPARATOR

Specific training

Intervention Type OTHER

Patients underwent specific training exercises to improve pectoral fitness.

No intervention

No specific treatment was assigned to these patients postoperatively

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Specific training

Patients underwent specific training exercises to improve pectoral fitness.

Intervention Type OTHER

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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

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Jaime Ruiz-Tovar, MD, PhD

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaime Ruiz-Tovar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Elche

Other Identifiers

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HURJC2015-02

Identifier Type: -

Identifier Source: org_study_id

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