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Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02434419
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : May 5, 2015
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

Brief 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.


Condition or disease Intervention/treatment Phase
Satisfaction Device: PENS Other: Specific training Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis After Bariatric Surgery
Study Start Date : January 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: PENS with training
Patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training during 12 weeks postoperatively
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.

Active Comparator: Specific training
Patients undergoing specific training during 12 weeks postoperatively
Other: Specific training
Patients underwent specific training exercises to improve pectoral fitness.

No Intervention: No intervention
No specific treatment was assigned to these patients postoperatively



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434419


Sponsors and Collaborators
Hospital General Universitario Elche
Investigators
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Principal Investigator: Jaime Ruiz-Tovar, MD, PhD Hospital General Elche
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Responsible Party: Jaime Ruiz-Tovar, MD, PhD, MD, PhD, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT02434419    
Other Study ID Numbers: HURJC2015-02
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: April 2015