Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis
1 other identifier
interventional
45
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2014
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 30, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedMay 5, 2015
April 1, 2015
1.2 years
April 30, 2015
May 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
PENS with training
EXPERIMENTALPatients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training during 12 weeks postoperatively
Specific training
ACTIVE COMPARATORPatients undergoing specific training during 12 weeks postoperatively
No intervention
NO INTERVENTIONNo specific treatment was assigned to these patients postoperatively
Interventions
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.
Patients underwent specific training exercises to improve pectoral fitness.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- all kind of previous breast surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaime Ruiz-Tovar, MD, PhD
Hospital General Elche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 30, 2015
First Posted
May 5, 2015
Study Start
January 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
May 5, 2015
Record last verified: 2015-04