Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis
NCT ID: NCT02434419
Last Updated: 2015-05-05
Study Results
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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COMPLETED
PHASE3
45 participants
INTERVENTIONAL
2014-01-31
2015-04-30
Brief Summary
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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.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
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
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.
Specific training
Patients underwent specific training exercises to improve pectoral fitness.
Specific training
Patients undergoing specific training during 12 weeks postoperatively
Specific training
Patients underwent specific training exercises to improve pectoral fitness.
No intervention
No specific treatment was assigned to these patients postoperatively
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.
Specific training
Patients underwent specific training exercises to improve pectoral fitness.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
FEMALE
No
Sponsors
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Hospital General Universitario Elche
OTHER
Responsible Party
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Jaime Ruiz-Tovar, MD, PhD
MD, PhD
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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