Use of Pulsed Electromagnetic Fields (PEMF) After Breast Reconstruction Surgery

This study has been completed.
Sponsor:
Collaborator:
Ivivi Health Sciences, LLC
Information provided by (Responsible Party):
Christine Hsu Rohde, MD, Columbia University
ClinicalTrials.gov Identifier:
NCT01262599
First received: December 1, 2010
Last updated: August 4, 2015
Last verified: August 2015
Results First Received: May 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Breast and Abdomen Morbidities After TRAM Flap Surgery
Interventions: Device: Sham PEMF Device
Device: Ivivi Torino II PEMF Device

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited from medical offices of two participating plastic surgeons.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sham PEMF Device Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
PEMF Device Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for "adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue" (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours.

Participant Flow:   Overall Study
    Sham PEMF Device     PEMF Device  
STARTED     16     16  
COMPLETED     16     16  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sham PEMF Device Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
PEMF Device Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for "adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue" (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours.
Total Total of all reporting groups

Baseline Measures
    Sham PEMF Device     PEMF Device     Total  
Number of Participants  
[units: participants]
  16     16     32  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     15     15     30  
>=65 years     1     1     2  
Age  
[units: years]
Mean (Standard Deviation)
  53.5  (9.1)     51.1  (9.7)     52.3  (9.3)  
Gender  
[units: participants]
     
Female     16     16     32  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     16     16     32  
Body Mass Index (BMI)  
[units: kg/m2]
Mean (Standard Deviation)
  25.1  (3.1)     24.5  (3.4)     24.8  (3.2)  



  Outcome Measures

1.  Primary:   Change in Pain Level Between 1 Hours Post-op and 12 Hours Post-op   [ Time Frame: 12 hours ]

2.  Secondary:   Amount of Narcotic Pain Medications   [ Time Frame: 4 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Levels of Cytokines   [ Time Frame: 4 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Christine Rohde
Organization: Columbia University Medical Center
phone: (212) 342-3707
e-mail: chr2111@columbia.edu


Publications:
Publications automatically indexed to this study:

Responsible Party: Christine Hsu Rohde, MD, Columbia University
ClinicalTrials.gov Identifier: NCT01262599     History of Changes
Other Study ID Numbers: AAAE8848
Study First Received: December 1, 2010
Results First Received: May 12, 2015
Last Updated: August 4, 2015
Health Authority: United States: Institutional Review Board