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Pulsed Electromagnetic Fields (PEMF) and Post-Axillary Surgery Morbidity

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ClinicalTrials.gov Identifier: NCT01255631
Recruitment Status : Terminated (Poor enrollment)
First Posted : December 7, 2010
Results First Posted : October 16, 2015
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
Christine Hsu Rohde, MD, Columbia University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Shoulder Symptoms After Lymph Node Dissection
Interventions: Device: PEMF Device
Device: Sham PEMF Device

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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 PEMF device, delivers no PMF
PEMF Device PEMF Device: The PEMF device we will use in this study is FDA approved for "adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue" (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks.

Participant Flow:   Overall Study
    Sham PEMF Device   PEMF Device
STARTED   13   9 
COMPLETED   4 [1]   3 [1] 
NOT COMPLETED   9   6 
poor enrollment, no data analyzed                9                6 
[1] study terminated due to poor enrollment



  Baseline Characteristics

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.
Baseline analysis population was determined by the patients who completed the study (7 total patients: 4 Sham and 3 active PEMF)

Reporting Groups
  Description
Sham PEMF Device Sham PEMF Device: Inactive PEMF device, delivers no PMF
PEMF Device PEMF Device: The PEMF device we will use in this study is FDA approved for "adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue" (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks.
Total Total of all reporting groups

Baseline Measures
   Sham PEMF Device   PEMF Device   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   3   7 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   4   3   7 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   4   3   7 
Male   0   0   0 


  Outcome Measures

1.  Primary:   Pain Level on Visual Analog Scale   [ Time Frame: 2 weeks ]

2.  Secondary:   Jackson Pratt (JP) Drain Output   [ Time Frame: Post-Operative Day 1 & 2 (2 Days) ]

3.  Secondary:   Patient Self-Assessment of Shoulder and Arm Symptoms Before and After PEMF   [ Time Frame: Pre- and Post-Operative Period ]

4.  Secondary:   Clinical Assessment of Shoulder and Arm Symptoms Before and After PEMF   [ Time Frame: Pre- and Post-Operative Period ]

5.  Secondary:   Lymphedema   [ Time Frame: Pre- and Post-Operative Period ]

6.  Secondary:   Narcotic Pain Medications   [ Time Frame: Post-Operative Period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
Early termination leading to small numbers of subjects analyzed


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Christine Rohde
Organization: CUMC Plastic Surgery
phone: 212-342-3707
e-mail: chr2111@cumc.columbia.edu


Publications:

Responsible Party: Christine Hsu Rohde, MD, Columbia University
ClinicalTrials.gov Identifier: NCT01255631     History of Changes
Other Study ID Numbers: AAAE3803
First Submitted: December 1, 2010
First Posted: December 7, 2010
Results First Submitted: February 5, 2015
Results First Posted: October 16, 2015
Last Update Posted: October 16, 2015