ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: 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
Enrollment 22

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sham PEMF Device PEMF Device
Hide Arm/Group Description Sham PEMF Device: Inactive PEMF device, delivers no PMF 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.
Period Title: Overall Study
Started 13 9
Completed 4 [1] 3 [1]
Not Completed 9 6
Reason Not Completed
poor enrollment, no data analyzed             9             6
[1]
study terminated due to poor enrollment
Arm/Group Title Sham PEMF Device PEMF Device Total
Hide Arm/Group Description Sham PEMF Device: Inactive PEMF device, delivers no PMF 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 of all reporting groups
Overall Number of Baseline Participants 4 3 7
Hide Baseline Analysis Population Description
Baseline analysis population was determined by the patients who completed the study (7 total patients: 4 Sham and 3 active PEMF)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
3
 100.0%
7
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
Female
4
 100.0%
3
 100.0%
7
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Pain Level on Visual Analog Scale
Hide Description Pain will be the primary outcome measured by patient level of pain as quantified by a visual analog scale with written descriptions, and amount of pain medication used hourly until the patient is discharged (up to a maximum of six hours post-op), then daily for a total of two weeks post-op. The VAS pain scale ranges from 0 (no pain) to 10 (worst possible pain).
Time Frame 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 7 patients completed the study by quantifying the level of their pain post-operatively on a visual analog scale from 0-10. The medication logs and two week post-op analogs could not be utilized for the analysis since all 7 patients did not complete these logs.
Arm/Group Title Sham PEMF Device PEMF Device
Hide Arm/Group Description:
Sham PEMF Device: Inactive PEMF device, delivers no PMF
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.
Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.878  (2.811) 5.239  (2.979)
2.Secondary Outcome
Title Jackson Pratt (JP) Drain Output
Hide Description Total volume (in units of millimeters - mL) of Jackson Pratt (JP) drain output on post-operative day 1 and day 2 were recorded for patients in the study.
Time Frame Post-Operative Day 1 & 2 (2 Days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
For the 7 patients who completed the study, the mean and standard deviations for the total JP drain output (in milliliters - mL) from post-operative days 1 & 2 (2 days total) were analyzed as a secondary outcome.
Arm/Group Title Sham PEMF Device PEMF Device
Hide Arm/Group Description:
Sham PEMF Device: Inactive PEMF device, delivers no PMF
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.
Overall Number of Participants Analyzed 4 3
Mean (Standard Deviation)
Unit of Measure: milliliters (mL)
136.5  (74.633) 85.333  (39.272)
3.Secondary Outcome
Title Patient Self-Assessment of Shoulder and Arm Symptoms Before and After PEMF
Hide Description No participants were assessed for this secondary outcome measure: patient self-assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients did not complete the necessary surveys assessing their shoulder and arm symptoms; therefore, no meaningful results could be derived since there were no surveys to compare before and after PEMF data points.
Time Frame Pre- and Post-Operative Period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were assessed for this secondary outcome measure: patient self-assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients did not complete the necessary surveys assessing their shoulder and arm symptoms.
Arm/Group Title Sham PEMF Device PEMF Device
Hide Arm/Group Description:
Sham PEMF Device: Inactive PEMF device, delivers no PMF
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Clinical Assessment of Shoulder and Arm Symptoms Before and After PEMF
Hide Description No participants were assessed for this secondary outcome measure: clinical assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. There was a lack of post-clinical assessment data as well as poor patient compliance with the 14 day mark follow up. Therefore, no meaningful results could be derived since there was no quantifiable means to compare before and after PEMF data points.
Time Frame Pre- and Post-Operative Period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were assessed for this secondary outcome measure: clinical assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables due to lack of post-clinical assessment data and poor patient compliance with the 14 day mark follow up.
Arm/Group Title Sham PEMF Device PEMF Device
Hide Arm/Group Description:
Sham PEMF Device: Inactive PEMF device, delivers no PMF
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Lymphedema
Hide Description No participants were assessed for this secondary outcome measure: lymphedema. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. No meaningful quantifiable data could be obtained on degree of lymphedema, and thus effect of PEMF intervention could not be analyzed.
Time Frame Pre- and Post-Operative Period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were assessed for this secondary outcome measure: lymphedema. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. No meaningful quantifiable data could be obtained on degree of lymphedema, and thus effect of PEMF intervention could not be analyzed.
Arm/Group Title Sham PEMF Device PEMF Device
Hide Arm/Group Description:
Sham PEMF Device: Inactive PEMF device, delivers no PMF
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Narcotic Pain Medications
Hide Description No participants were assessed for this secondary outcome measure: narcotic pain medications. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients were instructed to complete logs at home indicating narcotic pain medications, and patients did not submit necessary logs assessing need for pain medications and level of nausea and vomiting; therefore, no meaningful data could be analyzed.
Time Frame Post-Operative Period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were assessed for this secondary outcome measure: narcotic pain medications. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients were instructed to complete logs at home indicating narcotic pain medications, and patients did not submit necessary logs.
Arm/Group Title Sham PEMF Device PEMF Device
Hide Arm/Group Description:
Sham PEMF Device: Inactive PEMF device, delivers no PMF
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Time frame for adverse event reporting was the time during which the PEMF device was on the patient, maximum 2 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sham PEMF Device PEMF Device
Hide Arm/Group Description Sham PEMF Device: Inactive PEMF device, delivers no PMF 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.
All-Cause Mortality
Sham PEMF Device PEMF Device
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sham PEMF Device PEMF Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sham PEMF Device PEMF Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/3 (0.00%) 
Early termination leading to small numbers of subjects analyzed
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
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