Trial Outcomes & Findings for Pulsed Electromagnetic Fields (PEMF) and Post-Axillary Surgery Morbidity (NCT NCT01255631)

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

22 participants

Primary outcome timeframe

2 weeks

Results posted on

2015-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	13	9
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	9	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study poor enrollment, no data analyzed	9	6

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham PEMF Device n=4 Participants Sham PEMF Device: Inactive PEMF device, delivers no PMF	PEMF Device n=3 Participants 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 n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Sham PEMF Device n=4 Participants Sham PEMF Device: Inactive PEMF device, delivers no PMF	PEMF Device n=3 Participants 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.
Pain Level on Visual Analog Scale	3.878 units on a scale Standard Deviation 2.811	5.239 units on a scale Standard Deviation 2.979

SECONDARY outcome

Timeframe: Post-Operative Day 1 & 2 (2 Days)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Sham PEMF Device n=4 Participants Sham PEMF Device: Inactive PEMF device, delivers no PMF	PEMF Device n=3 Participants 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.
Jackson Pratt (JP) Drain Output	136.5 milliliters (mL) Standard Deviation 74.633	85.333 milliliters (mL) Standard Deviation 39.272

SECONDARY outcome

Timeframe: Pre- and Post-Operative Period

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre- and Post-Operative Period

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre- and Post-Operative Period

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post-Operative Period

Population: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Sham PEMF Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PEMF Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christine Rohde

CUMC Plastic Surgery

Phone: 212-342-3707

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place