Trial Outcomes & Findings for Use of Pulsed Electromagnetic Fields (PEMF) After Breast Reconstruction Surgery (NCT NCT01262599)
NCT ID: NCT01262599
Last Updated: 2018-09-25
Results Overview
We will record postoperative pain, as reported by the patient and quantified by a standardized visual analog scale (VAS), with written descriptions at 12 hours post-op and assess that pain level in comparison with previous timepoint pain levels, such as 1 hour post-op. The VAS pain scale ranges from 0 (no pain) to 10 (worst possible pain). Higher scores indicate more pain and lower scores indicate less pain. The mean VAS score at 12 hours is reported for each group, active or placebo.
COMPLETED
PHASE4
32 participants
12 hours
2018-09-25
Participant Flow
Recruited from medical offices of two participating plastic surgeons.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Pulsed Electromagnetic Fields (PEMF) After Breast Reconstruction Surgery
Baseline characteristics by cohort
| Measure |
Sham PEMF Device
n=16 Participants
Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
|
PEMF Device
n=16 Participants
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
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 9.1 • n=39 Participants
|
51.1 years
STANDARD_DEVIATION 9.7 • n=41 Participants
|
52.3 years
STANDARD_DEVIATION 9.3 • n=35 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
32 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=39 Participants
|
16 participants
n=41 Participants
|
32 participants
n=35 Participants
|
|
Body Mass Index (BMI)
|
25.1 kg/m2
STANDARD_DEVIATION 3.1 • n=39 Participants
|
24.5 kg/m2
STANDARD_DEVIATION 3.4 • n=41 Participants
|
24.8 kg/m2
STANDARD_DEVIATION 3.2 • n=35 Participants
|
PRIMARY outcome
Timeframe: 12 hoursWe will record postoperative pain, as reported by the patient and quantified by a standardized visual analog scale (VAS), with written descriptions at 12 hours post-op and assess that pain level in comparison with previous timepoint pain levels, such as 1 hour post-op. The VAS pain scale ranges from 0 (no pain) to 10 (worst possible pain). Higher scores indicate more pain and lower scores indicate less pain. The mean VAS score at 12 hours is reported for each group, active or placebo.
Outcome measures
| Measure |
Sham PEMF Device
n=16 Participants
Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
|
PEMF Device
n=16 Participants
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.
|
|---|---|---|
|
Pain Score Measured by Visual Analog Scale
|
3.48 units on a scale
Standard Deviation 0.61
|
1.67 units on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: data reported at 24 hours postop
We will record the amount of pain medication used at twelve hour intervals for the duration of the hospital stay. Pain medications will be converted to oxycodone/acetaminophen equivalents for statistical analysis
Outcome measures
| Measure |
Sham PEMF Device
n=16 Participants
Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
|
PEMF Device
n=16 Participants
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.
|
|---|---|---|
|
Number of Narcotic Pain Medications
|
34 pills
Standard Deviation 2.8
|
20 pills
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: data reported at 24 hours postop
Concentration of the cytokines IL1-beta in the wound bed. Exudates will be collected from standard Jackson-Pratt #10 drains until the patient is discharged. IL1-beta is an early central proinflammatory cytokine that induces cyclooxygenase, an enzyme responsible for prostaglandin synthesis. A decrease in IL1-beta correlates with a decrease in pain. Cytokines and growth factors may contribute to more rapid post-op pain reduction and healing.
Outcome measures
| Measure |
Sham PEMF Device
n=16 Participants
Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
|
PEMF Device
n=16 Participants
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.
|
|---|---|---|
|
Levels of Cytokines
|
320 pg/ml
Standard Deviation 36
|
168 pg/ml
Standard Deviation 17
|
Adverse Events
Sham PEMF Device
PEMF Device
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Christine Rohde
Columbia University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place