- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01255631
Pulsed Electromagnetic Fields (PEMF) and Post-Axillary Surgery Morbidity
Use of Pulsed Electromagnetic Fields in Reducing Arm and Shoulder Complaints in Breast Cancer Patients After Lymph Node Dissection
The most important prognostic indicator for the breast cancer patient is the axillary lymph node status. With the introduction of the sentinel lymph node biopsy, many women were spared the morbidity of a full axillary lymph node dissection(ALND) while having the axillary nodes assessed with a low false negative rate. Approximately 30% of women who undergo ALND experience shoulder/arm morbidity including numbness, pain, weakness and decreased range of motion. In addition, the sentinel lymph node dissection (SLND) held the promise that women with early stage breast cancer would be able to avoid the dreaded morbidity associated with axillary lymph node dissections including lymphedema, decreased range of motion and pain. Since the adoption of SLN, numerous papers have documented that SLN is superior to ALND. However, patients who undergo SLN still have a significant amount of pain with this procedure. There are few published studies which objectively assess the subjective and objective symptoms of SLND.
Pulsed electromagnetic fields (PEMF) have been shown to be effective in the treatment of fractures and spinal fusion, relief of pain in acute sprains and whiplash injuries, improvement of skin blood flow, healing of venous stasis ulcers, and reduction of postmastectomy lymphedema. Indeed, radiofrequency PEMF devices are FDA approved for pain and edema relief. PEMF devices are economical and disposable, and can be incorporated unobtrusively in standard post-op dressings. We have recently reported, in a double-blind, placebo-controlled study on breast reduction, that post-op PEMF therapy produced a significant decrease in pain and pain medication use, along with a concomitant decrease in IL1-beta in the wound bed.1 The current pilot study will be designed to determine if PEMF treatment, given in addition to standard of care, can reduce post-operative discomfort and morbidity after lumpectomy and SLND, or lumpectomy and ALND. Lumpectomy and ALND/SLND patients enrolled in the double-blind, placebo-controlled study will undergo standard surgery, but will be randomized to one of two groups: the treatment group with a PEMF coil placed around the arm and the control group with a coil that delivers no PMF. We expect postoperative pain to be reduced in the PEMF-treated patients as well as improved arm mobility and strength. The use of PEMF might reduce the need for narcotic pain medications and their side effects of sedation, nausea, and vomiting. It may also reduce costs related to arm morbidity.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Inclusion criteria include patients undergoing axillary lymph node dissection or sentinel lymph node dissection for breast cancer. Patients undergoing lumpectomy with the axillary surgery will be included.
Exclusion Criteria:
- Patients undergoing mastectomy with the axillary surgery will be excluded.
- Patients with prior axillary radiation or prior arm impairment will be excluded.
- Patients with pacemakers will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Sham PEMF device
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Inactive PEMF device, delivers no PMF
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Active Comparator: PEMF Device
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Level on Visual Analog Scale
Time Frame: 2 weeks
|
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).
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2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Jackson Pratt (JP) Drain Output
Time Frame: Post-Operative Day 1 & 2 (2 Days)
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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.
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Post-Operative Day 1 & 2 (2 Days)
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Patient Self-Assessment of Shoulder and Arm Symptoms Before and After PEMF
Time Frame: Pre- and Post-Operative Period
|
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.
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Pre- and Post-Operative Period
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Clinical Assessment of Shoulder and Arm Symptoms Before and After PEMF
Time Frame: Pre- and Post-Operative Period
|
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.
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Pre- and Post-Operative Period
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Lymphedema
Time Frame: Pre- and Post-Operative Period
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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.
|
Pre- and Post-Operative Period
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Narcotic Pain Medications
Time Frame: Post-Operative Period
|
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.
|
Post-Operative Period
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Rohde C, Chiang A, Adipoju O, Casper D, Pilla AA. Effects of pulsed electromagnetic fields on interleukin-1 beta and postoperative pain: a double-blind, placebo-controlled, pilot study in breast reduction patients. Plast Reconstr Surg. 2010 Jun;125(6):1620-1629. doi: 10.1097/PRS.0b013e3181c9f6d3.
- Helms G, Kuhn T, Moser L, Remmel E, Kreienberg R. Shoulder-arm morbidity in patients with sentinel node biopsy and complete axillary dissection--data from a prospective randomised trial. Eur J Surg Oncol. 2009 Jul;35(7):696-701. doi: 10.1016/j.ejso.2008.06.013. Epub 2008 Oct 5.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AAAE3803
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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