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

Phase 4

Terminated

• Conditions: Shoulder Symptoms After Lymph Node Dissection
• Interventions: Device: Sham PEMF Device; Device: PEMF Device

• Registration Number: NCT01255631
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-06
• Study First Posted: 2010-12-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2015-02-05
• Status Verified: 2015-09
• Results First Submitted QC: 2015-09-15
• Last Update Submitted: 2015-09-15
• Results First Posted: 2015-10-16
• Last Update Posted: 2015-10-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 22

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham PEMF device	Sham PEMF Device	-
PEMF Device	PEMF Device	-

Primary Outcome Measures

Name	Time	Method
Pain Level on Visual Analog Scale	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).

Secondary Outcome Measures

Name	Time	Method
Jackson Pratt (JP) Drain Output	Post-Operative Day 1 & 2 (2 Days)	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.
Patient Self-Assessment of Shoulder and Arm Symptoms Before and After PEMF	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.
Clinical Assessment of Shoulder and Arm Symptoms Before and After PEMF	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.
Lymphedema	Pre- and Post-Operative Period	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.
Narcotic Pain Medications	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.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States