Shoulder Symptoms After Lymph Node Dissection Clinical Trial
Official title:
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.
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment