Pulsed Electromagnetic Fields (PEMF) and Post-Axillary Surgery Morbidity
Condition: Shoulder Symptoms After Lymph Node Dissection
Intervention: PEMF Device; Sham PEMF Device
Intervention description: 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.; Inactive PEMF device, delivers no PMF
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.