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临床试验/NCT01255631
NCT01255631终止4 期

Use of Pulsed Electromagnetic Fields in Reducing Arm and Shoulder Complaints in Breast Cancer Patients After Lymph Node Dissection

Columbia University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
4 期
状态
终止
入组人数
22
试验地点
2
主要终点
Pain Level on Visual Analog Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Pain Level on Visual Analog Scale

时间窗: 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).

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christine Hsu Rohde, MD

Assistant Professor of Clinical Surgery

Columbia University

研究点 (2)

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