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临床试验/NCT02250898
NCT02250898已完成不适用

Massage for Pain and Mobility in Post-Breast Surgery Patients

MetroHealth Medical Center2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2014年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Change in self reported pain pre and post study

研究概览

简要总结

The aims of this study are to determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area in reducing self-reported pain and increasing mobility among patients who have undergone a mastectomy or other breast surgery compared to a control group receiving global relaxation massages.

详细描述

Post-operative breast surgery patients may face an array of complications. Breast surgery can include biopsy, lumpectomy, mastectomy or some type of reconstruction (Drackley 2012). Chronic pain and lack of mobility in the chest and/or shoulder are two of the more common and persistent issues in this population, however it is still unclear as to how many actually suffer from these (Wallace 1996). Current treatment for each of these usually includes prescribed narcotic pain medication and/or some physical therapy, the first being a treatment with many side effects, the latter being quite expensive. Global and integrated massage techniques have been used as a way of decreasing stress, anxiety, and some self-reported pain, however a targeted massage technique geared towards the breast/chest/shoulder region has not been rigorously evaluated (Drackley 2012). Myofascial massage has been shown to be an effective treatment for other post-surgical patients in reducing pain and increasing mobility, but efficacy has yet to be shown specifically in post-breast surgery patients (FitzGerald 2009). If proven effective, myofascial massage could be used as an inexpensive and non-invasive addition to current pain and mobility treatment (Cassileth 2004).

Specific Aims

Aim A.

Determine the effectiveness of myofascial massage specific to the breast/chest/shoulder area in reducing self-reported pain among patients who have undergone a mastectomy or other breast surgery.

Aim B.

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
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 79 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age range 21-79 years of age
  • Breast and/or axillary surgery
  • 2-18 months post-operative
  • Meets minimum pain and/or lack of mobility threshold as determined by survey
  • Ability to give informed consent
  • Ability to complete adherence task
  • Benign or malignant forms of disease

排除标准

  • History of blood clots
  • Mentally incompetent
  • Non-English speaking
  • Infected sites or open wounds
  • Currently lactating
  • Currently receiving massage therapy for breast surgery
  • Currently taking anticoagulants including:
  • Cilostazol Clopidogrel Ticlopidine Prasugrel Ticagrelor Dipyridamole Warfarin Dabigatran Rivaroxaban Apixaban Abciximab Eptifibatide Tirofiban Dalteparin Enoxaparin Fondaparinux Heparin Tinzaparin Argatroban Bivalirudin Lepirudin

研究组 & 干预措施

Experimental/Myofascial

Experimental

The intervention group will receive Myofascial Massage Therapy specific to breast/chest/shoulder of the affected side(s). These massages will include a variety of techniques specifically aimed at reducing pain, inflammation, and tissue sensitivity while also increasing mobility by breaking up scar tissue and thick fibrosis. The intervention massages will include the following specific techniques: skin glide, j stroking, vertical stroking, strumming, fascial stretch, circular friction, deep fascial restriction release, arm pull, side latissimus dorsi stretch, twisting, moist heat application, cold therapy, and lymphatic drainage. These massages will be twice a week at 30 minutes per massage for a period of 2 months after study enrollment.

干预措施: Myofascial Massage Therapy (Other)

Control/Global Relaxation

Active Comparator

The control group will receive a general full body massage referred to as a Global Relaxation massage. The massage technique used here will be relaxation massage, avoiding the breast/chest/arm area. This includes light kneading and stroking in order to restore a sense of well- being. The relaxation massage will also be twice a week at 30 minutes per massage for a period of 2 months, avoiding the area of the affected shoulder/shoulders. In this way they are still being seen and touched by a massage therapist, without receiving the intervention treatment.

干预措施: Global Relaxation Massage (Other)

结局指标

主要结局

Change in self reported pain pre and post study

时间窗: 2 months

Self report survey of current pain type and intensity will be given at the beginning of enrollment and then again after the 2 month study period ends. Pain scores will be measured pre and post.

次要结局

  • Change in self reported mobility pre and post study(2 months)

研究者

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

Ash Sehgal

Director, Center for Reducing Health Disparities

MetroHealth Medical Center

研究点 (2)

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