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临床试验/NCT03389204
NCT03389204已完成不适用

Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention- Randomized Control Trial

Assuta Medical Center2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
2
主要终点
Shoulder pain

研究概览

简要总结

Surgical treatments can cause late effects influencing activity of daily living, physical activity, and overall health. Late effects include persistent pain reported by 30 - 50% of women that underwent breast operations, restrictions of arm and shoulder movement were reported in 35% of patients, lymphedema in 15 - 25% of women who undergo axillary lymph node dissection and in about 6% of women who undergo sentinel lymph node biopsy. Lymphedema results in physical impairments including compromised function, diminished strength, fatigue, and pain in the affected arm . The axillary web syndrome is a self-limiting and frequently overlooked cause of significant morbidity in the early postoperative period after breast cancer, which is characterized by axillary pain that runs down the medial arm, limited shoulder range of motion (ROM) .

Physiotherapy and exercise in the postoperative period can result in a significant improvement in shoulder ROM in women treated for breast cancer, Additionally, exercises are an effective intervention to improve quality of life, cardiorespiratory fitness, physical functioning and fatigue in breast cancer patients. However, in the postoperative period consideration should be given to the early implementation of exercises because of the potential for seroma and increases in wound drainage volume and duration.

There is limited evidence on the influence of postoperative physiotherapy intervention, and instruction program on upper limb range of motion and return to physical activity divided by the type of surgery and regarding complications.

详细描述

Aim The aim of this study is to evaluate the influence of early postoperative physical therapy program on upper-limb function and returning to physical activity in the first 6 months following surgery.

Hypotheses

  • Early physical activity performed post-operative will improve ROM and therefore, will help women after breast surgeries to return faster to their routine physical activity and by that promote physical health.
  • Early postoperative physical therapy is safe when the program for is tailored to the type of surgery.

Methods

Study design Parallel group prospective randomized controlled clinical trial. Two surgical department's including general surgery department and genecology department in Assuta hospital, Tel Aviv, Israel

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Participants were blinded to physical support or not

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosed with breast cancer, undergoing breast surgery,
  • Functional independence prior to the operation.
  • Ability to communicate in Hebrew.

排除标准

  • Cognitive disorders, patients unable to sign the consent form.
  • Back and spinal morbidity.
  • Fibromyalgia or chronic pain disorders.
  • Neurological disorders.
  • Renal failure with the need for dialysis.
  • Lymphedema prior to surgery.
  • History of breast surgery.
  • Shoulder surgery or shoulder injuries with limited ROM.
  • Ischemic heart disease, heart failure and radical heart insufficiency.
  • Radical mastectomy, LD and DEIP reconstruction, exchange breast prosthesis.

结局指标

主要结局

Shoulder pain

时间窗: 6 mnth

The intensity of pain and chronological modification will be monitored

次要结局

未报告次要终点

研究者

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

Sergio Gabriel Susmallian

Head of the Department of General Surgery

Assuta Medical Center

研究点 (2)

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