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临床试验/NCT06269523
NCT06269523已完成不适用

Effects of Rehabilitation and Kinesio Taping to Prevent Axillary Web Syndrome After Breast Cancer Surgery

University of Palermo2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年7月21日最近更新:
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
18
试验地点
2
主要终点
NRS Scale

研究概览

简要总结

Axillary web syndrome (AWS) is a complication associated with breast cancer surgery, characterized by pain, functional limitation of the shoulder and decreased quality of life. There are several physical treatment options to reduce pain and improve the functionality of the upper limb in women with AWS. This study evaluates the effectiveness of an early rehabilitation approach to prevent axillary web syndrome consisting in functional and proprioceptive re-education, manual lymphatic drainage and kinesio taping after breast cancer surgery.

详细描述

Axillary web syndrome (AWS), is a complication associated with breast cancer surgery, characterized by pain, functional limitation of the shoulder and decreased quality of life. The pain is localized in the axillary area and along the arm, with the limitation of the glenohumeral joint (GO) and the presence of one or more "cords" of tissue visible or palpable with the abduction of the GO, at the level of the axilla , which can extend medially up to the wrist. Incidence, etiopathogenesis and ideal treatment of this condition are not yet clear.

The literature provides several physical treatment options for AWS. Physical therapy is effective in reducing pain and improving the functionality of the upper limb. Manual lymphatic drainage is indicated in forms of lymphedema due to axillary lymphadenectomy. The commonly used rehabilitation treatment consists of functional re-education of the shoulder, neuromotor and proprioceptive re-education of the upper limb, lymphatic drainage. Kinesio taping is rarely used and not in association with rehabilitation. This study evaluates the effectiveness of an early rehabilitation approach consisting of functional and proprioceptive re-education, manual lymphatic drainage and kinesio taping after quadrantectomy and lymphadenectoma surgery for breast cancer in the prevention of axillary web syndrome.

At the U.O.C. of Functional Recovery and Rehabilitation Department of the Paolo Giaccone University Hospital in Palermo, have been enrolled 18 women between the ages of 45 and 65 years old with a diagnosis of breast cancer, underwent to quadrantectomy and axillary lymphadenectomy.

Patients have been randomly divided into two groups: treatment group, in which kinesio taping has been applied, associated with a rehabilitation protocol lasting 18 sessions of functional and proprioceptive re-education and manual lymphatic drainage; control group, subjected to 18 sessions of functional and proprioceptive re-education, manual lymphatic drainage.

Patients have been evaluated: one week after surgery (T0), at the end of the 18 sessions (T1) and 3 months after surgery (T2).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • women between the ages of 45 and 65 years with diagnosis of breast cancer underwent to quadrantectomy and axillary lymphadenectomy.

排除标准

  • metastatic disease, infections, past TVP, embolia.

研究组 & 干预措施

Treatment group

Active Comparator

18 sessions of functional and proprioceptive re-education, manual lymphatic drainage associated with kinesio taping.

干预措施: Kinesio taping, Lymphatic drainage (Other)

Control group

Active Comparator

18 sessions of functional and proprioceptive re-education and manual lymphatic drainage.

干预措施: Lymphatic drainage (Other)

结局指标

主要结局

NRS Scale

时间窗: one week after surgery(T0)- 5 weeks after surgery(T1)-12 weeks after surgery (t2)

NRS scale is an 11-point unidimensional scale that evaluates the intensity of pain in adults.The scale is composed of a horizontal line, with an interval ranging from 0 to 10, corresponding respectively to "no pain" and "worst pain imaginable".

Muscular strength of the upper limbs

时间窗: one week after surgery(T0)- 5 weeks after surgery(T1) -12 weeks after surgery (t2)

Distal strength can be semiquantitatively measured with a dynamometer. Dynamometry is a more precise measurement of the force that a muscle can exert and can allow for differences in strength to be recorded over time.

Joint excursion shoulder

时间窗: one week after surgery(T0)-5 weeks after surgery(T1)- 12 weeks after surgery (t2)

Range of motion of the shoulder taken with the use of a goniometer

次要结局

  • Constant Murley Score(one week after surgery(T0)- 5 weeks after surgery(T1)-12 weeks after surgery(t2))
  • upper limbs circumferenze (cyrtometry)(one week after surgery(T0)- 5 weeks after surgery(T1)- 12 weeks after surgery (t2))

研究者

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

Prof.ssa Giulia Letizia Mauro

Professor

University of Palermo

研究点 (2)

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