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临床试验/NCT03284008
NCT03284008已完成不适用

Assessing Efficacy of Axillary Web Syndrome Treatment

European Institute of Oncology2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年7月16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
发起方
入组人数
60
试验地点
2
主要终点
Range of motion change overtime

研究概览

简要总结

The aim of this study is verify the effectiveness of manual maneuver associated with stretching exercises in the treatment of Axillary Web Syndrome.

详细描述

Axillary Web Syndrome (AWS) is one of the short / medium-term sequela of surgical treatment for breast cancer with axillary dissection (AD) or sentinel lymph node biopsy (SLNB), with incidence reported in literature between 28% and 72%. AWS could be described as a thrombophlebitis of veno-lymph vessels due to a trauma of the region subjected to surgery, with the same characteristics of "Mondor's disease" diagnosed in post-traumatic and surgical areas where is a large presence of veno-lymphatic capillaries.

The syndrome onset occur in approximately 2-4 weeks after the surgery and its complete regression happen in 3-6 months after the onset. The clinical signs frequently described are pain and tension during movement in the axillary region, elbow, forearm and wrist, following the arm lymphatic pathway. Moreover, patients report difficulties in moving the arm into activities that require a moderate range of motion and could feel and see in the affected arm cords similar to a tendon. Even if the impairment can cause disability for a limited period of time, rehabilitation is usually advice to prevent further complications such as frozen shoulder, articular impeachment syndrome and long-term chronic pain, complications that could worsen patient's quality of life with a significant increase in costs and time to recovery.

Nowadays there are no studies in the literature that demonstrate the effectiveness of physiotherapy in AWS, with just case reports describing different treatments techniques, without a scientifically defined experimented rehabilitation protocol.

This experimental, monocentric, randomized clinical trial wants verify the effectiveness of a manual maneuver associated with stretching exercises in the treatment of AWS.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients with age between 18 and 70 years old
  • Axillary dissection with or without plastic reconstruction with prothesis
  • Positive diagnose of axillary web syndrome.
  • Patients without mental or psychological problems which could affect the proposed treatment execution.
  • Signed informed consensus form.

排除标准

  • Chronic or acute upper limb pathology which could affect the proposed treatment execution.
  • Patients with mental or psychological problems which could affect the proposed treatment execution.
  • Plastic reconstruction with abdominal (DIEP or TRAM) and dorsal grafts or with expander.
  • Previous head and neck, sentinel lymph node biopsy or axillary dissection surgery.
  • Previous breast, axillary or head and neck radiotherapy.
  • Halsted mastectomy.
  • Previous lymphedema.
  • Bilateral axillary dissection surgery
  • Physiotherapy treatment execute outside hospital during the study.

研究组 & 干预措施

Manual manoeuver + stretching

Experimental

Patients will receive a manual manoeuver treatment and education to perform stretching exercises at home.

干预措施: Manual manoeuver + stretching (Other)

stretching exercise

Active Comparator

Patients will receive education to perform stretching exercises at home.

干预措施: stretching exercise (Other)

结局指标

主要结局

Range of motion change overtime

时间窗: Baseline, 7 days and 30 days after baseline measure

Range of motion measured with a handheld goniometer, in degrees.

次要结局

  • Lymphedema assessment(3 years after baseline measure)

研究者

发起方
European Institute of Oncology
申办方类型
Other
责任方
Sponsor

研究点 (2)

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