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临床试验/NCT05082597
NCT05082597已完成不适用

Clinical Outcome of Extracorporeal Shock Wave Therapy in Patient With Axillary Web Syndrome-A Pilot Study

Taichung Veterans General Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年10月13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
20
试验地点
2
主要终点
Pain score

研究概览

简要总结

Axillary web syndrome(AWS) is common complication of breast cancer surgery. Overall, AWS affects more than a half of the patient receiving axillary lymph node dissection. The symptoms of AWS include pain, limited function and range of motion. Geater risk of secondary lymphedema was found if the patient developed AWS during the first postoperative year.

ESWT was used for treating myofascial pain for decades. Low energy ESWT combined with complex decongestive therapy had a benefit on shoulder joint ROM and skin thickness improvement in patients with BCRL in recently studies. Investigators wonder if ESWT can also be applied to patients with axillary web syndrome for increasing ROM and relieving pain.

The aim of this study was to evaluate the therapeutic effects of low energy ESWT in patients with axillary web syndrome.

详细描述

Although the anticipated enrollment was 30 participants, the study was completed with 20 participants due to early attainment of statistical significance and recruitment feasibility.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Axillary web syndrome patient
  • Unilateral breast cancer and received related operation(mastectomy/ALND/SLND)
  • Completion of beast related chemotherapy or radiotherapy
  • Age with 20-65 years old

排除标准

  • Ongoing metastasis or recurrence of the breast cancer
  • Other cancer history
  • Lymphatic transplantation or reconstruction
  • Wound, infection or trauma over affected arm
  • Coagulopathy or poor circulation
  • Oral anticoagulant using

结局指标

主要结局

Pain score

时间窗: 2 months

Visual Analogue Scale (0-10 points, higher score represented higher degree of pain)

Shoulder range of motion

时间窗: 2 months

Flexion, extension, external rotation, internal rotation, abduction over upper limbs

次要结局

  • Muscle strength(2 months)
  • Upper limb functional score(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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