NCT06278298进行中（未招募）不适用
Different Levels of Energy of Extracorporeal Shock Wave Therapy in Post Masrectomy Lymphedema
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- lymphedema volume
研究概览
简要总结
to investigate the effectiveness of different dosages of ECSW in the treatment of post mastectomy lymphedema volume and quality of life (Qol)
详细描述
The treatment program included two sessions per week for eight weeks. This study was approved by the ethical committee faculty of Physical Therapy Cairo University. All patients signed a consent form involves their agreement to participate in this study.
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 (Participant)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Criteria of selecting the patients from hospital included the following;
- •Their ages ranged from 30 to 50 years.
- •All patients were examined carefully by physician before the study procedure.
- •All patients were free from any other pathological conditions or histories of other health abnormalities except arm lymphedema.
- •They had undergone radical or modified radical mastectomy with axillary lymph node dissection with or without radiotherapy intervention.
- •Only ambulant subjects without any aides will be selected.
- •The degree of lymphedema in all subjects was grade 2 to 3 according to the classification of Foldi.(Foldi et al., 2006), (Appendix II ).
- •All patients will be medically stable.
- •Each patient will sign a consent form which in that insures her eligibility in the study.
- •All patients were treated by the same doctor and physiotherapist.
排除标准
- •The subjects had been excluded from the study if they met one of the following criteria;
- •The patients had recurrent malignancy, active infection, and clinical evidence of obstructive venous diseases.
- •Patients contraindicated to ESWT due to bilateral, acute, and chronic inflammation as well as due to metastasis and poor skin condition were excluded.
- •The patients had neurological or orthopedic problems, and diabetes.
- •Patients with primary lymphedema.
- •Cardiopulmonary disease which decrease the patient activites.
研究组 & 干预措施
Group A
Experimental
Shockwave
干预措施: Shockwave (Device)
Group B
Experimental
Shockwave
干预措施: Shockwave (Device)
Group C
Placebo Comparator
CDT
干预措施: CDT (Other)
结局指标
主要结局
lymphedema volume
时间窗: two months
tape measurment
skin thickness of the arm
时间窗: two months
ultrasonography
次要结局
未报告次要终点
研究者
Christina Sabry
Senior Physical Therapist
Cairo University
研究点 (2)
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