Effectiveness of Physical Therapy on Axillary Web Syndrome After Breast Cancer Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change from baseline in Subjective pain at one month (post-intervention); and 3 and 6 months post-intervention
研究概览
简要总结
Objective: To determine the effectiveness of physical therapy on the axillary web syndrome in improving pain, reducing swelling and increasing mobility of the shoulder. Design: randomized single-blinded controlled trial. Follow-up: five physical therapy assessments: pre-intervention; post-intervention, 3 months post-intervention, 6 months post-intervention. Participants: Eighty consecutive women diagnosed with axillary web syndrome after undergoing unilateral breast cancer surgery with ALND or SLND at the Prıíncipe de Asturias Hospital in Alcalà de Henares, Madrid (Spain). Randomization: women will be randomly assigned to two groups by EpiData 3.1 software. Interventions: Physical Therapy group: Physical Therapy composed of manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active and action-assisted arm exercises; Control group: standard progressive active and action-assisted arm exercises. 9 physical therapy sessions.
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
- 否
入选标准
- •Unilateral breast cancer;
- •Breast surgery with lymphadenectomy and / or sentinel lymph node biopsy;
- •Axillary web syndrome in chest and / or upper limb of the operated side;
- •Consent to participate in the study;
- •No contraindications for physical therapy (infection, metastasis);
排除标准
- •Cognitive impairment;
- •Visual impairment for reading;
- •Lymphedema;
- •Bilateral breast cancer;
- •Systemic disease (metastases),
- •Infection;
- •Locoregional recurrence.
结局指标
主要结局
Change from baseline in Subjective pain at one month (post-intervention); and 3 and 6 months post-intervention
时间窗: Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention
Visual Analogue Scale
次要结局
- Change from baseline in Range of shoulder motion at one month (post-intervention); and 3 and 6 months post-intervention(Pre-intervention (baseline); Post-intervention (one month from baseline); and 3 and 6 months post-intervention)
研究者
Maria Torres Lacomba
Professor
University of Alcala