Effectiveness of Cohesive Bandage on Axillary Web Syndrome After Breast Cancer Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change from baseline in Subjective pain
研究概览
简要总结
Objective: To determine the effectiveness of cohesive bandage on the axillary web syndrome in improving pain, reducing swelling and increasing mobility and functionality of the shoulder. Design: randomized single-blinded controlled trial. Follow-up: five physical therapy assessments: pre-intervention; post-intervention, 3 and 6 months post-intervention post-intervention. Participants: 90 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: Control 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 arm therapeutic exercises; Intervention group: progressive active arm therapeutic exercises with cohesive bandage.
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
- Double (Investigator, 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 upper limb of the operated side;
- •Consent to participate in the study;
- •No contraindications.
排除标准
- •Cognitive impairment;
- •Visual impairment for reading;
- •Lymphedema;
- •Bilateral breast cancer;
- •Systemic disease (metastases),
- •Infection;
- •Locoregional recurrence.
研究组 & 干预措施
CONTROL GROUP
Control group includes physical therapy protocol 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 arm therapeutic exercises.
干预措施: Manual drainage & arm therapeutic exercise (Other)
COHESIVE BANDAGE GROUP
Cohesive bandage is a self-adherent lightweight bandage, made of a porous nonwoven polyester material. A single self-adherent inelastic bandage will be directly applied at full stretch on cleaned and dried skin (10cm 3M CobanTM Minnesota Mining and Manufacturing Co, United States) in a spiral method around the limb, starting at the hand and a layer overlap of 50%, so that the greatest compression was located at the distal points, gradually decreasing toward the proximal shoulder part. Cohesive latex-free bandages will be available for those allergic women. Women will do progressive active arm therapeutic exercises with bandaging.
干预措施: Cohesive bandaging & arm therapeutic exercise (Other)
结局指标
主要结局
Change from baseline in Subjective pain
时间窗: 4 assessments to evaluate change from baseline: at baseline, after the intervention period (6 weeks from baseline), 3 and 6 months after the intervention.
Visual Analogue Scale (0-10 cm)
次要结局
- Change from baseline in perceived shoulder disability(4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention.)
- Change from baseline in Range of shoulder motion(4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention.)
- Change from baseline in QoL(4 assessments to evaluate change from baseline: at baseline, and after the intervention period (6 weeks from baseline), 3 months and 6 months after the intervention.)
研究者
Maria Torres Lacomba
Principal investigator & Professor
University of Alcala