The Effect of Complex Decongestive Physiotherapy Applied With Different Compression Pressures on Skin and Subcutaneous Tissue Thickness in Individuals With Breast Cancer-related Lymphedema: a Double-blinded Randomized Comparison Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- change from baseline residual volume with 4 weeks treatment and follow up
研究概览
简要总结
The goal of this randomised comparison study is to compare different bandage interface pressures in individuals with breast cancer related lymphedema
The main questions it aims to answer are:
- Is high or low bandage pressure effective in reducing edema and soft tissue thickness?
- do bandages applied with high or low bandage pressure comprimise sleep, comfort or subjective benefit from treatment?
Participants will recieve complex decongestive physiotherapy. Bandage will apply high or low pressure. Effects of high and low bandage interface pressures will compare
详细描述
The aim of this study was to evaluate the effect of compression bandage applied with different pressures on skin and subcutaneous thickness in individuals with breast cancer-related lymphedema.
individuals with stage 2 unilateral lymphedema participated in the study. Skin and subcutaneous thicknesses, extremity volumes, sleep quality, treatment benefit, comfort during treatment were evaluated respectively by ultrasound from 6 reference points as dorsum of hand, wrist volar, forearm dorsum, forearm volar, arm dorsum, arm volar, volumetric measurement, Pittsburgh Sleep Quality Index, Patient Benefit Index-Lymphedema, and visual analog scale. Complex decongestive physiotherapy was applied to individuals randomly divided into two groups: low (20-30 mmHg) and high bandage pressure (45-55 mmHg). Individuals were evaluated before treatment, at 1st, 10th session, end of treatment, and at 3 months follow-up.
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 (Participant, Outcomes Assessor)
盲法说明
radiologist who assessed soft tissue thickness assessment is masked and the patients did't know which group they belong to.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage 2 unilateral BCRL involving whole extremity according to ISL
- •To be volunteer.
排除标准
- •Acute deep vein thrombosis
- •Acute soft tissue infection
- •Peripheral artery disease in upper extremity
- •Systemic diseases with peripheral edema (kidney, hearth insufficiency etc.),
- •Allergy to materials used for treatment
- •Mental diseases effect cooperation
- •Sensory loss in the effected limb
- •Open wound in the effected limb.
结局指标
主要结局
change from baseline residual volume with 4 weeks treatment and follow up
时间窗: baseline, 1.day, 2 weeks, 4 weeks, 3 months (follow-up)
Limb volume was determined by the overflowing water method. The volumetric vessel was filled with tap water up to the overflow point of the vessel. Subjects were asked to lean forward while standing and slowly dip their arms into the water until the bar at the base of the volumetric cup snapped between the 2nd and 3rd fingers. During immersion, he was asked to avoid movements that could increase the transport of water. The overflowing water was first taken into a container. Then, the overflow water was calculated by transferring it to the measuring cups. The amount of overflowing water was recorded in ml. Measurements were made bilaterally.
change from baseline skin and subcutanetous thickness with 4 weeks treatment and follow up
时间窗: baseline, 1.day, 2 weeks, 4 weeks, 3 months (follow-up)
Evaluation of skin and subcutaneous tissue thickness and US evaluations were made by a radiologist using a 6-15 MHz linear probe with a LOGIQ US system. Skin and subcutaneous thickness were recorded as milimeter.
次要结局
- sleep quality(baseline, 4 weeks, 3 months (follow-up))
- Comfort(baseline, 4 weeks, 3 months (follow-up))
- Subjective benefit from treatment(4 weeks)
研究者
Elif Duygu
Research assistant
Abant Izzet Baysal University