Effects of Extracorporeal Shock Wave Therapy (ESWT) and Low Intensity Laser Therapy (LLLT) Added to Complete Decongestive Therapy (CDT) on Extremity Volume, Pain Intensity, Functional Status and Quality of Life in Patients With Postmastectomy Stage 2 Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Extremity volumes
研究概览
简要总结
This study aimed to comparatively investigate the effects of ESWT and LLLT added to conventional CDT (which is the standard treatment for breast cancer-related lymphedema) on patients' limb volume, pain intensity, functional status and quality of life.
详细描述
after being informed study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility recruitments will get treatment into three groups in conventional complet decongestive therapy (CDT) program, electrocorporeal shock wave therapy (ESWT) combined with CDT program and low level laser therapy (LLLT) combined with CDT program
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with unilateral lymphedema after breast cancer-related surgery Patients whose chemotherapy and radiotherapy protocols have been completed Patients with stage 2 lymphedema according to ISL staging
排除标准
- •Patients with arm edema before breast cancer
- •Patients with ongoing chemotherapy and radiotherapy Those with metastatic breast cancer Patients with acute infection Patients with BMI >35 Patients with pregnancy Patients who have previously received KDT Patients with active cancer Patients with recurrence or metastasis of breast cancer on follow-up imaging Those with decompensated heart failure Those with kidney failure Patients with liver failure Patients with a history of deep vein thrombosis in the last 3 months Those who are allergic to the dressing materials to be applied Patients with active infection or open wound on their extremities Those with cognitive impairment Patients with sensory deficits Immobilized patients
研究组 & 干预措施
Complete Decongestive Therapy
22 breast cancer related lymphedema patients will received complete decongestive therapy
干预措施: Complete Decongestive Therapy (Other)
Complete Decongestive Therapy and ESWT
22 breast cancer related lymphedema patients will received ESWT added complete decongestive therapy
干预措施: Complete Decongestive Therapy (Other)
Complete Decongestive Therapy and ESWT
22 breast cancer related lymphedema patients will received ESWT added complete decongestive therapy
干预措施: ESWT (Device)
Complete Decongestive Therapy and LLLT
22 breast cancer related lymphedema patients will received LLLT added complete decongestive therapy
干预措施: Complete Decongestive Therapy (Other)
Complete Decongestive Therapy and LLLT
22 breast cancer related lymphedema patients will received LLLT added complete decongestive therapy
干预措施: LLLT (Device)
结局指标
主要结局
Extremity volumes
时间窗: Baseline, after three weeks
Upper limb Volume measured by perometer
次要结局
- Lymphedema Quality of Life-arm (LYMQOL-arm )(Baseline, after three weeks)
- Visual Anologue Scale -Pain (VAS)(Baseline, after three weeks)
- Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire(Baseline, after three weeks)
研究者
Bilge Büşra Ceylan
Medical Doctor
Ankara City Hospital Bilkent