Effectiveness of Extracorporeal Shockwave Therapy versus Complex Decongestive Therapy in Breast Cancer Related Lymphedema: A Single Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Arm circumference using measuring tape. Shoulder pain and disability using Shoulder pain and Disability Index
研究概览
简要总结
Effectiveness of Extracorporeal Shockwave Therapy Versus Complex Decongestive Therapy in Breast Cancer-Related Lymphedema: A Single-Blinded Randomized Controlled Trial
Aim of Study: To compare the effectiveness of Extracorporeal Shockwave Therapy Versus Complex Decongestive Therapy for Breast Cancer-Related Lymphedema
Null Hypothesis: There will be no significant difference between the effect of Extracorporeal Shockwave Therapy and Complex Decongestive Therapy in terms of arm circumference, shoulder pain and disability, hand grip strength, quality of life and neuropathic symptoms in particpants with breast cancer related lymphedema.
Alternate hypothesis: There will be significant difference between the effect of Extracorporeal Shockwave Therapy and Complex Decongestive Therapy in terms of arm circumference, shoulder pain and disability, hand grip strength, quality of life and neuropathic symptoms in particpants with breast cancer related lymphedema.
Inclusion Criteria: 1. All referred cases of Breast cancer patients with lymphedema, aged 18 years and above 2. Lymphedema secondary to breast cancer treatment 3. Unilateral lymphedema
Exclusion criteria: 1. Metastatic cancer 2. Active leukemia 3. Acute inflammation and infection 4. Severe trauma or disruptive surgery to arm 5. Pregnancy, Breast feeding 6. Previously undergone CDT or any form of physical therapy within 3 months
A written informed consent will be obtained from the participants. A brief demographic data will be obtained from the subjects prior to assessment. Baseline assessment of the particpants will be done before the intervention. Then the particpants will be divided into two groups i.e. Extracorporeal Shockwave Therapy group (n=11) and Complex Decongestive Therapy group (n=11). Both groups will be treated 3 times a week for 3 weeks and data will be collected and analysed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- Female
入选标准
- •All referred cases of breast cancer patients with lymphedema, aged 18 years and above
- •Lymphedema secondary to breast cancer treatment
- •Unilateral lymphedema.
排除标准
- •Metastatic cancer
- •Active leukemia
- •Acute inflammation and infection
- •Severe trauma or disruptive surgery to arm
- •Pregnancy/Breast feeding
- •Previously undergone Complex Decongestive Therapy or any form of physical therapy within 3 months.
结局指标
主要结局
Arm circumference using measuring tape. Shoulder pain and disability using Shoulder pain and Disability Index
时间窗: Pre- Baseline | Post- after 1, 2 and 3 weeks
次要结局
- Hand grip strength using Dynamometer, Quality of life by using Functional Assessment of Cancer Therapy Breast (FACT-B) and Neuropathic symptoms by using Functional Assessment of Cancer Therapy/Gynaecologic Oncology-Neurotoxicity (FACT-GOG NTx)(Pre- Baseline)
研究者
Asmita Shrestha
KAHER Institute of Physiotherapy