Effectiveness of Complete Decongestive-versus Non-pneumattic- Compression Therapy in Patients With Post-mastectomy Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Pain measured by visual analogue scale.
研究概览
简要总结
The aim of the study is to compare the effectiveness of Complete Decongestive Therapy and Non-Pneumatic Compression Therapy, both combined with routine physical therapy, in reducing pain and edema volume, improving range of motion, respiratory function, inflammatory markers, and overall quality of life in patients with post-mastectomy lymphedema.
详细描述
Post-mastectomy lymphedema (PML) is a chronic, progressive, and disabling complication affecting breast cancer survivors due to disruption of lymphatic drainage following surgery or radiotherapy. It leads to swelling, pain, restricted range of motion, recurrent infections, and reduced quality of life.
Complete Decongestive Therapy (CDT) - a multimodal approach involving manual lymphatic drainage, compression bandaging, skin care, and exercise - is currently the gold standard for lymphedema management. However, CDT is time-consuming, therapist-dependent, and often poorly tolerated or inaccessible for long-term self-management.
Non-Pneumatic Compression Therapy (NPCD) is a newer, portable, and wearable device that provides gradient sequential compression while allowing mobility and daily activity during treatment. It potentially improves adherence, comfort, and patient satisfaction.
Limited comparative research exists evaluating the relative effectiveness of CDT and NPCD in post-mastectomy lymphedema. This study aims to fill this gap and determine which approach produces superior clinical and functional outcomes.
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
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females with age between 30 to 60 years. (Monticciolo et al., 2021)
- •Females with unilateral mastectomy post three months of surgery. (Shen et al., 2023) 21
- •A volume difference to the circumferential measurements between the affected and unaffected upper extremities of more volume difference>10%.
- •Completed chemotherapy and/or radiation therapy. (Borman, Yaman, Yasrebi, İnanlı, & Dönmez, 2022)
排除标准
- •xclusion Criteria:
- •Systemic disorders that might contraindicate the use of sequential compression therapy i.e. chronic kidney disease with renal failure, Congestive heart failure, neurological disorders, respiratory disorders.
- •Presence of active cellulitis, open and partially healed wounds.
- •Patients with lipedema
- •Active or recurrent cancer (defined as < 3 months since completion of cancer therapy)
- •An acute infection within the previous 4 weeks
- •Active venous thromboembolic edema
- •Pregnant women and women who are planning or nursing at study entry.
- •Patients who had participated in any clinical trial of an investigational substance or device during the previous 30 days
- •Potential patients with a cognitive or physical impairment that would interfere with appropriate use of the device. (Rockson, Whitworth, et al., 2022)
研究组 & 干预措施
Complete Decongestive Therapy (CDT) and Routine Physical Therapy
Group A: Complete Decongestive Therapy (CDT) and Routine Physical Therapy:
Manual Lymphatic Drainage (MLD)
-
Duration: 30 minutes/session
-
Frequency: 5 days/week
-
Technique: Performed by a certified lymphedema therapist
-
Areas: Neck, axilla, trunk, and affected limb
-
Total treatment time: 8 weeks 2. Compression Bandaging
-
Type: Multi-layer short-stretch bandaging
-
Application: After MLD in each session
-
Worn Duration: 22-23 hours/day
-
Reapplied Daily: Yes 3. Skin Care
-
Duration: 10 minutes/session
-
Components:
-
Inspection of skin
-
Use of pH-neutral moisturizers
-
Infection prevention education 4. Exercise Therapy (Routine Physiotherapy)
-
Type: Gentle, active ROM and resistance exercises (e.g., shoulder mobility, grip strengthening)
-
Duration: 20 minutes/session
-
Progression: Gradually increase intensity over 8 weeks
干预措施: Complete Decongestive therapy (Other)
Group B: Non-pneumatic compression device (NPCD) and Routine Physiotherapy (RPT)
Subjects will be taught how to apply the device themselves, including placement, duration of use, and turning it on/off. All subjects will be instructed to wear the device for up to 40 minutes per day and to continue their usual activity during use. Routine Physical Therapy:
- Type: Gentle, active ROM and resistance exercises (e.g., shoulder mobility, grip strengthening)
- Duration: 20 minutes/session
- Progression: Gradually increase intensity over 8 weeks
干预措施: Non Pneumatic compression device (Device)
结局指标
主要结局
Pain measured by visual analogue scale.
时间窗: Assessment will be done at baseline, 4th week and 8th week.
Lymphedema-related symptoms (pain, pressure, heaviness and hardness). The visual analogue scale (VAS) is a validated, subjective measure for acute or chronic pain. Scores are based on self-reported measures of symptoms from 0-10 score. With zero "no pain" and 10 "worst pain". Test-rater reliability has been shown to be good, but higher among literate (r= 0.94, P=0.001) than illetrate patients (r= 0.71, P=0.001).
次要结局
- Edema volume by water displacement method(Assessment will be done at baseline, 4th week and 8th week.)
- Quality of life measured by Lymphoedema Functioning Disability and health questionnaire for the upper limb (Lymph-ICF-UL)(Assessment will be done at baseline, 4th week and 8th week)
- Functional mobility measured by upper extremity functional index(Assessment will be done baseline, 4th week and 8th week)
- Upper limb range of motion measured by goniometer(Assessment will be done at baseline, after 4th week and 8th week)
- Respiratory functions measured by spirometer(Assessment will be done baseline, 4th week and 8th week)
- Inflammatory markers CK, CRP, IL-6, and TNF-α(Assessment will be done at baseline, after 4th week and 8th week)
研究者
Sahar Fatima
Sahar Fatima
Lahore University of Biological and Applied Sciences