Underwater Galvanic Stimulation by 4-Cell Bath on Lymphedema Post Mastectomy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Measuring pain intensity:
研究概览
简要总结
Sixty female patients with lymphedema post mastectomy, aged 30-55 years, will be selected from Minia Oncology Institute. The participants will be randomly distributed into two equal groups:
- Group A (CDT + Underwater Galvanic Stimulation group):
This group includes 30 patients who will receive underwater galvanic stimulation by 4-cell bath with CDT for 2 months (3times/week) in addition to their medical treatment. 2. Group B (CDT group):
This group includes 30 patients who will receive only CDT for 2 months (3times/week) in addition to their medical treatment.
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 (Participant)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •▪ Female patients with lymphedema post mastectomy
- •Aged 30-55 years
- •No history of cardiac or renal disease
- •No contraindications to electrotherapy
- •All patients enrolled to the study will have their informed consent.
排除标准
- •▪ Cardiac diseases.
- •Patients with active cancer
- •Patients with pacemakers or other implantable devices
- •Patients with a history of seizures or epilepsy
研究组 & 干预措施
Group A (CDT + Underwater Galvanic Stimulation group
This group includes 30 patients who will receive underwater galvanic stimulation by 4-cell bath with CDT for 2 months (3times/week) in addition to their medical treatment.
干预措施: underwater galvanic stimulation by 4-cell bath (Device)
Group A (CDT + Underwater Galvanic Stimulation group
This group includes 30 patients who will receive underwater galvanic stimulation by 4-cell bath with CDT for 2 months (3times/week) in addition to their medical treatment.
干预措施: Complete Decongestive Therapy (CDT): (Other)
Group B (CDT group):
This group includes 30 patients who will receive only CDT for 2 months (3times/week) in addition to their medical treatment.
结局指标
主要结局
Measuring pain intensity:
时间窗: 2 months
The Visual Analogue Scale (VAS) will be employed. This 10cm line, marked from "no pain"(zero) to "worst pain (10) imaginable," will be used to represent the pain continuum. Patients will be guided on how to interact with the VAS scale, ensuring clarity and ease of use.
Measuring the volume of a patient's upper limb:
时间窗: 2 months
Essential tools such as a flexible tape measure, marker pen or pencil, and a recording sheet will be collected. Measurements will be taken at specific anatomical landmarks every 4 cm, including the wrist, the midpoint of the forearm, and where the upper arm meets the shoulder. The tape measure will be applied snugly around the limb without tightening, ensuring consistency in tension. Both the affected and non-affected limbs will be measured for comparison, with a more than 10% volume increase indicating potential edem. Circumference measurements will be recorded to the nearest 0.1 cm without indenting the skin. The frustum of a cone formula will be used to estimate each arm segment's volume, with repeated measures for ongoing assessment.
Improvement in quality of life:
时间窗: 2 months
Assessed using the Lymphedema Quality of Life Questionnaire (LYMQOL).
Measuring pain intensity:
时间窗: 2 months
The Visual Analogue Scale (VAS) will be employed. This 10cm line, marked from "no pain"(zero) to "worst pain (10) imaginable," will be used to represent the pain continuum. Patients will be guided on how to interact with the VAS scale, ensuring clarity and ease of use.
Measuring the volume of a patient's upper limb:
时间窗: 2 months
Essential tools such as a flexible tape measure, marker pen or pencil, and a recording sheet will be collected. Measurements will be taken at specific anatomical landmarks every 4 cm, including the wrist, the midpoint of the forearm, and where the upper arm meets the shoulder. The tape measure will be applied snugly around the limb without tightening, ensuring consistency in tension. Both the affected and non-affected limbs will be measured for comparison, with a more than 10% volume increase indicating potential edem. Circumference measurements will be recorded to the nearest 0.1 cm without indenting the skin. The frustum of a cone formula will be used to estimate each arm segment's volume, with repeated measures for ongoing assessment.
Improvement in quality of life:
时间窗: 2 months
Assessed using the Lymphedema Quality of Life Questionnaire (LYMQOL).
次要结局
未报告次要终点
研究者
Aya Gamal Fawzy El-Sayed
Lecturer of Physical therapy for surgery
Cairo University