Evaluation of Sympathetic Skin Response and Its Relationship With Clinical Response to Complex Decongestive Therapy in Patients With Postmastectomy Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This prospective observational single-center study aimed to evaluate sympathetic skin response (SSR) in patients with postmastectomy upper extremity lymphedema and to investigate the relationship between SSR parameters and clinical response to complex decongestive therapy (CDT).
Thirty female patients with breast cancer-related lymphedema and thirty healthy female controls were included in the study. All participants underwent autonomic nervous system assessment using SSR and R-R interval variability measurements and completed the Composite Autonomic Symptom Score-31 (COMPASS-31) questionnaire.
Patients in the lymphedema group received a standardized 3-week CDT program consisting of 15 treatment sessions. Clinical response to treatment was evaluated by calculating changes in lymphedema volume before and after treatment. Quality of life, upper extremity function, pain severity, and neuropathic pain symptoms were assessed using LYMQOL-Arm, QuickDASH, Numeric Rating Scale (NRS), and Leeds Assessment of Neuropathic Symptoms and Signs (LANSS).
详细描述
Breast cancer-related lymphedema is a chronic condition that develops following breast cancer treatment and is traditionally considered to result from impaired lymphatic drainage and fluid accumulation. Recent evidence suggests that autonomic nervous system dysfunction may also contribute to the pathophysiology of lymphedema.
The aim of this prospective observational study was to evaluate sympathetic skin response (SSR), autonomic nervous system functions, and their relationship with clinical response to complex decongestive therapy (CDT) in patients with postmastectomy upper extremity lymphedema.
Thirty female patients aged 18-65 years with unilateral upper extremity lymphedema after breast cancer treatment and thirty healthy female controls were included. All participants underwent electrophysiological autonomic nervous system evaluation using SSR and R-R interval variability measurements. In addition, autonomic symptoms were assessed using the Composite Autonomic Symptom Score-31 (COMPASS-31).
Patients in the lymphedema group received a standardized CDT program for 3 weeks, 5 days per week, totaling 15 sessions. Clinical response to treatment was evaluated using changes in lymphedema volume measurements obtained before and after treatment.
Secondary clinical assessments included quality of life evaluation with LYMQOL-Arm, upper extremity functional assessment with QuickDASH, pain severity assessment using the Numeric Rating Scale (NRS), and neuropathic pain evaluation using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 是
入选标准
- •Healthy Control Inclusion Criteria:
- •Female volunteers aged between 18 and 65 years
- •No history of breast cancer or lymphedema
- •No neurological, metabolic, or systemic disease affecting autonomic nervous system function
- •Healthy Control
排除标准
- •History of breast cancer or lymphedema
- •Polyneuropathy
- •Diabetes mellitus
- •Hypothyroidism
- •Neurological disease
- •Systemic diseases affecting autonomic nervous system function
- •Patient group;
- •Inclusion Criteria:
- •Inclusion Criteria:
- •Female patients aged between 18 and 65 years
- •Postmastectomy upper extremity lymphedema after breast cancer surgery
- •Completion of breast cancer treatment protocols
- •International Society of Lymphology (ISL) stage I-II lymphedema
- •Exclusion Criteria:
- •Metastatic breast cancer
- •Bilateral breast cancer history
- •Bilateral upper extremity lymphedema
- •Ongoing chemotherapy or radiotherapy
- •Infection or allergic skin lesions on the upper extremities
- •Medical conditions causing edema, including decompensated heart, lung, or renal failure
- •Peripheral nervous system disease or polyneuropathy
- •Chronic endocrine, metabolic, neurological, or systemic diseases affecting autonomic nervous system function, including diabetes mellitus, hypo/hyperthyroidism, uremia, heart failure, cardiac arrhythmia, and uncontrolled hypertension
- •Presence of a cardiac pacemaker
- •Inability to tolerate electrical stimulation
研究者
Sehri Baris
Resident Physician in Physical Medicine and Rehabilitation
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital