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Evaluation of Sympathetic Skin Response and Its Relationship With Clinical Response to Complex Decongestive Therapy in Patients With Postmastectomy Lymphedema (BCRL-SSR)

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).

연구 개요

상세 설명

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).

The study aimed to determine whether autonomic dysfunction is present in breast cancer-related lymphedema and whether baseline SSR parameters are associated with clinical response to CDT.

연구 유형

관찰

등록 (실제)

60

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Ankara
      • Ankara, Ankara, 터키 (Türkiye), 06800
        • Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

샘플링 방법

비확률 샘플

연구 인구

The study population consisted of female patients aged 18-65 years with unilateral postmastectomy upper extremity lymphedema following breast cancer treatment and age-matched healthy female volunteers. Patients had completed breast cancer treatment protocols and had ISL stage I-II lymphedema. Healthy controls had no history of breast cancer, lymphedema, neurological disease, metabolic disorder, or systemic condition affecting autonomic nervous system function.

설명

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 Exclusion Criteria:

  • 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Lymphedema volume difference and sympathetic skin response (SSR) parameters
기간: Baseline and after 3 weeks of complex decongestive therapy
Upper extremity lymphedema volume difference and sympathetic skin response (SSR) parameters were evaluated before and after complex decongestive therapy. Limb volume was calculated using circumferential measurements obtained at 4-cm intervals with the truncated cone formula. SSR recordings were obtained using surface electrodes and median nerve stimulation. Peak-to-peak amplitude and latency values were analyzed.
Baseline and after 3 weeks of complex decongestive therapy

2차 결과 측정

결과 측정
측정값 설명
기간
R-R interval variability (RRIV)
기간: Baseline and after 3 weeks of complex decongestive therapy
Cardiac autonomic function was evaluated using R-R interval variability measurements during resting and deep breathing conditions.
Baseline and after 3 weeks of complex decongestive therapy
COMPASS-31 score
기간: Baseline and after 3 weeks of complex decongestive therapy
Autonomic symptoms were evaluated using the Composite Autonomic Symptom Score-31 questionnaire.
Baseline and after 3 weeks of complex decongestive therapy
LYMQOL-Arm score
기간: Baseline and after 3 weeks of complex decongestive therapy
Quality of life related to upper extremity lymphedema was evaluated using the LYMQOL-Arm questionnaire.
Baseline and after 3 weeks of complex decongestive therapy
QuickDASH score
기간: Baseline and after 3 weeks of complex decongestive therapy
Upper extremity functional status was assessed using the QuickDASH questionnaire.
Baseline and after 3 weeks of complex decongestive therapy
Numeric Rating Scale (NRS)
기간: Baseline and after 3 weeks of complex decongestive therapy
Pain severity was evaluated using the Numeric Rating Scale.
Baseline and after 3 weeks of complex decongestive therapy
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
기간: Baseline and after 3 weeks of complex decongestive therapy
Neuropathic pain symptoms were evaluated using the LANSS questionnaire.
Baseline and after 3 weeks of complex decongestive therapy

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 1월 25일

기본 완료 (실제)

2026년 2월 12일

연구 완료 (실제)

2026년 2월 12일

연구 등록 날짜

최초 제출

2026년 5월 7일

QC 기준을 충족하는 최초 제출

2026년 5월 7일

처음 게시됨 (실제)

2026년 5월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 20일

마지막으로 확인됨

2026년 5월 1일

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