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).
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Ankara
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Ankara, Ankara, Turcja (Türkiye), 06800
- Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Lymphedema volume difference and sympathetic skin response (SSR) parameters
Ramy czasowe: Baseline and after 3 weeks of complex decongestive therapy
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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.
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Baseline and after 3 weeks of complex decongestive therapy
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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R-R interval variability (RRIV)
Ramy czasowe: 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.
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Baseline and after 3 weeks of complex decongestive therapy
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COMPASS-31 score
Ramy czasowe: Baseline and after 3 weeks of complex decongestive therapy
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Autonomic symptoms were evaluated using the Composite Autonomic Symptom Score-31 questionnaire.
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Baseline and after 3 weeks of complex decongestive therapy
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LYMQOL-Arm score
Ramy czasowe: Baseline and after 3 weeks of complex decongestive therapy
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Quality of life related to upper extremity lymphedema was evaluated using the LYMQOL-Arm questionnaire.
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Baseline and after 3 weeks of complex decongestive therapy
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QuickDASH score
Ramy czasowe: Baseline and after 3 weeks of complex decongestive therapy
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Upper extremity functional status was assessed using the QuickDASH questionnaire.
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Baseline and after 3 weeks of complex decongestive therapy
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Numeric Rating Scale (NRS)
Ramy czasowe: Baseline and after 3 weeks of complex decongestive therapy
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Pain severity was evaluated using the Numeric Rating Scale.
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Baseline and after 3 weeks of complex decongestive therapy
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Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
Ramy czasowe: Baseline and after 3 weeks of complex decongestive therapy
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Neuropathic pain symptoms were evaluated using the LANSS questionnaire.
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Baseline and after 3 weeks of complex decongestive therapy
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Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Choroby Układu Nerwowego
- Powikłania pooperacyjne
- Procesy patologiczne
- Nowotwory według lokalizacji
- Nowotwory
- Choroby skórne
- Choroby piersi
- Choroby limfatyczne
- Choroby autonomicznego układu nerwowego
- Stany patologiczne, oznaki i objawy
- Choroby skóry i tkanki łącznej
- Choroby hemowe i limfatyczne
- Obrzęk limfatyczny raka piersi
- Nowotwory piersi
- Obrzęk limfatyczny
- Pierwotne dysautonomie
Inne numery identyfikacyjne badania
- BCRL-SSR-2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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