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).
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Ankara
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Ankara, Ankara, Türkei (türkiye), 06800
- Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Lymphedema volume difference and sympathetic skin response (SSR) parameters
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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R-R interval variability (RRIV)
Zeitfenster: Baseline and after 3 weeks of complex decongestive therapy
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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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Nervensystems
- Postoperative Komplikationen
- Pathologische Prozesse
- Neubildungen nach Standort
- Neubildungen
- Hautkrankheiten
- Brusterkrankungen
- Lymphatische Erkrankungen
- Erkrankungen des autonomen Nervensystems
- Pathologische Zustände, Anzeichen und Symptome
- Haut- und Bindegewebserkrankungen
- Hämische und lymphatische Krankheiten
- Brustkrebs-Lymphödem
- Neoplasien der Brust
- Lymphödem
- Primäre Dysautonomien
Andere Studien-ID-Nummern
- BCRL-SSR-2026
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