Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
Ankara, 06800, Turkey (Türkiye)
NCT Number: NCT07585253
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).
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Notify Me18 year–65 year
Female
Observational
Ankara, 06800, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Healthy Control Inclusion Criteria:
Healthy Control Exclusion Criteria:
Patient group;
Inclusion criteria
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: Baseline and after 3 weeks of complex decongestive therapy
Autonomic symptoms were evaluated using the Composite Autonomic Symptom Score-31 questionnaire.
Time frame: Baseline and after 3 weeks of complex decongestive therapy
Quality of life related to upper extremity lymphedema was evaluated using the LYMQOL-Arm questionnaire.
Time frame: Baseline and after 3 weeks of complex decongestive therapy
Upper extremity functional status was assessed using the QuickDASH questionnaire.
Time frame: Baseline and after 3 weeks of complex decongestive therapy
Pain severity was evaluated using the Numeric Rating Scale.
Time frame: Baseline and after 3 weeks of complex decongestive therapy
Neuropathic pain symptoms were evaluated using the LANSS questionnaire.
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Other
Acronym: BCRL-SSR
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