Lymphedema of Upper Limb Clinical Trial
Official title:
Ultrasonographic Evaluation of the Effectiveness of Stellate Ganglion Block in Patients With Breast Cancer Related Lymphedema
Lymphedema is a condition characterized by generalized or regional accumulation of protein-rich interstitial fluid as a result of impaired lymphatic circulation due to congenital or acquired disorders. Lymphedema is diagnosed through evaluations of its clinical criteria. Lymphedema is mostly evaluated through arm circumference measurements, water displacement measurements, tonometry, bioimpedance analysis, ultrasonography (US), computed tomography, lymphoscintigraphy and magnetic resonance imaging (MRI). Targets in the treatment of lymphedema include controlling the symptoms and preventing complications. A multimodal technique called complete decongestive therapy (CDT) is considered the gold standard of the treatment of lymphedema. In the literature, there are also studies showing that stellate ganglion block in breast cancer-related lymphedema treatment improves lymphedema and symptoms. Cervical stellate ganglion block is an invasive method used for the diagnosis and treatment of sympathetic pain and symptoms of upper extremity. Although it can be performed with fluoroscopy, CT and MRI, there has been increasing interest in ultrasound-guided technique since it has been fast, easy and cost-effective for the last few years. However, there are limited studies to provide sufficient evidence for the use of stellate ganglion block as an alternative treatment for lymphedema and detailed studies are needed in this area. The aim of this study is ultrasonographic evaluation of the efficacy of stellate ganglion block in the treatment of patients with breast cancer related lymphedema that is resistant to conservative treatment methods .
Lymphedema is a condition characterized by generalized or regional accumulation of
protein-rich interstitial fluid as a result of impaired lymphatic circulation due to
congenital or acquired disorders. Lymphedema is diagnosed through evaluations of its clinical
criteria. In addition to swelling of the affected extremities, certain symptoms, such as
pain, fatigue, tightness, heaviness, tingling, weakness, and movement restriction, can also
be seen in cases of lymphedema. Arm circumference measurements and volumetric methods are the
most commonly used methods for calculating limb volume. In addition, soft tissue edema can be
quantitatively measured by ultrasonography (US), computed tomography, lymphoscintigraphy and
magnetic resonance imaging (MRI). Among these, US has been used more frequently in the
evaluation of lymphedema. Ultrasonographic evaluation of the skin and subcutaneous tissue
helps to determine the severity of lymphedema and the effectiveness of treatment. The
reliability and utility of ultrasound in subcutaneous echogenicity grade (SEG) and
subcutaneous echo-free space (SEFS) grade have been demonstrated in patients with breast
cancer-related lymphedema. Targets in the treatment of lymphedema include controlling the
symptoms and preventing complications. A multimodal technique called complete decongestive
therapy (CDT) is considered the gold standard of the treatment of lymphedema. In the
literature, there are also studies showing that stellate ganglion block in breast
cancer-related lymphedema treatment improves lymphedema and symptoms. Cervical stellate
ganglion block is an invasive method used for the diagnosis and treatment of sympathetic pain
and symptoms of upper extremity. Although it can be performed with fluoroscopy, CT and MRI,
there has been increasing interest in ultrasound-guided technique since it has been fast,
easy and cost-effective for the last few years. However, there are limited studies to provide
sufficient evidence for the use of stellate ganglion block as an alternative treatment for
lymphedema and detailed studies are needed in this area. The aim of this study is
ultrasonographic evaluation of the efficacy of stellate ganglion block in the treatment of
patients with breast cancer related lymphedema that is resistant to conservative treatment
methods.
Patients with breast cancer-related lymphedema will be evaluated for the study. For the
diagnosis of lymphedema, detailed physical examination and limb circumference measurements
will be performed. The patients with stage 2-3 lymphedema according to ISL staging, who had
passed at least 3 months after breast surgery and did not response to conservative treatment
methods will be included to the study. After obtaining written and oral informed consent of
patients, US- guided stellate ganglion block will be applied two times at two-week intervals.
Patients will be evaluated before injections (weeks 0 and 2) and 2 weeks after the last
injection (week 4) and at 3 months of treatment. Arm circumference will be measured from 5
different areas, shoulder range of motion (ROM) will be evaluated with a goniometer, pain,
and tightness and heaviness sensation will be assessed with visual analog scale. Quick-DASH
questionnaire and Lymphedema Life Impcat scale will be applied to the patients. SEG and SEFS
grade will be performed by evaluating subcutaneous tissue with USG.
After data collection, analysis will be performed with the appropriate statistical method.
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