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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
a mixture of 4 mL 0.5% bupivacaine (marcaine) and 1 mL 40 mg triamcinolone (kenacort-a)
Canan Şanal-Toprak
Istanbul, Turkey (Türkiye)
Arm circumference difference
Circumference differences between the affected and unaffected arms will be measured with a nonelastic tape measure at five levels; metacarpophalangeal joints, wrist, 15 cm distally from the medial epicondyle, medial epicondyle and 15 cm proximally from the medial epicondyle upper extremities.
Time frame: before treatment (T0)
Arm circumference difference
Circumference differences between the affected and unaffected arms will be measured with a nonelastic tape measure at five levels; metacarpophalangeal joints, wrist, 15 cm distally from the medial epicondyle, medial epicondyle and 15 cm proximally from the medial epicondyle upper extremities.
Time frame: 2nd week of treatment (T1)
Arm circumference difference
Circumference differences between the affected and unaffected arms will be measured with a nonelastic tape measure at five levels; metacarpophalangeal joints, wrist, 15 cm distally from the medial epicondyle, medial epicondyle and 15 cm proximally from the medial epicondyle upper extremities.
Time frame: 4th week of treatment (T2)
Arm circumference difference
Circumference differences between the affected and unaffected arms will be measured with a nonelastic tape measure at five levels; metacarpophalangeal joints, wrist, 15 cm distally from the medial epicondyle, medial epicondyle and 15 cm proximally from the medial epicondyle upper extremities.
Time frame: 3rd month of treatment (T3)
Subcutaneous echogenicity grade (SEG)
SEG will be performed by evaluating subcutaneous tissue with USG. Grade 0: No or little increase in echogenicity. Grade 1: Grade 1: Diffuse and monotonous increases in echogenicity Grade 2: Diffuse increases in echogenicity
Time frame: before treatment (T0)
Subcutaneous echogenicity grade (SEG)
SEG will be performed by evaluating subcutaneous tissue with USG. Grade 0: No or little increase in echogenicity. Grade 1: Grade 1: Diffuse and monotonous increases in echogenicity Grade 2: Diffuse increases in echogenicity
Time frame: 2nd week of treatment (T1)
Subcutaneous echogenicity grade (SEG)
SEG will be performed by evaluating subcutaneous tissue with USG. Grade 0: No or little increase in echogenicity. Grade 1: Grade 1: Diffuse and monotonous increases in echogenicity Grade 2: Diffuse increases in echogenicity
Time frame: 4th week of treatment (T2)
Subcutaneous echogenicity grade (SEG)
SEG will be performed by evaluating subcutaneous tissue with USG. Grade 0: No or little increase in echogenicity. Grade 1: Grade 1: Diffuse and monotonous increases in echogenicity Grade 2: Diffuse increases in echogenicity
Time frame: 3rd month of treatment (T3)
Subcutaneous echo-free space (SEFS) grade
SEFS grade will be performed by evaluating subcutaneous tissue with USG. Grade 0: No SEFS. Grade 1: Horizontally oriented (\<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (≥45 degrees to the skin) SEFS bridging the horizontally oriented SEFSs.
Time frame: before treatment (T0)
Subcutaneous echo-free space (SEFS) grade
SEFS grade will be performed by evaluating subcutaneous tissue with USG. Grade 0: No SEFS. Grade 1: Horizontally oriented (\<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (≥45 degrees to the skin) SEFS bridging the horizontally oriented SEFSs.
Time frame: 2nd week of treatment (T1)
Subcutaneous echo-free space (SEFS) grade
SEFS grade will be performed by evaluating subcutaneous tissue with USG. Grade 0: No SEFS. Grade 1: Horizontally oriented (\<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (≥45 degrees to the skin) SEFS bridging the horizontally oriented SEFSs.
Time frame: 4th week of treatment (T2)
Subcutaneous echo-free space (SEFS) grade
SEFS grade will be performed by evaluating subcutaneous tissue with USG. Grade 0: No SEFS. Grade 1: Horizontally oriented (\<45 degrees to the skin) SEFS only. Grade 2: Presence of vertically oriented (≥45 degrees to the skin) SEFS bridging the horizontally oriented SEFSs.
Time frame: 3rd month of treatment (T3)
shoulder range of motion (ROM) will be evaluated with a goniometer
Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, adduction, internal and external rotation.
Time frame: before treatment (T0)
shoulder range of motion (ROM) will be evaluated with a goniometer
Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, adduction, internal and external rotation.
Time frame: 2nd week of treatment (T1)
shoulder range of motion (ROM) will be evaluated with a goniometer
Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, adduction, internal and external rotation.
Time frame: 4th week of treatment (T2)
shoulder range of motion (ROM) will be evaluated with a goniometer
Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, adduction, internal and external rotation.
Time frame: 3rd month of treatment (T3)
Pain, tightness and heaviness sensation
Shoulder pain and sensations of tightness and heaviness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
Time frame: before treatment (T0)
Pain, tightness and heaviness sensation
Shoulder pain and sensations of tightness and heaviness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
Time frame: 2nd week of treatment (T1)
Pain, tightness and heaviness sensation
Shoulder pain and sensations of tightness and heaviness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
Time frame: 4th week of treatment (T2)
Pain, tightness and heaviness sensation
Shoulder pain and sensations of tightness and heaviness will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)
Time frame: 3rd month of treatment (T3)
Activity and participation - Quick-DASH
Quick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. The questionnaire assesses the difficulty of the daily life activities of the patients with 11 questions. Each answer is scored from 1 to 5 with a Likert scale. There is also two optional 4-item additional modules for whose jobs require a lot of upper limb performance and for sports people and musicians. The validity and reliability of the questionnaire in Turkish were conducted by Düger et al.
Time frame: before treatment (T0)
Activity and participation - Quick-DASH
Quick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. The questionnaire assesses the difficulty of the daily life activities of the patients with 11 questions. Each answer is scored from 1 to 5 with a Likert scale. There is also two optional 4-item additional modules for whose jobs require a lot of upper limb performance and for sports people and musicians. The validity and reliability of the questionnaire in Turkish were conducted by Düger et al.
Time frame: 2nd week of treatment (T1)
Activity and participation - Quick-DASH
Quick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. The questionnaire assesses the difficulty of the daily life activities of the patients with 11 questions. Each answer is scored from 1 to 5 with a Likert scale. There is also two optional 4-item additional modules for whose jobs require a lot of upper limb performance and for sports people and musicians. The validity and reliability of the questionnaire in Turkish were conducted by Düger et al.
Time frame: 4th week of treatment (T2)
Activity and participation - Quick-DASH
Quick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. The questionnaire assesses the difficulty of the daily life activities of the patients with 11 questions. Each answer is scored from 1 to 5 with a Likert scale. There is also two optional 4-item additional modules for whose jobs require a lot of upper limb performance and for sports people and musicians. The validity and reliability of the questionnaire in Turkish were conducted by Düger et al.
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Time frame: 3rd month of treatment (T3)
Quality of life - Lymphedema Life Impact Scale
Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 function subgroups. Each question is scored between 1 and 5, and high scores indicate increased severity. The validity and reliability of the Turkish version was made by Değirmenci et al.
Time frame: before treatment (T0)
Quality of life - Lymphedema Life Impact Scale
Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 function subgroups. Each question is scored between 1 and 5, and high scores indicate increased severity. The validity and reliability of the Turkish version was made by Değirmenci et al.
Time frame: 2nd week of treatment (T1)
Quality of life - Lymphedema Life Impact Scale
Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 function subgroups. Each question is scored between 1 and 5, and high scores indicate increased severity. The validity and reliability of the Turkish version was made by Değirmenci et al.
Time frame: 4th week of treatment (T2)
Quality of life - Lymphedema Life Impact Scale
Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 function subgroups. Each question is scored between 1 and 5, and high scores indicate increased severity. The validity and reliability of the Turkish version was made by Değirmenci et al.
Time frame: 3rd month of treatment (T3)