Effectiveness of Stellate Ganglion Block in Breast Cancer Related Lymphedema
Primary Purpose
Lymphedema of Upper Limb, Breast Cancer Related Lymphedema
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
bupivacaine and triamcinolone
Sponsored by
About this trial
This is an interventional treatment trial for Lymphedema of Upper Limb focused on measuring lymphedema, breast cancer, stellate ganglion, treatment, ultrasound
Eligibility Criteria
Inclusion Criteria:
- circumference difference of 2 cm or more between the affected and unaffected arm
- stage 2-3 lymphedema according to ISL staging
- aged between 18-70 years
- at least 3 months of follow-up breast surgery
- no response to the complete decongestive therapy enough
Exclusion Criteria:
- signs of cellulitis, lymphangitis, fungal infection,
- metastases to the lymph nodes
- uncontrolled psychiatric and systemic diseases
- contraindications for stellate ganglion block
Sites / Locations
- Canan Şanal-Toprak
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
stellate ganglion block in breast cancer related lymphedema
Arm Description
US-guided stellat ganglion block will be applied to the patients with breast cancer related lymphedema twice at two-week intervals.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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)
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)
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)
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)
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04165512
Brief Title
Effectiveness of Stellate Ganglion Block in Breast Cancer Related Lymphedema
Official Title
Ultrasonographic Evaluation of the Effectiveness of Stellate Ganglion Block in Patients With Breast Cancer Related Lymphedema
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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 .
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema of Upper Limb, Breast Cancer Related Lymphedema
Keywords
lymphedema, breast cancer, stellate ganglion, treatment, ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
stellate ganglion block in breast cancer related lymphedema
Arm Type
Experimental
Arm Description
US-guided stellat ganglion block will be applied to the patients with breast cancer related lymphedema twice at two-week intervals.
Intervention Type
Combination Product
Intervention Name(s)
bupivacaine and triamcinolone
Other Intervention Name(s)
Marcaine, Kenacort-a
Intervention Description
a mixture of 4 mL 0.5% bupivacaine (marcaine) and 1 mL 40 mg triamcinolone (kenacort-a)
Primary Outcome Measure Information:
Title
Arm circumference difference
Description
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)
Title
Arm circumference difference
Description
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)
Title
Arm circumference difference
Description
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)
Title
Arm circumference difference
Description
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)
Title
Subcutaneous echogenicity grade (SEG)
Description
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)
Title
Subcutaneous echogenicity grade (SEG)
Description
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)
Title
Subcutaneous echogenicity grade (SEG)
Description
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)
Title
Subcutaneous echogenicity grade (SEG)
Description
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)
Title
Subcutaneous echo-free space (SEFS) grade
Description
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)
Title
Subcutaneous echo-free space (SEFS) grade
Description
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)
Title
Subcutaneous echo-free space (SEFS) grade
Description
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)
Title
Subcutaneous echo-free space (SEFS) grade
Description
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)
Title
shoulder range of motion (ROM) will be evaluated with a goniometer
Description
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)
Title
shoulder range of motion (ROM) will be evaluated with a goniometer
Description
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)
Title
shoulder range of motion (ROM) will be evaluated with a goniometer
Description
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)
Title
shoulder range of motion (ROM) will be evaluated with a goniometer
Description
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)
Title
Pain, tightness and heaviness sensation
Description
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)
Title
Pain, tightness and heaviness sensation
Description
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)
Title
Pain, tightness and heaviness sensation
Description
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)
Title
Pain, tightness and heaviness sensation
Description
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)
Secondary Outcome Measure Information:
Title
Activity and participation - Quick-DASH
Description
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)
Title
Activity and participation - Quick-DASH
Description
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)
Title
Activity and participation - Quick-DASH
Description
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)
Title
Activity and participation - Quick-DASH
Description
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
3rd month of treatment (T3)
Title
Quality of life - Lymphedema Life Impact Scale
Description
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)
Title
Quality of life - Lymphedema Life Impact Scale
Description
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)
Title
Quality of life - Lymphedema Life Impact Scale
Description
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)
Title
Quality of life - Lymphedema Life Impact Scale
Description
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)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
circumference difference of 2 cm or more between the affected and unaffected arm
stage 2-3 lymphedema according to ISL staging
aged between 18-70 years
at least 3 months of follow-up breast surgery
no response to the complete decongestive therapy enough
Exclusion Criteria:
signs of cellulitis, lymphangitis, fungal infection,
metastases to the lymph nodes
uncontrolled psychiatric and systemic diseases
contraindications for stellate ganglion block
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülseren Akyüz, Prof
Organizational Affiliation
Marmara University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Canan Şanal-Toprak, Asst. Prof
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Canan Şanal-Toprak
City
İstanbul
ZIP/Postal Code
34899
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28018504
Citation
Suehiro K, Morikage N, Yamashita O, Harada T, Samura M, Takeuchi Y, Mizoguchi T, Nakamura K, Hamano K. Skin and Subcutaneous Tissue Ultrasonography Features in Breast Cancer-Related Lymphedema. Ann Vasc Dis. 2016;9(4):312-316. doi: 10.3400/avd.oa.16-00086. Epub 2016 Nov 25.
Results Reference
background
PubMed Identifier
25589949
Citation
Kim J, Park HS, Cho SY, Baik HJ, Kim JH. The effect of stellate ganglion block on intractable lymphedema after breast cancer surgery. Korean J Pain. 2015 Jan;28(1):61-3. doi: 10.3344/kjp.2015.28.1.61. Epub 2015 Jan 2.
Results Reference
background
PubMed Identifier
25577504
Citation
Kim JG, Bae SO, Seo KS. A comparison of the effectiveness of complex decongestive physiotherapy and stellate ganglion block with triamcinolone administration in breast cancer-related lymphedema patients. Support Care Cancer. 2015 Aug;23(8):2305-10. doi: 10.1007/s00520-014-2593-5. Epub 2015 Jan 11.
Results Reference
background
PubMed Identifier
25675063
Citation
Park JH, Min YS, Chun SM, Seo KS. Effects of stellate ganglion block on breast cancer-related lymphedema: comparison of various injectates. Pain Physician. 2015 Jan-Feb;18(1):93-9.
Results Reference
background
PubMed Identifier
31151333
Citation
Park MW, Lee SU, Kwon S, Seo KS. Comparison Between the Effectiveness of Complex Decongestive Therapy and Stellate Ganglion Block in Patients with Breast Cancer-Related Lymphedema: A Randomized Controlled Study. Pain Physician. 2019 May;22(3):255-263.
Results Reference
background
Learn more about this trial
Effectiveness of Stellate Ganglion Block in Breast Cancer Related Lymphedema
We'll reach out to this number within 24 hrs