Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399458
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2024-05-01
Brief Title:
The Relationship Between Primary Lymphedema and Joint Hypermobility
Sponsor:
Fatih Sultan Mehmet Training and Research Hospital
Organization:
Fatih Sultan Mehmet Training and Research Hospital
Study Overview
Official Title:
The Relationship Between Primary Lymphedema and Joint Hypermobility
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lymphoedema is the swelling of one or several parts of the body owing to lymph accumulation in the extracellular space It is often chronic worsens if untreated predisposes to infections and causes an important reduction in quality of lifePrimary lymphoedema PLE is thought to result from abnormal development andor functioning of the lymphatic system can present in isolation or as part of a syndrome and can be present at birth or develop later in life
Joint hypermobility JH is a clinical condition characterized an excess range of motion in a joint beyond the physiological range of motion
It is termed generalized joint hypermobilty GJH when the condition is asymptomatic when it is associated with symptoms such as arthralgia soft tissue damage and joint instability it is referred to as benign joint hypermobility syndrome BJHS An increase in the proportion of collagen or collagen subtypes such as type IIItype I has been detected in JH This abnormal collagen structure causes joint laxity and fragility of the connective tissue increases
The lymphatic system begins to develop at the end of the fifth gestational week Lymphatic vessels and lymph nodes develop from the mesoderm Mesoderm differentiates to form many tissues and structures including connective tissue muscle bone urogenital and circulatory systems The relationships between systems developing from the same mesoderm-derived structures such as carpal tunnel hypermobility lumbar disc herniation hypermobility shoulder impigment and adhesive capsulitis hypermobility and joint hypermobility were examined There are studies showing that hypermobility may pose a risk for venous insufficiency In addition one of the criteria for benign joint hypermobility syndrome is the presence of varicose veins It has been revealed that the lymphatic system develops embryonicly from the cardinal vein intersomatic vein and lymphangioblasts Therefore the lymphatic system can be considered as a branch of the developmental venous system with endothelial vascular walls We aimed to investigate the relationship between primary lymphedema and joint hypermobility as it has not been investigated before in the literature and based on this developmental similarity
Joint hypermobility JH is a clinical condition characterized an excess range of motion in a joint beyond the physiological range of motion
It is termed generalized joint hypermobilty GJH when the condition is asymptomatic when it is associated with symptoms such as arthralgia soft tissue damage and joint instability it is referred to as benign joint hypermobility syndrome BJHS An increase in the proportion of collagen or collagen subtypes such as type IIItype I has been detected in JH This abnormal collagen structure causes joint laxity and fragility of the connective tissue increases
The lymphatic system begins to develop at the end of the fifth gestational week Lymphatic vessels and lymph nodes develop from the mesoderm Mesoderm differentiates to form many tissues and structures including connective tissue muscle bone urogenital and circulatory systems The relationships between systems developing from the same mesoderm-derived structures such as carpal tunnel hypermobility lumbar disc herniation hypermobility shoulder impigment and adhesive capsulitis hypermobility and joint hypermobility were examined There are studies showing that hypermobility may pose a risk for venous insufficiency In addition one of the criteria for benign joint hypermobility syndrome is the presence of varicose veins It has been revealed that the lymphatic system develops embryonicly from the cardinal vein intersomatic vein and lymphangioblasts Therefore the lymphatic system can be considered as a branch of the developmental venous system with endothelial vascular walls We aimed to investigate the relationship between primary lymphedema and joint hypermobility as it has not been investigated before in the literature and based on this developmental similarity
Detailed Description:
The number of samples for our study was determined as minimum n 29 people for each group as a result of Power analysis using the GPower program The number of volunteers we will include in our study is 58 including the primary lymphedema group and the control group with similar characteristics and no lymphedema disease Patients who have previously come to the lymphedema outpatient clinic due to swelling in their legs and who have been diagnosed with primary lymphedema as a result of the examinations and tests will be included patients with swelling in their lower extremities regardless of whether there is an initiating factor stemmer test gode- doppler USG normal etiology-oriented abdominal inguinal USG patients whose results were normal but whose lymphoscintigraphy showed findings of lymphatic insufficiency Patients will be called and their joint range of motion will be examined for the Beighton score and the Brighton criteria will be questioned Male and female patients between the ages of 18-65 with primary lymphedema in their lower extremities and healthy volunteers in the same age range who do not have complaints such as edema or lymphedema in their lower extremities will be included in our study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None