The Relationship Between Primary Lymphedema and Joint Hypermobility

NCT ID: NCT06399458

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 67 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2024-04-15

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 life.Primary lymphoedema (PLE) is thought to result from abnormal development and/or 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 III/type 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.

Conditions

Lymphedema of Upper Limb

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

1. group

Patients with lymphedema in the lower extremity

For hypermobility; Beighton score and Brighton revised 1998 Criteria

Intervention Type: DIAGNOSTIC_TEST

Beighton score and Brighton revised 1998 Criteria

2. group

Patients with lymphedema or no edema in the lower extremities

For hypermobility; Beighton score and Brighton revised 1998 Criteria

Intervention Type: DIAGNOSTIC_TEST

Beighton score and Brighton revised 1998 Criteria

Interventions

For hypermobility; Beighton score and Brighton revised 1998 Criteria

Beighton score and Brighton revised 1998 Criteria

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

Patients diagnosed with primary lymphedema between the ages of 18-65. Individuals between the ages of 18-65 without a diagnosis of lymphedema. Lymphedema stage 1,2,3 patients. Sufficient cognitive functions.

Exclusion Criteria

Being diagnosed with secondary lymphedema. Patients with lower extremity edema due to other reasons (such as cardiac, nephrogenic, myxedema), in this context, patients with cardiac failure, renal failure, thyroid hormone disorders Patients using edema-inducing drugs (corticosteroids, calcium channel blockers, gabapentin, pregabalin Patients diagnosed with rheumatological disease Patients with signs of infection in their legs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Feyza Akan Begoğlu

Role: PRINCIPAL_INVESTIGATOR

Fatih Sultan Mehmet Training and Research Hospital

Locations

Fatih Sultan Mehmet Research and Training Hospital

Istanbul, Ataşehir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

feyzabegoglu

Identifier Type: -

Identifier Source: org_study_id