The Relationship Between Primary Lymphedema and Joint Hypermobility

Lymphedema of Upper Limb Clinical Trial

Official title:

The Relationship Between Primary Lymphedema and Joint Hypermobility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06399458
• Other study ID #: feyzabegoglu
• Status: Completed
• Start date: March 15, 2024
• Est. completion date: April 15, 2024

Study information

• Verified date: May 2024
• Source: Fatih Sultan Mehmet Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Joint Instability
• Lymphedema
• Lymphedema of Upper Limb

Intervention

Diagnostic Test:
• For hypermobility; Beighton score and Brighton revised 1998 Criteria
Beighton score and Brighton revised 1998 Criteria

Locations

Country	Name	City	State
Turkey	Fatih Sultan Mehmet Research and Training Hospital	Istanbul	Atasehir

Sponsors (1)

Lead Sponsor	Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beighton Hypermobility Score	The following examinations are performed for the Beighton hypermobility score:1. Ability to touch palms flat to floor with knees straight (one point) 2. Elbow extension >10° (one point for each side) 3. Knee extension >10° (one point for each side) 4. Ability to touch thumb to forearm (one point for each side) 5. Fifth finger metocarpalphalageal joint extension >90° (one point for each side) Scores of 4 or above indicate Generalised Joint Hypermobility.	1 day
Primary	Revised Brighton Criteria	The Brighton Criteria is used in adults to diagnose Joint Hypermobility Syndrome. To make the diagnosis you need one of: two major criteria; one major and two minor criteria; four minor criteria; two minor criteria and one affected first degree relative. The presence of an underlying syndrome excludes the diagnosis.; Major Criteria: Beighton Score >3, Arthralgia > 3 months in four or more joints.; Minor Criteria: Beighton Score 1-3, Arthralgia > 3 months in one joint, backpain, or spondylosis / spondylolysis / ,spondylolisthesis.; Dislocation or subluxation in more than one joint, or in one joint repeatedly. Three or more soft tissue lesions (e.g epicondylitis, tenosynovitis, bursitis). Marfanoid habitus. Skin striae. Ocular signs (e.g drooping eyelids, myopia, antimongoloid slant). Varicose veins, hernia, uterine or rectal prolapse. Mitral valve prolapse.	1 day