Lymphedema of Upper LimbNCT06399458
The Relationship Between Primary Lymphedema and Joint Hypermobility
An observational study of Lymphedema of Upper Limb, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphedema of Upper Limb
- What is being tested?
- For hypermobility; Beighton score and Brighton revised 1998 Criteria
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 15 Apr 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Our study included male and female patients between the ages of 18-65 with primary lymphedema in the lower extremities and healthy volunteers in the same age range who did not have complaints such as edema or lymphedema in the lower extremities.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Research and Training Hospital
Istanbul, Ataşehir, 34752
About this study
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 .
Read more
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.
Read the 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
- Being tested
- For hypermobility; Beighton score and Brighton revised 1998 Criteria
- Keywords
- primary lymphedema, hyper mobility, Beighton score
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
For hypermobility; Beighton score and Brighton revised 1998 CriteriaDiagnostic test
Beighton score and Brighton revised 1998 Criteria
| Study group | Role | What they receive |
|---|---|---|
| 1. group | Patients with lymphedema in the lower extremity Receives: Diagnostic Test: For hypermobility; Beighton score and Brighton revised 1998 Criteria | |
| 2. group | Patients with lymphedema or no edema in the lower extremities Receives: Diagnostic Test: For hypermobility; Beighton score and Brighton revised 1998 Criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start15 Mar 2024
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema of Upper LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 67 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feyza Akan Begoğlu, Principal investigator, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399458
- Sponsor's protocol ID
- feyzabegoglu
- Status last verified
- May 2024
- First submitted
- 1 May 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Primary Lymphedema and Joint Hypermobility
- ClinicalTrials.gov ID
- NCT06399458
- Acronym / sponsor ID
- feyzabegoglu
- Conditions
- Lymphedema of Upper Limb
- Keywords
- primary lymphedema, hyper mobility, Beighton score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. group | – | Diagnostic Test: For hypermobility; Beighton score and Brighton revised 1998 CriteriaPatients with lymphedema in the lower extremity |
| 2. group | – | Diagnostic Test: For hypermobility; Beighton score and Brighton revised 1998 CriteriaPatients with lymphedema or no edema in the lower extremities |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Our study included male and female patients between the ages of 18-65 with primary lymphedema in the lower extremities and healthy volunteers in the same age range who did not have complaints such as edema or lymphedema in the lower extremities.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| For hypermobility; Beighton score and Brighton revised 1998 CriteriaBeighton score and Brighton revised 1998 Criteria | Diagnostic test | 1. group, 2. group |
Primary outcome
Beighton Hypermobility Score
Time frame: 1 day
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.
Revised Brighton Criteria
Time frame: 1 day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feyza Akan Begoğlu principal investigator
Fatih Sultan Mehmet Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema of Upper Limb, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beighton Hypermobility Score (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.