Clinical trial NCT04643392: Physiotherapy Applications in Upper Extremity Lipedema
Official title: The Effects of Complex Decongestive Physiotherapy Applications on Upper Extremity Circumference and Volume in Patients With Lipedema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lipedema
Keywords: Upper extremity lipedema
Lymphatic drainage
Lead sponsor: Yuksek Ihtisas University
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between the age of 18-65 who have lipedema affecting the upper extremities and no accompanying diagnosis of lymphedema, deep vein thrombosis or any disease which causes edema in the upper extremities.

Brief summary: Lipedema which causes excessive accumulation of fat in the subcutaneous tissue, is a rare, progressive disease. This disease generally affects women, following puberty or early adulthood and usually results in the slow increase of the circumference of the legs and/or arms, bilaterally. In a typical presentation of lipedema, the enlargement of the lower extremities is disproportionately greater than that of the trunk and upper extremities When first described in 1940, lipedema was thought to exclusively affect the lower extremities. However, as the disease has been recognized over the years, lipedema has been reported to affect the upper extremities. Upper extremity lipedema, with no involvement of the lower extremities is an extremely rare incident.

Detailed description: Due to the hypertrophy in adipose tissue, the link between lymphatic dysfunction and the progression to lipo-lymphedema, lipedema is conservatively treated with physiotherapy, manual lymph drainage and compression, also known as complex decongestive physiotherapy. Furthermore, the consensus of the International Society of Lymphology has stated that intermittent pneumatic compression is an optional treatment which may be applied as an adjuvant therapy to complex decongestive physiotherapy. All participants included in the study were included in a treatment protocol consisting of complex decongestive physiotherapy and intermittent pneumatic compression. The Perometer was used in the measurement of upper extremity volume and circumference before and after treatment.

Eligibility criteria: Inclusion Criteria:

* being between the ages of 18-65,
* having a diagnosis of upper extremity lipedema
* being willing to participate in the study

Exclusion Criteria:

* accompanying diagnosis of lymphedema,
* deep vein thrombosis
* disease which causes edema in the upper extremities

Primary outcomes:
measure: Limb Circumference
timeFrame: Change from baseline circumference at 4 weeks
measure: Limb Volume
timeFrame: Change from baseline volume at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Yuksek Ihtisas University
Study officials:
affiliation: Yuksek Ihtisas University
name: Melek Volkan-Yazici, PT. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Murat Esmer, PT. MSc
role: STUDY_DIRECTOR
References:
citation: Volkan-Yazici M, Esmer M. Reducing Circumference and Volume in Upper Extremity Lipedema: The Role of Complex Decongestive Physiotherapy. Lymphat Res Biol. 2022 Feb;20(1):71-75. doi: 10.1089/lrb.2020.0128. Epub 2021 Apr 5.