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Physiotherapy Applications in Upper Extremity Lipedema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04643392
Recruitment Status : Completed
First Posted : November 25, 2020
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
Melek Volkan Yazici, Yuksek Ihtisas University

Study Description
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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.

Condition or disease Intervention/treatment
Lipedema Procedure: Complex decongestive physiotherapy

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.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: The Effects of Complex Decongestive Physiotherapy Applications on Upper Extremity Circumference and Volume in Patients With Lipedema
Actual Study Start Date : September 2, 2019
Actual Primary Completion Date : February 3, 2020
Actual Study Completion Date : May 4, 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with Lipedema
Participants who were diagnosed with upper extremity lipedema by a lymphologist.
 Procedure: Complex decongestive physiotherapy
Each patient received a treatment protocol of Complex decongestive physiotherapy for 5 days a week until they were discharged from the clinic. All patients fully completed all components of the treatment routine daily. The treatment was performed by a physiotherapist who was certified with Manual Lymph Drainage Combined Decongestive Physiotherapy. After the daily treatment protocol was completed, patients wore standard or individually sized compression grade II or III medical compression stockings for the rest of the day.


Outcome Measures
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Primary Outcome Measures :
  1. Limb Circumference [ Time Frame: Change from baseline circumference at 4 weeks ]
    For every patient, the circumference measurements of the upper limbs were measured with the Perometer.

  2. Limb Volume [ Time Frame: Change from baseline volume at 4 weeks ]
    For every patient, the volume measurements of the upper limbs were measured with the Perometer.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04643392


Locations
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Turkey
Yuksek Ihtisas University
Ankara, Turkey, 06560
Sponsors and Collaborators
Yuksek Ihtisas University
Investigators
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Principal Investigator: Melek Volkan-Yazici, PT. PhD Yuksek Ihtisas University
Study Director: Murat Esmer, PT. MSc Gazi University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Melek Volkan Yazici, Principal Investigator, Yuksek Ihtisas University
ClinicalTrials.gov Identifier: NCT04643392    
Other Study ID Numbers: YIU
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Melek Volkan Yazici, Yuksek Ihtisas University:
Upper extremity lipedema
Lymphatic drainage
Additional relevant MeSH terms:
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Lipedema
Connective Tissue Diseases