LipedemaNCT04643392
Physiotherapy Applications in Upper Extremity Lipedema
An observational study of Lipedema, run by Yuksek Ihtisas University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- Complex decongestive physiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2019to 4 May 2020
- How long will I take part?
- 4 Weeks
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- being between the ages of 18-65,
- having a diagnosis of upper extremity lipedema
- being willing to participate in the study
Who cannot join
- accompanying diagnosis of lymphedema,
- deep vein thrombosis
- disease which causes edema in the upper extremities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Complex Decongestive Physiotherapy Applications on Upper Extremity Circumference and Volume in Patients With Lipedema
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.
Read the 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.
- Conditions
- Lipedema
- Being tested
- Complex decongestive physiotherapy
- Keywords
- Upper extremity lipedema, Lymphatic drainage
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex decongestive physiotherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Lipedema | Participants who were diagnosed with upper extremity lipedema by a lymphologist. Receives: Procedure: Complex decongestive physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb Circumference
For every patient, the circumference measurements of the upper limbs were measured with the Perometer.
Measured: Change from baseline circumference at 4 weeks
Limb Volume
For every patient, the volume measurements of the upper limbs were measured with the Perometer.
Measured: Change from baseline volume at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start2 Sep 2019
- Primary completion3 Feb 2020
- Study completion4 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LipedemaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melek Volkan Yazici, Yuksek Ihtisas University
- Investigators
- Melek Volkan-Yazici, PT. PhD, Principal investigator, Yuksek Ihtisas UniversityMurat Esmer, PT. MSc, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643392
- Sponsor's protocol ID
- YIU
- Status last verified
- Nov 2020
- First submitted
- 18 Nov 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33798399
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Complex Decongestive Physiotherapy Applications on Upper Extremity Circumference and Volume in Patients With Lipedema
- ClinicalTrials.gov ID
- NCT04643392
- Acronym / sponsor ID
- YIU
- Conditions
- Lipedema
- Keywords
- Upper extremity lipedema, Lymphatic drainage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Yuksek Ihtisas UniversityUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 25 Nov 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Lipedema | – | Procedure: Complex decongestive physiotherapyParticipants who were diagnosed with upper extremity lipedema by a lymphologist. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- being between the ages of 18-65,
- having a diagnosis of upper extremity lipedema
- being willing to participate in the study
Key exclusion criteria (3 listed)
- accompanying diagnosis of lymphedema,
- deep vein thrombosis
- disease which causes edema in the upper extremities
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 |
|---|---|---|
| Complex decongestive physiotherapyEach 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. | Procedure or surgery | Patients with Lipedema |
Primary outcome
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.
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.
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 25 Nov 2020.
- Derived from this study: PubMed 33798399Volkan-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.
- 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.
Melek Volkan-Yazici, PT. PhD principal investigator
Yuksek Ihtisas University
Murat Esmer, PT. MSc study director
Gazi University
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 Lipedema, run by Yuksek Ihtisas University 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 3 inclusion and 3 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 25 Nov 2020. 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?
Limb Circumference (time frame: Change from baseline circumference at 4 weeks). 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?
On the ClinicalTrials.gov record for NCT04643392, which also lists 1 linked publication.
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 25 Nov 2020.