FibromyalgiaNCT06749379
LIPEDEMA AWARENESS IN FIBROMYALGIA
An observational study of Fibromyalgia and Lipedema, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial summary
Lipedema is a chronic debilitating condition that impacts the subcutaneous adipose tissue of the extremities. It is a chronic condition but should not be regarded as always progressing.The clinical course varies individually and is unpredictable. It may considerably diminish the patient's quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Lipedema
- What is being tested?
- Presence and stages of lipedema were diagnosed with examination.
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Mar 2023
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study included 100 female patients over the age of 18 who met the fibromyalgia diagnostic criteria according to the American College of Rheumatology (ACR) 2016 Fibromyalgia Diagnostic Criteria.
Who may be able to join
- female patients
- over the age of 18
- who met the fibromyalgia diagnostic criteria according to the American College of Rheumatology (ACR) 2016 Fibromyalgia Diagnostic Criteria
Who cannot join
- renal or cardiac insufficiency,
- the use of any drug that could influence body fluid and electrolyte balance,
- the presence of a major somatic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Lipedema is a chronic debilitating condition that impacts the subcutaneous adipose tissue of the extremities. It is a chronic condition but should not be regarded as always progressing.The clinical course varies individually and is unpredictable. It may considerably diminish the patient's quality of life. Fibromyalgia, similar to lipedema, is a debilitating chronic pain disease of unclear origin that primarily affects women. It is a complex syndrome marked by widespread pain and tenderness. Fibromyalgia and lipedema are both marked by pain related to soft tissue. Both disorders are not amenable to curative treatment, resulting in a significant burden on individual and public health. No definitive indicators, including abnormal laboratory or imaging results, can be discerned to differentiate one disorder from another.
With this perspective, the aim of our study was to evaluate the presence of lipedema and lipedema-related factors in fibromyalgia patients.
- Conditions
- Fibromyalgia, Lipedema
- Being tested
- Presence and stages of lipedema were diagnosed with examination.
- Keywords
- fibromyalgia, lipedema, awareness
- Medical subject headings
- Fibromyalgia, Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presence and stages of lipedema were diagnosed with examination.Other
Lipedema stage characteristics: stage 1: Smooth skin with a uniform increase in subcutaneous tissue; stage 2: Irregular skin surface with indentations and nodular alterations in the subcutaneous tissue; stage 3: Significant increase in circumference accompanied by loose skin/tissue ('dewlap').
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
Patients were asked to mark the severity of their widespread body pain in the last week on a 10 cm visual analog scale (VAS) (0: no pain, 10: unbearable pain, the higher the measured value, the greater the pain intensity).
Measured: 1 month
Presence and stages of lipedema were diagnosed according to S1 guidelines of the German Society of Phlebology
Overview of diagnostic criteria for lipedema; Initiation during puberty, pregnancy, or menopause, characterized by disproportionate proliferation of adipose tissue (extremities, trunk), cuffing around the joints, unaffected hands and feet, sensations of heaviness and tightness in the affected extremities, tenderness upon palpation or spontaneous pain - escalating throughout the day, edema - worsening over the course of the day, easy bruising, and a negative Stemmer's sign. Lipedema stage characteristics: stage 1: Smooth skin with a uniform increase in subcutaneous tissue; stage 2: Irregular skin surface with indentations and nodular alterations in the subcutaneous tissue; stage 3: Significant increase in circumference accompanied by loose skin/tissue ('dewlap').
Measured: 1 month
The American College of Rheumatology (ACR) 2016 Fibromyalgia Diagnostic Criteria
It is a compilation of diagnostic criteria formulated for the identification of fibromyalgia, established following the modification of previously utilized diagnostic criteria. It comprises two components: the widespread pain index (WPI) and the symptom severity scale (SSS).
The assessment of the WPI involves indicating persistent pain over the past seven days across five anatomical regions (upper left, upper right, lower left, lower right, axial) and 19 specific body areas (both jaws, shoulders, upper arms, lower arms, hips, upper legs, lower legs, neck, upper back, lower back, chest, and abdomen). Each region is assigned one point. The cumulative score varies from 0 to 19. For a diagnosis of widespread pain, pain must be evident in a minimum of 4 out of 5 anatomical regions.
Measured: 1 month
The Revised Fibromyalgia Impact Questionnaire
It is a questionnaire designed to assess functional limitations and disabilities resulting from fibromyalgia. The questionnaire comprises a total of 21 questions divided into three sections: function, overall impact, and symptoms. Responses to each inquiry are indicated on a scale ranging from 0 to 10. The overall score is determined by summing the results: the score of the first section is divided by three, the score of the second section by one, and the score of the third section by two. Elevated scores signify a greater fibromyalgia-associated impairment
Measured: 1 month
Beck Depression Inventory
It is a scale designed to assess the intensity and severity of depression symptoms. The scale comprises 21 items utilizing a 4-point Likert format, with each item rated from 0 to 3. Higher scores indicate more severe depressive symptoms
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Aug 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzem Bolkan Günaydın, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749379
- Sponsor's protocol ID
- 20/07/2022/20.478.486/1424
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIPEDEMA AWARENESS IN FIBROMYALGIA
- ClinicalTrials.gov ID
- NCT06749379
- Acronym / sponsor ID
- 20/07/2022/20.478.486/1424
- Conditions
- Fibromyalgia, Lipedema
- Keywords
- fibromyalgia, lipedema, awareness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 27 Dec 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.
Lipedema is a chronic debilitating condition that impacts the subcutaneous adipose tissue of the extremities. It is a chronic condition but should not be regarded as always progressing.The clinical course varies individually and is unpredictable. It may considerably diminish the patient's quality of life. Fibromyalgia, similar to lipedema, is a debilitating chronic pain disease of unclear origin that primarily affects women. It is a complex syndrome marked by widespread pain and tenderness. Fibromyalgia and lipedema are both marked by pain related to soft tissue. Both disorders are not amenable to curative treatment, resulting in a significant burden on individual and public health. No definitive indicators, including abnormal laboratory or imaging results, can be discerned to differentiate one disorder from another.
With this perspective, the aim of our study was to evaluate the presence of lipedema and lipedema-related factors in fibromyalgia patients.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study included 100 female patients over the age of 18 who met the fibromyalgia diagnostic criteria according to the American College of Rheumatology (ACR) 2016 Fibromyalgia Diagnostic Criteria.
Key inclusion criteria (3 listed)
- female patients
- over the age of 18
- who met the fibromyalgia diagnostic criteria according to the American College of Rheumatology (ACR) 2016 Fibromyalgia Diagnostic Criteria
Key exclusion criteria (3 listed)
- renal or cardiac insufficiency,
- the use of any drug that could influence body fluid and electrolyte balance,
- the presence of a major somatic disease.
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 |
|---|---|---|
| Presence and stages of lipedema were diagnosed with examination.Lipedema stage characteristics: stage 1: Smooth skin with a uniform increase in subcutaneous tissue; stage 2: Irregular skin surface with indentations and nodular alterations in the subcutaneous tissue; stage 3: Significant increase in circumference accompanied by loose skin/tissue ('dewlap'). | Other | – |
Primary outcome
visual analog scale
Time frame: 1 month
Patients were asked to mark the severity of their widespread body pain in the last week on a 10 cm visual analog scale (VAS) (0: no pain, 10: unbearable pain, the higher the measured value, the greater the pain intensity).
Presence and stages of lipedema were diagnosed according to S1 guidelines of the German Society of Phlebology
Time frame: 1 month
Overview of diagnostic criteria for lipedema; Initiation during puberty, pregnancy, or menopause, characterized by disproportionate proliferation of adipose tissue (extremities, trunk), cuffing around the joints, unaffected hands and feet, sensations of heaviness and tightness in the affected extremities, tenderness upon palpation or spontaneous pain - escalating throughout the day, edema - worsening over the course of the day, easy bruising, and a negative Stemmer's sign. Lipedema stage characteristics: stage 1: Smooth skin with a uniform increase in subcutaneous tissue; stage 2: Irregular skin surface with indentations and nodular alterations in the subcutaneous tissue; stage 3: Significant increase in circumference accompanied by loose skin/tissue ('dewlap').
The American College of Rheumatology (ACR) 2016 Fibromyalgia Diagnostic Criteria
Time frame: 1 month
It is a compilation of diagnostic criteria formulated for the identification of fibromyalgia, established following the modification of previously utilized diagnostic criteria. It comprises two components: the widespread pain index (WPI) and the symptom severity scale (SSS). The assessment of the WPI involves indicating persistent pain over the past seven days across five anatomical regions (upper left, upper right, lower left, lower right, axial) and 19 specific body areas (both jaws, shoulders, upper arms, lower arms, hips, upper legs, lower legs, neck, upper back, lower back, chest, and abdomen). Each region is assigned one point. The cumulative score varies from 0 to 19. For a diagnosis of widespread pain, pain must be evident in a minimum of 4 out of 5 anatomical regions.
The Revised Fibromyalgia Impact Questionnaire
Time frame: 1 month
It is a questionnaire designed to assess functional limitations and disabilities resulting from fibromyalgia. The questionnaire comprises a total of 21 questions divided into three sections: function, overall impact, and symptoms. Responses to each inquiry are indicated on a scale ranging from 0 to 10. The overall score is determined by summing the results: the score of the first section is divided by three, the score of the second section by one, and the score of the third section by two. Elevated scores signify a greater fibromyalgia-associated impairment
Beck Depression Inventory
Time frame: 1 month
It is a scale designed to assess the intensity and severity of depression symptoms. The scale comprises 21 items utilizing a 4-point Likert format, with each item rated from 0 to 3. Higher scores indicate more severe depressive symptoms
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 27 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fibromyalgia and Lipedema, run by Ufuk 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 27 Dec 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?
visual analog scale (time frame: 1 month). The study lists 5 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 27 Dec 2024.