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Completed

NCT Number: NCT06749379

LIPEDEMA AWARENESS IN FIBROMYALGIA

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.

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Key information

Conditions

Fibromyalgia Connective Tissue Diseases Lipedema Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Ufuk University

Ankara, 06510, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • renal or cardiac insufficiency,
  • the use of any drug that could influence body fluid and electrolyte balance,
  • the presence of a major somatic disease.

Treatment and study plan

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').

Primary outcomes

  1. 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).

  2. 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').

  3. 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.

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Ufuk University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 27, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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