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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia; Lipedema
• Intervention / Treatment: Other: Presence and stages of lipedema were diagnosed with examination.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06510
    • Ufuk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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').	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.	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	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	1 month

Collaborators and Investigators

• Sponsor: Ufuk University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: fibromyalgia, lipedema, awareness
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Connective Tissue Diseases; Fibromyalgia; Myofascial Pain Syndromes; Lipedema
• Other Study ID Numbers: 20/07/2022/20.478.486/1424

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No