NCT07808242

Brief Summary

The aim of this observational study is to determine the prevalence of joint hypermobility in female patients with lipedema compared to healthy volunteers. Additionally, the study investigates how the presence of hypermobility in lipedema patients relates to the clinical and ultrasonographic stage of the disease, regional pain severity, pain sensitivity, postural status (such as genu valgum and foot overpronation), quality of life, and physical activity levels. The study includes 65 female patients clinically diagnosed with lipedema and 65 healthy female volunteers matched for age and body mass index.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

7 months

First QC Date

August 31, 2026

Last Update Submit

September 6, 2026

Conditions

Keywords

Joint HypermobilityBeighton ScoreLipedemaConnective Tissue Laxity

Outcome Measures

Primary Outcomes (1)

  • Beighton Score

    The Beighton Scoring System is used to assess generalized joint hypermobility. Total scores range from a minimum of 0 to a maximum of 9. A higher score indicates a greater degree of joint hypermobility (a worse outcome). A score of 5 or higher is considered positive for generalized joint hypermobility.

    Baseline (measured at the time of enrollment)

Secondary Outcomes (6)

  • Pain Intensity

    Baseline

  • Algometric Assessment

    Baseline

  • Subcutaneous Adipose Tissue Thickness

    Baseline

  • Nottingham Health Profile (NHP)

    Baseline

  • International Physical Activity Questionnaire - Short Form (IPAQ-SF)

    Baseline

  • +1 more secondary outcomes

Study Arms (2)

Lipedema Group

Women diagnosed with lipedema according to clinical criteria.

Control Group

Healthy female volunteers matched for age and BMI, without lipedema diagnosis.

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lipedema Group: Female patients, aged between 18 and 65 years, who were clinically diagnosed with lipedema based on detailed physical examination and clinical assessments. The participants were evaluated and recruited at the Dokuz Eylul University Faculty of Medicine, Department of Physical Medicine and Rehabilitation Outpatient Clinic. Control Group: Healthy female volunteers, aged between 18 and 65 years, who were strictly matched to the lipedema group in terms of age and Body Mass Index (BMI).

You may qualify if:

  • For Lipedema Group:
  • Aged between 18-65 years. Diagnosed with lipedema. Willing to participate in the study. Having a socio-cultural level suitable for study participation.
  • For Control Group:
  • Aged between 18-65 years. Willing to participate in the study. Having a socio-cultural level suitable for study participation.

You may not qualify if:

  • For Lipedema Group:
  • Uncontrolled thyroid dysfunction. Chronic venous insufficiency and/or lymphedema (Stage 4 lipedema). Acute or chronic renal failure. Heart failure. Active cancer or ongoing cancer treatment. Presence of neurological disease. Presence of rheumatological disease. History of liposuction or major surgery for lipedema within the last 6 months. Visual or hearing impairment severe enough to affect study compliance. Illiteracy or cognitive impairment preventing the ability to give written informed consent.
  • For Control Group:
  • Previous diagnosis of lipedema, lymphedema, chronic venous insufficiency. History of rheumatologic, neurologic, endocrinologic, or cardiovascular diseases.
  • Uncontrolled thyroid dysfunction. History of acute or chronic renal failure, heart failure, active cancer, or ongoing cancer treatment.
  • Orthopedic problems affecting lower extremities, trauma, or history of liposuction/major surgery within the last 6 months.
  • Regular use of medications that may affect pain threshold (e.g., systemic corticosteroids, antidepressants, anticonvulsants, etc.).
  • Physical barriers affecting pain assessment (algometry, VAS) or postural observation (e.g., severe vision/hearing loss, local skin lesions, amputation, etc.).
  • Cognitive impairment or lack of literacy preventing written informed consent. Psychiatric illness preventing compliance with the study process or communication problems affecting cooperation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University Faculty of Medicine Hospital

Izmir, 35330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

LipedemaJoint Instability

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesJoint DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 8, 2026

Study Start

August 15, 2025

Primary Completion

March 15, 2026

Study Completion

April 15, 2026

Last Updated

September 8, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect participant privacy and maintain data confidentiality. The informed consent forms approved by the local Ethics Committee explicitly state that personal clinical data will be kept confidential and will not be shared with third-party researchers. Therefore, only aggregated data will be reported in publications.

Locations