lipedema
Conditions
Interventions
Group 1: Women without lipedema (control) to investigate the sensitivity and specificity of the pressure pain and vibration detection thresholds assessed at the hand and the thigh in distinguishing be
Sponsors
Translationale Schmerzforschung, Uniklinik Köln
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Female • Age 18 or older • For patients with a confirmed medical diagnosis of lipedema: o Definition of lipedema according to the AWMF S2K guideline: “Lipedema is a painful, disproportionate, symmetrical disorder of fat distribution in the extremities that occurs almost exclusively in women. Symptoms characteristic of lipedema include pain upon pressure or touch, spontaneous pain, and a sensation of heaviness.” o Defined as “normal weight” by WHtR • For healthy, normal-weight control subjects: o No history of any of the following diagnoses: obesity, lymphedema, lipohypertrophy dolorosa, lipohypertrophy o WHtR defines “normal weight” as • A signed and irrevocable informed consent form
Exclusion criteria
Exclusion criteria: • The presence of an (additional) medical diagnosis within the field of lipo- and lymphology (e.g., lymphedema, lipohypertrophy, etc.) • Limited ability to communicate (language barriers, cognitive barriers, …) • Conditions that affect the sensory nervous system (e.g., Parkinson’s disease, multiple sclerosis, radiculopathy, injuries to nerves innervating the measurement area of various origins, diabetes mellitus, diabetic polyneuropathy, peripheral polyneuropathies of various origins, etc.) • Diagnosed depression • Administration of testosterone preparations • Ongoing oncological treatment • Skin irritation at the measurement sites • Topical application of analgesics at the measurement sites (e.g., patches, creams, …) • Diagnosed coagulation disorder or wound-healing disorder • Other known changes in pain perception or another diagnosed pain disorder • Liposuction performed prior to study enrollment • Pregnancy, breastfeeding • Previous enrollment in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to determine the sensitivity and specificity of the PVTH score we proposed in our previous publication in distinguishing between normal-weight patients with lipedema and normal-weight healthy controls in a larger, independent sample. Specifically, we will test whether a PVTH score of 3.8 can identify participants as healthy controls or lipedema patients with a sensitivity of more than 70% and a specificity of more than 70%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Next, the PVTH scores are calculated, which allow for the classification of control vs. patient with a sensitivity and/or specificity of 80% and 90%, respectively. In addition, the calculated PVTH score is compared with pain assessments commonly used in clinical practice, such as the German Pain Society’s pain questionnaire. Does the magnitude of the change correlate with variables measured by the questionnaire, such as pain intensity, depression, or limitations in daily life? | — |
Countries
Germany
Contacts
Public ContactTim Hucho
Translationale Schmerzforschung, Uniklinik Köln
Outcome results
None listed