Lipedema (LI) is a chronic condition, painful disease characterized by a disproportionate increase in adipose tissue and pain in women's legs and sometimes arms. Its prevalence is largely unknown, but lipedema is estimated to affect 0.06% to 11% of the female population. Even though this pathology is increasingly studied and working groups are collaborating to harmonize criteria, a crucial underlying problem of lipedema is the variability in identifying lipedema. Lipedema patients often suffer from obesity, physical disability and psychological impairments, and the effects on quality of life are significant. Almost all women with lipedema are dissatisfied with the disproportionality of their body and the stigma associated with it. In addition to weight gain, pain is one of the major symptoms of this pathology, but also limb heaviness, weakness, or difficulties with walking. Patients also tend to develop easy bruising, although these symptoms are not always present. Treatment of lipedema is aimed at relieving pain, maintaining/improving mobility, reducing volume of the limbs, and improving quality of life. It is important to note that compression therapy is one of the cornerstones of this treatment because of its anti-inflammatory effect on adipose tissue
Lipedema diagnosed at least in the legs according to the initial Wold criteria modified by Herbst.
Average pain in the legs over the last week ≥ 4 points on a 10 points Numerical Rating Scale visual analogue scale.
Patient who has given his informed consent freely and signed it prior to any intervention in the study.
Patient for whom compression is contraindicated, such as untreated infections, skin irritation or lesions.
Lipedema type I: Hips/buttocks.
Patients who underwent liposuction.
Patient with a WHtR higher than 0,58.
Single group
compression group
DeviceAll patients enrolled in the study will be instructed to wear the compression garment for 8 weeks, as long as possible during the day. In parallel, all patients will receive the same advice about routine care: physical exercises, nutrition aspect that are part of the centre's current practice. 3 study visits are planned: the inclusion visit (V0) includes patient information and consent signature, measurements for custom-made compression stockings. The initial visit (V1) includes devices collection and fitting, patient questionnaires, physician assessment (medical and lipedema history, BMI, WHtR, blood sample collection, pain description, lipedema associated symptoms, leg perimeter measurements, Moisture Meter, pressure under the garment). The follow-up visit (V2) after 8 weeks includes: patient questionnaires and physician assessment. After 8 weeks, another compression garment will be given to the patient with a new satisfaction e-questionnaire at 10 weeks of follow-up.
Evolution of pain: Numeric Rating Scale (NRS)
The evolution of perceived leg pain (mean and maximum) related to lipedema is measured by Numeric Rating Scale (NRS). 0 corresponds to no pain and 10 to the maximum pain.
Evolution of pain threshold under pressure (algometer)
The pain threshold under pressure is measured by an algometer. It is a non-invasive and painless instrument that consists of a dial, a cylinder attached to the dial, and a rod inside the cylinder, which ends in a 1 cm2 rubber tip.
Quality of life (QoL): Patient's opinion on Global Impression of Change (PGI-C)
The patient's impression of overall change is measured by the Patient's opinion on Global Impression of Change questionnaire (PGI-C). The scale has 7 levels of response : "no change or condition has got worse" that is the worst outcome (= 1 point) "almost the same, hardly any change at all" (= 2 points); "a little better , but no noticeable change" (= 3 points); "somewhat better, but the change has not made any real difference" (= 4 points); "moderately better, and a slight but noticeable change" (= 5 points); "better, and a definite improvement that has made a real and worthwhile difference (=6 points); "A great deal better, and a considerable improvement that has made all the diiference" (=7 points). The highest score corresponds to the most improvement in quality of life.
Evolution of quality of life (QoL): the Patient Benefit Index (PBI-L)
The evolution of QoL related to the lipedema is measured by the PBI-L self-questionnaire. It consists of 23 questions about different area: quality of life, physical, psychological. It consists of 2 questionnaires : before therapy and after therapy. The patient rates the extent to which the treatment objectives have been achieved. Questions are scaled from 0 'not important at all' to 4 'very important' with a response option 'does not apply to me'.
Evolution of lipedema-associated symptoms: Numeric Rating Scale (NRS)
The evolution of swelling, tightness, discomfort, heaviness, skin suppleness, fatigue due to lipedema is measured by NRS : 0 corresponds to no symptom and 10 to maximum symptom
This trial is not recruiting at the moment. You can still explore other options:
