Evaluation of pain (Numeric Rating Scale (NRS) under flat knitted medical compression of the lower extremities in patients with lipedema (explorative study)
- Conditions
- E88.28
- Registration Number
- DRKS00031131
- Lead Sponsor
- eurocom e.V. (european manufacturers federation for compression therapy and orthopaedic devices)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 24
written informed consent
- female of at least 18 years of age
- confirmed diagnosis of lipedema
- no contraindication against flat-knitted compression garnment
- expected good compliance in regards to wearing compression stockings ( at least 6 hours per day on at least 6 days a week) and study-related activties (study visits, completion of ePRO)
- actual pain in the leg of at least 4.0 on the NRS at V0
daily access to smartphne, tablet or PC for using ePRO
- pregnant or breast feeding women
- women of childbearing potential who intend to become pregnant during study conduct
- isolated lipedema in the lower leg without participation of upper leg
-diagnosis lymphedema, plebedema or myxedema
- use of flat-knitted compression therapy for the management of the lipedema in the 4 weeks before study inclusion as well as in the time between inclusion and handover of test product
-actual or planned therapy of the lipedema (including psychotherapy, manual lymph drainage, physio therapy etc)
- planned liposuction within the next 3-6 months
- already occured liposuction
- patients who have requested disability pension benefit or plan to do so
-any pain causing comorbidities, which will interfere with the pain symptomatic of the lipedema
- advanced arterial occlusive disease defined as ABPI < 0,5, pressure in arteria of the ankle < 60 mmHg, toe pressure < 30 mmHg oder TcPO2 < 20 mmHg footback
-decompensated heart insufficiency (NYHA III+IV)
- septic superficial vein thrombosis (phlebitis)
-phlegmasia coerula dolens
- presence of one or several of following risks: intensive weeping dermatosis, intolerability to the compression material, severe sensibility disturbance of the extremity, advanced peripheral neuropathy (e.g. in diabetes mellitus), primary chronic polyarthritis
- comorbidities which in the judgement of the investigator influences or interferes with the assessment of the study endpoint
- alcohol- or drug abuse
-regular pain treatment (e.g. medication)
-particpation in another clinical study (actual or within the last 4 weeks)
-study participation who are dependent on sponsor, manufacturer, CRO or site
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute and percentage change of pain evaluation via numeric rating scale ((NRS), scale 1-10) during the study conduct
- Secondary Outcome Measures
Name Time Method *Change of Intensitiy of pain (measured via NRS) in comparison to baseline at following timepoints:<br>- 15 min afere first wearing of compression garnments at visit 1<br>- after at least 6 hours of wearing the compression garnments continously on days 1 to 27 at V2<br>*Change of quality of life in comprasion to baseline alue at visit 0, measured with<br>- SF-36 on days 7, 14, 21, 28<br>Lymph-ICF-UG questionnaire (disturbance, limitiations and problem in participation, questionnaire für lymphedema of the lower extremities) on days 14 and 28, and<br>-the WHO qulaity of life-abbreviated version of WHOQOL 10 (WHOQOL-BREF) on days 14 and28<br>*Change of the weekly average number of steps, measured via a fitness tracker, in comparison to baseline<br>* tolerability<br><br><br>