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Clinical Trial Summary

The vascular physiotherapy department of the UCL University Clinics of Mont-Godinne specializes in the physiotherapeutic management of lymphoedema. Since 2018, an agreement has been established with INAMI to evaluate the effect of complex decongestion therapy on lymphoedema and its impact on patients' quality of life. One of the aims of the treatment is to reduce the volume of lymphoedema and the discomfort or even pain associated with it. More generally, pain can have a significant functional impact, especially when it becomes chronic. As pain is subjective and influenced by many factors, it is difficult to assess it. Therefore it is interesting to consider psychosocial factors when assessing pain, in order to propose a global management approach. At Mont-Godinne, pain-related data is currently collected on a numerical scale from 0 to 10, using the Lymph-ICF questionnaire. Moreover, in Belgium, reimbursement for lymphoedema care in the form of pathology E or F is based mainly on volume measurements. The main aim of this study is to identify correlations between lymphoedema volume and pain related to lower limbs and to determine if pain could reduced when lymphoedema volume is decreased using current therapy. The second objective is collecting demographic data to assess the need for a comprehensive, specific and systematic approach to pain in the management of lymphoedema. To proceed this assessment, we have sought the opinion of the Ethics Committee regarding the anonymous collection of new data from patients treated via a medical history and the introduction of three validated questionnaires (Brief Pain Inventory - short version, Orebro Musculoskeletal Pain Screening Questionnaire (OMSPQ) - short version and the DN4 scale) at D0 (start of complex decongestion therapy) and D4 (end of complex decongestion therapy). No interventions or measures other than those used in clinical practice will be added.


Clinical Trial Description

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NCT number NCT06145204
Study type Observational
Source University Hospital of Mont-Godinne
Contact Thierry Deltombe, MD
Phone +3281423772
Email thierry.deltombe@chuuclnamur.uclouvain.be
Status Not yet recruiting
Phase
Start date December 11, 2023
Completion date June 7, 2024