NCT06145204

Correlation Between Volume and Pain in Lower Limbs Lymphoedema

Effect of Complex Decongestive Therapy and Correlation Between Volume and Pain in Lower Limb Lymphedema: a Prospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 79 (actual)
• Sponsor: University Hospital of Mont-Godinne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 two validated questionnaires (Brief Pain Inventory - short version and Orebro Musculoskeletal Pain Screening Questionnaire (OMSPQ) - short version) at D0 (start of complex decongestion therapy), D4 (end of complex decongestion therapy) and M3-8 (start of next complex decongestion therapy). No interventions or measures other than those used in clinical practice will be added.

Conditions

• Lymphedema, Lower Limb

Interventions

Type	Name	Description
OTHER	questionnaire	anamnesis, OMSPQ, Brief Pain Inventory-short form, lymph-ICF-LL

Timeline

• Start date: 2023-12-11
• Primary completion: 2024-12-13
• Completion: 2024-12-13
• First posted: 2023-11-24
• Last updated: 2025-06-24

Locations

1 site across 1 country: Belgium