Correlation Between Volume and Pain in Lower Limbs Lymphoedema

NCT ID: NCT06145204

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 79 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-11
• Study Completion Date: 2024-12-13

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

single-group

Adult patients suffering from lymphoedema of one or both lower limbs, capable of expressing their wishes and cared for their pathology at the Godinne Lymphoedema Reference Center.

There is no intervention (observational study). Questionnaires will be given at the beginning (Day 0) and the end (Day 4) of the cure and at the start of next cure (Month 3 to 8) : Lymph-iCf-LL, OMSPQ, BPI-sf.

questionnaire

Intervention Type: OTHER

anamnesis, OMSPQ, Brief Pain Inventory-short form, lymph-ICF-LL

Interventions

questionnaire

anamnesis, OMSPQ, Brief Pain Inventory-short form, lymph-ICF-LL

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients with lymphoedema of one or both lower limbs diagnosed by three-stage lymphoscintigraphy, or clinically if it is medically impossible to perform three-stage lymphoscintigraphy for good reason.

Exclusion Criteria

• Patient under 18 years of age
• Pain not related to lymphoedema
• Inability to read and understand French to answer questionnaires
• Patient with infection of the lower limb(s)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Mont-Godinne

OTHER

Sponsor Role: lead

Responsible Party

Deltombe Thierry

Professeur clinique

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHU UCL Namur site Godinne

Yvoir, Namur, Belgium

Countries

Belgium

Other Identifiers

B0392022000072

Identifier Type: -

Identifier Source: org_study_id