Correlation Between Volume and Pain in Lower Limbs Lymphoedema

NCT06145204 | Completed

• 1 other identifier: B0392022000072
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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

Keywords

pain; volume; adult

Outcome Measures

Primary Outcomes (3)

• pain assessment using questionnaires: Lymph-iCf-LL

  we will compare the results in % between the beginning and the end of the cure

  at the beginning (Day 0) and the end (Day 4) of the cure

• pain assessment using questionnaires: OMSPQ

  we will compare the results in % between the beginning and the end of the cure and the beginning of the next cure

  at the beginning (Day 0) and the end (Day 4) of the cure and at the beginning of the next cure (Month 3 to 8)

• pain assessment using questionnaires: BPI-sf

  we will compare the results between the beginning and the end of the cure and the beginning of the next cure with two scores: intensity and interference score

  at the beginning (Day 0) and the end (Day 4) of the cure and at the beginning of the next cure (Month 3 to 8)

Study Arms (1)

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.

Other: questionnaire

Interventions

questionnaire OTHER

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

single-group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• \- 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital of Mont-Godinne: lead

Study Sites (1)

CHU UCL Namur site Godinne

Yvoir, Namur, 5530, Belgium

Location

MeSH Terms

Conditions

Lymphedema; Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professeur clinique

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: November 24, 2023
• Study Start: December 11, 2023
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2024
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)