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Completed

NCT Number: NCT06145204

Correlation Between Volume and Pain in Lower Limbs Lymphoedema

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU UCL Namur site Godinne

Yvoir, Namur, 5530, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Questionnaire

Other

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

Primary outcomes

  1. pain assessment using questionnaires: Lymph-iCf-LL

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

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

  2. pain assessment using questionnaires: OMSPQ

    Time frame: 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)

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

  3. pain assessment using questionnaires: BPI-sf

    Time frame: 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)

    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

Sponsors and collaborators

Lead sponsor

University Hospital of Mont-Godinne

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 24, 2023
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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