Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06145204
Enrollment
79
Registered
2023-11-24
Start date
2023-12-11
Completion date
2024-12-13
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema, Lower Limb

Keywords

pain, volume, adult

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.

Interventions

OTHERquestionnaire

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

Sponsors

University Hospital of Mont-Godinne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
pain assessment using questionnaires: Lymph-iCf-LLat the beginning (Day 0) and the end (Day 4) of the curewe will compare the results in % between the beginning and the end of the cure
pain assessment using questionnaires: OMSPQat 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
pain assessment using questionnaires: BPI-sfat 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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026