Clinical trial NCT06145204: Correlation Between Volume and Pain in Lower Limbs Lymphoedema
Official title: Prospective Non-interventional Study of Adult Patients With Lymphoedema of One or Both Lower Limbs : Is There a Correlation Between Variations in the Volume of Their Lymphoedema and Their Pain?
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lymphedema, Lower Limb
Keywords: pain
volume
adult
Lead sponsor: University Hospital of Mont-Godinne
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 three validated questionnaires (Brief Pain Inventory - short version, Orebro Musculoskeletal Pain Screening Questionnaire (OMSPQ) - short version and the DN4 scale) at D0 (start of complex decongestion therapy) and D4 (end of complex decongestion therapy). No interventions or measures other than those used in clinical practice will be added.


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)

Primary outcomes:
measure: pain assessment using questionnaires: Lymph-iCf-LL
timeFrame: at the beginning (Day 0) and the end (Day 4) of the cure
measure: pain assessment using questionnaires: OMSPQ
timeFrame: at the beginning (Day 0) and the end (Day 4) of the cure
measure: pain assessment using questionnaires: BPI-sf
timeFrame: at the beginning (Day 0) and the end (Day 4) of the cure
measure: pain assessment using questionnaires: DN4
timeFrame: at the beginning (Day 0) and the end (Day 4) of the cure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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