Lymphedema, Lower LimbNCT06145204
Correlation Between Volume and Pain in Lower Limbs Lymphoedema
An observational study of Lymphedema, Lower Limb, run by University Hospital of Mont-Godinne at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema, Lower Limb
- What is being tested?
- questionnaire
- How many people
- 79 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Dec 2023to 13 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Complex Decongestive Therapy and Correlation Between Volume and Pain in Lower Limb Lymphedema: a Prospective Study
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.
Read more
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
- Being tested
- questionnaire
- Keywords
- pain, volume, adult
- Medical subject headings
- Lymphedema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
anamnesis, OMSPQ, Brief Pain Inventory-short form, lymph-ICF-LL
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain assessment using questionnaires: Lymph-iCf-LL
we will compare the results in % between the beginning and the end of the cure
Measured: 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
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start11 Dec 2023
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema, Lower LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Mont-Godinne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deltombe Thierry, University Hospital of Mont-Godinne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145204
- Sponsor's protocol ID
- B0392022000072
- Status last verified
- Jun 2025
- First submitted
- 7 Aug 2023
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Complex Decongestive Therapy and Correlation Between Volume and Pain in Lower Limb Lymphedema: a Prospective Study
- ClinicalTrials.gov ID
- NCT06145204
- Acronym / sponsor ID
- B0392022000072
- Conditions
- Lymphedema, Lower Limb
- Keywords
- pain, volume, adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital of Mont-GodinneUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-group | – | Other: questionnaireAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireanamnesis, OMSPQ, Brief Pain Inventory-short form, lymph-ICF-LL | Other | single-group |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema, Lower Limb, run by University Hospital of Mont-Godinne at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain assessment using questionnaires: Lymph-iCf-LL (time frame: at the beginning (Day 0) and the end (Day 4) of the cure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.