Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-27 @ 5:13 PM
Study NCT ID:
NCT06145204
Status:
COMPLETED
Last Update Posted:
2025-06-24
First Post:
2023-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Volume and Pain in Lower Limbs Lymphoedema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2023-08-07', 'studyFirstSubmitQcDate': '2023-11-20', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain assessment using questionnaires: Lymph-iCf-LL', 'timeFrame': 'at the beginning (Day 0) and the end (Day 4) of the cure', 'description': 'we will compare the results in % between the beginning and the end of the cure'}, {'measure': 'pain assessment using questionnaires: OMSPQ', 'timeFrame': '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)', 'description': 'we will compare the results in % between the beginning and the end of the cure and the beginning of the next cure'}, {'measure': 'pain assessment using questionnaires: BPI-sf', 'timeFrame': '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)', 'description': '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pain', 'volume', 'adult'], 'conditions': ['Lymphedema, Lower Limb']}, 'descriptionModule': {'briefSummary': "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.\n\nOne 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.\n\nAt 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.\n\nThe 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.\n\nTo 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 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.\n\nExclusion Criteria:\n\n* Patient under 18 years of age\n* Pain not related to lymphoedema\n* Inability to read and understand French to answer questionnaires\n* Patient with infection of the lower limb(s)'}, 'identificationModule': {'nctId': 'NCT06145204', 'briefTitle': 'Correlation Between Volume and Pain in Lower Limbs Lymphoedema', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Mont-Godinne'}, 'officialTitle': 'Effect of Complex Decongestive Therapy and Correlation Between Volume and Pain in Lower Limb Lymphedema: a Prospective Study', 'orgStudyIdInfo': {'id': 'B0392022000072'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'single-group', 'description': '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.\n\nThere 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.', 'interventionNames': ['Other: questionnaire']}], 'interventions': [{'name': 'questionnaire', 'type': 'OTHER', 'description': 'anamnesis, OMSPQ, Brief Pain Inventory-short form, lymph-ICF-LL', 'armGroupLabels': ['single-group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5530', 'city': 'Yvoir', 'state': 'Namur', 'country': 'Belgium', 'facility': 'CHU UCL Namur site Godinne', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Mont-Godinne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professeur clinique', 'investigatorFullName': 'Deltombe Thierry', 'investigatorAffiliation': 'University Hospital of Mont-Godinne'}}}}