Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-01 @ 4:23 AM
Study NCT ID:
NCT04580069
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2020-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Two Rehabilitative Treatments and Diet in the Modulation of Inflammation in Patients With Knee Prosthesis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073297', 'term': 'Manual Lymphatic Drainage'}], 'ancestors': [{'id': 'D008405', 'term': 'Massage'}, {'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004322', 'term': 'Drainage'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-07', 'studyFirstSubmitDate': '2020-09-30', 'studyFirstSubmitQcDate': '2020-10-07', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CRP variation', 'timeFrame': '21 days', 'description': 'blood test'}, {'measure': 'ESR variation', 'timeFrame': '21 days', 'description': 'blood test'}, {'measure': 'lower limb oedema', 'timeFrame': '21 days', 'description': 'leg circumference'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['total Knee Arthroplasty (TKA)', 'C-reactive protein (CRP)', 'erythrosedimentation rate (ESR)', 'Over Knee Oedema (EDO)', 'Under Knee Oedema (EDU)', 'MEDIET Questionnaire'], 'conditions': ['Knee Pain Swelling']}, 'referencesModule': {'references': [{'pmid': '34099953', 'type': 'DERIVED', 'citation': 'Rigoni S, Tagliaro L, Bau D, Scapin M. Effectiveness of two rehabilitation treatments in the modulation of inflammation during the acute phase in patients with knee prostheses and assessment of the role of the diet in determining post-surgical inflammation. J Orthop. 2021 May 15;25:237-243. doi: 10.1016/j.jor.2021.05.016. eCollection 2021 May-Jun.'}]}, 'descriptionModule': {'briefSummary': 'The investigators studied the influence of two aproved rehabilitative treatments, connective tissue techniques and lymphatic drainage, on acute inflammation markers. Furthermore, the role of mediterranean diet on the same values was investigated in the first postoperative period', 'detailedDescription': 'The main objective of this study is to demonstrate the effectiveness of lymphatic drainage and connective tissue techniques in modulating systemic inflammation. Another objective is to evaluate the existence, at baseline, of a correlation between the inflammation indices and the level of adherence to the Mediterranean diet.\n\nMethods. 34 patients were recruited, and divided into three groups. The control group followed the normal rehabilitation protocol. The other two groups were subjected, in addition to the standard treatment, to manual lymphatic drainage treatment or connective tissue techniques. The outcomes (PCR, ESR, Oedema) were recorded in three stages: upon entering the hospital, 1 week after entry and at follow-up 21 days after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* 50\\<age\\<80 years\n* Bicompartmental knee arthroplasty\n* Weight bearing 7 days after surgery\n* Transfusions according to hospital protocol\n* Alteration of the indices at T0\n* Standard analgesic therapy\n\nExclusion Criteria:\n\n* Joint replacements from other Units\n* Inflammatory arthropathies\n* Autoimmune / rheumatic diseases\n* Obesity\n* Diabetes mellitus\n* Infections'}, 'identificationModule': {'nctId': 'NCT04580069', 'briefTitle': 'Role of Two Rehabilitative Treatments and Diet in the Modulation of Inflammation in Patients With Knee Prosthesis.', 'organization': {'class': 'OTHER', 'fullName': 'Presidio Ospedaliero di Asiago'}, 'officialTitle': 'Effectiveness of Two Rehabilitative Treatments in the Modulation of Inflammation During the Acute Phase in Patients With Knee Prosthesis and Assessment of the Role of the Diet in Determining Post-surgical Inflammation.', 'orgStudyIdInfo': {'id': 'POAsiago'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lymphatic drainage', 'description': 'Patients subjected to manual lymphatic drainage', 'interventionNames': ['Procedure: Lymphatic drainage']}, {'type': 'EXPERIMENTAL', 'label': 'Connective tissue', 'description': 'Patients subjected to connective tissue massage', 'interventionNames': ['Procedure: Lymphatic drainage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'Subjects hat followed standard rehabilitative treatment', 'interventionNames': ['Procedure: Lymphatic drainage']}], 'interventions': [{'name': 'Lymphatic drainage', 'type': 'PROCEDURE', 'otherNames': ['Connective tissue massage'], 'description': 'The interventions follow the validated techniques normally used in international rehabilitation', 'armGroupLabels': ['Connective tissue', 'Lymphatic drainage', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36012', 'city': 'Asiago', 'state': 'Vicenza', 'country': 'Italy', 'facility': 'presidio ospedaliero di Asiago', 'geoPoint': {'lat': 45.87588, 'lon': 11.51223}}, {'zip': '36012', 'city': 'Asiago', 'state': 'Vicenza', 'country': 'Italy', 'facility': 'ULSS 7 Pedemontana', 'geoPoint': {'lat': 45.87588, 'lon': 11.51223}}], 'overallOfficials': [{'name': 'Sergio Rigoni', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Presidio Ospedaliero di Asiago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Presidio Ospedaliero di Asiago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sergio Rigoni', 'investigatorFullName': 'Sergio Rigoni', 'investigatorAffiliation': 'Presidio Ospedaliero di Asiago'}}}}