Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT06239805
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2023-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quantum Molecular Resonance (QMR) Rehabiltative Treatment of Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-25', 'studyFirstSubmitDate': '2023-01-20', 'studyFirstSubmitQcDate': '2024-01-25', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Kinesiophobia', 'timeFrame': 'T0 - 0 days', 'description': 'Tampa Scale of Kinesiophobia - TSK'}, {'measure': 'Kinesiophobia', 'timeFrame': 'T1 - 1 mounth of treatment', 'description': 'Tampa Scale of Kinesiophobia - TSK'}, {'measure': 'Kinesiophobia', 'timeFrame': 'T2 - 1 mounth after the end of treatment', 'description': 'Tampa Scale of Kinesiophobia - TSK'}], 'primaryOutcomes': [{'measure': 'Knee pain', 'timeFrame': 'T0 - 0 days', 'description': 'Visual Analogue Scale (VAS)'}, {'measure': 'Knee pain', 'timeFrame': 'T1 - 1 mounth of treatment', 'description': 'Visual Analogue Scale (VAS)'}, {'measure': 'Knee pain', 'timeFrame': 'T2 - 1 mounth after the end of treatment', 'description': 'Visual Analogue Scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'Function', 'timeFrame': 'T0 - 0 days', 'description': 'Knee injury and Osteoarthritis Outcome Score (KOOS-I)\n\n\\- Lysholm Knee Scoring Scale'}, {'measure': 'Function', 'timeFrame': 'T1 - 1 mounth of treatment', 'description': 'Knee injury and Osteoarthritis Outcome Score (KOOS-I)\n\n\\- Lysholm Knee Scoring Scale'}, {'measure': 'Function', 'timeFrame': 'T2 - 1 mounth after the end of treatment', 'description': 'Knee injury and Osteoarthritis Outcome Score (KOOS-I)\n\n\\- Lysholm Knee Scoring Scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain', 'physical therapy', 'QMR', 'gonarthrosis', 'synovial fluid', 'monocytes'], 'conditions': ['Knee Pain Chronic']}, 'descriptionModule': {'briefSummary': 'Gonarthrosis (osteoarthritis of the knee (OA) is a chronic-degenerative disease, characterized by progressive joint damage up to disability that affects about 40% of people over 65 years of age. Its typical pathological changes, articular cartilage degradation, synovial inflammation and subchondral bone thickening, are responsible for the pain and disability of patients. It is now known that "biophysical stimulation" techniques represent a non-invasive therapy used in orthopedic practice to enhance the reparative and anabolic activities of the tissues through an anti-inflammatory and chondro-protective effect.The aim of the study will be to evaluate the anti-inflammatory effects and the relative mechanisms of action of the therapeutic interventions of the QMR technology (Molecular Quantum Resonance) in the treatment of gonarthrosis through the use of in vivo and in vitro models. This technology, supplied by Telea Electronic Engineering s.r.l., exploits non-ionizing high-frequency waves in the range between 4 and 64 MHz at low intensity delivered through alternating electric fields. For the in vivo study, a double-blind randomized controlled clinical trial will be conducted. Both male and female subjects, aged between 40 and 80 years, with knee pain both in the acute and chronic phase of gonarthosis, diagnosed on standard radiography, will be enrolled. Patients will be randomized into 2 groups treated with an intensive or extensive protocol, and a third untreated control group. They will be evaluated at T0 (before treatment), at T1 (end of QMR treatment), and at T2 (one month after the end of treatment (follow-up)). All patients will be assessed for pain and functionality, furthermore synovial fluid and blood sampling will be performed, for the quantitative assessment of the inflammatory state considering the levels of the main pro-inflammatory cytokines and the pro/anti-inflammatory macrophage phenotype. In parallel, in order to delineate the molecular and cellular mechanism of action of QMR stimulation in vitro, a monocyte cell model (THP-1 cell line) will be used to evaluate the response of QMR treatment after treatment with known pro-inflammatory stimuli .', 'detailedDescription': 'For the in vivo study, a double-blind randomized controlled clinical trial will be conducted. Both male and female subjects, aged between 40 and 80 years, with knee pain both in the acute and chronic phase of gonarthosis, diagnosed on standard radiography, will be enrolled. Patients will be randomized into 2 groups treated with an intensive or extensive protocol, and a third untreated control group. They will be evaluated at T0 (before treatment), at T1 (end of QMR treatment), and at T2 (one month after the end of treatment (follow-up). All patients will be assessed for pain and functionality, furthermore synovial fluid and blood sampling will be performed, for the quantitative assessment of the inflammatory state considering the levels of the main pro-inflammatory cytokines and the pro/anti-inflammatory macrophage phenotype.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nBoth male and female subjects, aged between 40 and 80 years, with knee pain both in acute and chronic phase due to gonarthosis diagnosed on standard radiography will be enrolled.\n\n* Diagnosis of gonarthrosis with VAS \\>3\n* Presence of acute or chronic pain (the sample will be stratified in one phase next)\n* Radiographic picture of gonarthrosis and staging score according to Kellegren-Lawrence classification (I-II-III)\n\nExclusion Criteria:\n\nfavism, hemolytic anemia\n\n* severe hyperthyroidism - Graves' disease;\n* drug treatment with Tapazole;\n* thrombocytopenia less than 50,000 and serious coagulation disorders;\n* severe cardiovascular instability;\n* coagulation defects;\n* alcohol abuse;\n* hemochromatosis;\n* patients being treated with food-nutraceutical supplements;\n* pregnancy and bed rest;\n* psychiatric pathologies;\n* less than three months from previous knee infiltrations\n* septic arthritis and/or febrile states\n* anamnestic contraindications to the instrumental physical therapy in use (tumor pathologies past)\n\nFurthermore, the following subjects will be excluded from the study:\n\n* with rheumatic and autoimmune diseases\n* patients with recent history of trauma and/or knee (ligament) sprain injuries"}, 'identificationModule': {'nctId': 'NCT06239805', 'acronym': 'QMR', 'briefTitle': 'Quantum Molecular Resonance (QMR) Rehabiltative Treatment of Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': "G. d'Annunzio University"}, 'officialTitle': '"Effectiveness of Molecular Quantum Resonance (QMR) in the Rehabiltative Treatment of Gonarthrosis"', 'orgStudyIdInfo': {'id': "Ud'A Chieti-Pescara"}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental intensive group', 'description': 'Experimental: intensive treatment', 'interventionNames': ['Device: QMR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control extensive group', 'description': 'extensive treatment', 'interventionNames': ['Device: QMR']}, {'type': 'SHAM_COMPARATOR', 'label': 'control sham group', 'description': 'sham group', 'interventionNames': ['Device: QMR']}], 'interventions': [{'name': 'QMR', 'type': 'DEVICE', 'description': 'A: Treated group (active medical device): intensive protocol B: Treated Group (active medical device): extensive protocol C: Sham/Control group (medical device off)\n\nPatients will be treated as follows:\n\nA- Treated Group: three sessions a week, for a total of 6 sessions, with one session lasting of 30 minutes. The session involves the application of electrodes (adhesive plates), and Q- glove Touch (frequency/intensity)\n\nB- Treated Group: two sessions a week, for a total of 8 sessions, lasting a 20 minute session. The session involves the application of electrodes (adhesive plates), e Q-Touch glove (frequency/intensity)\n\nC- Control/Sham group: three sessions a week, for a total of 6 sessions, lasting a 30 minute session. The session involves the application of electrodes (adhesive plates), e Q-Touch glove with device off.', 'armGroupLabels': ['Control extensive group', 'Experimental intensive group', 'control sham group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65128', 'city': 'Pescara', 'state': 'PE', 'country': 'Italy', 'facility': 'Don Orione Foundation', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}], 'overallOfficials': [{'name': 'Antonia Patruno, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University G. d'Annunzio Chieti Pescara"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It is not yet known if there will be a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "G. d'Annunzio University", 'class': 'OTHER'}, 'collaborators': [{'name': 'Teresa Paolucci', 'class': 'UNKNOWN'}, {'name': 'Mirko Pesce', 'class': 'UNKNOWN'}, {'name': 'Roberto Buda', 'class': 'UNKNOWN'}, {'name': 'Andrea Pantalone', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Antonia Patruno', 'investigatorAffiliation': "G. d'Annunzio University"}}}}