Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-30 @ 11:22 PM
Study NCT ID:
NCT06774469
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-14
First Post:
2024-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Overdose Ultrasound on Osteoarthritic Knee in Adult Albino Rat: a Histological Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '40 rats'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-03-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-11', 'studyFirstSubmitDate': '2024-12-24', 'studyFirstSubmitQcDate': '2025-01-11', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Samples to estimate the knee cartilage thickness (femoral cartilage)', 'timeFrame': 'at the begginig of the experiment and at the end', 'description': 'captured by a microscope camera and analyzed using the Image J software (https://imagej.en.softonic.com) .'}, {'measure': 'Samples to detect the morphology and the histological changes in cartilage matrix', 'timeFrame': 'at the begginig of the experiment and at the end', 'description': 'Matrix changes can be detected by using different histochemical stains as a trichrome stain for the demonstration of collagen fibers and a combination of Van Gieson and Safranin O stains'}, {'measure': 'Cellular changes', 'timeFrame': 'at the begginig of the experiment and at the end', 'description': 'by studying and analyzing the hematoxylin and eosin stained section by using different lens powers of microscope.'}, {'measure': 'Inflammatory changes', 'timeFrame': 'at the begginig of the experiment and at the end', 'description': 'by immunohistochemical stains of CD markers according to the availability (either INOS or NF-KB).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Osteoarthritis-ultrasound-overdose-albino rats-MIA-Articular cartilage'], 'conditions': ['Osteoarthritis of Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of overdose ultrasound on the articular cartilage of the osteoarthritic knee in adult albino rate. The US is considered the most popular and effective treatment for osteoarthritis as it can penetrate deep tissue reaching internal structures which allow it to be effective for osteoarthritis treatment. Previous researches apply US as a treatment for different cases with different intensity and repetition, but no one has actually proven the frequency of this use or the effect of excess use on cells, so the investigators need evidence to determine the optimum therapeutic dose and frequent repetition which should determine the effect of more than one session on the joint cartilage and cells and if it has a positive or negative effect and this is the main goal in this study which is limited in all studies concerning the US.', 'detailedDescription': "Because many patients suffer from osteoarthritis and this work may help for treatment those patients. The US is considered the most popular and effective treatment for osteoarthritis as it can penetrate deep tissue reaching internal structures which allow to be effective for osteoarthritis treatment, also improves the cellular function by making microscopic gas bubbles near to the site of injury expand and contract rapidly, a process called cavitation. This process is thought to speed up the healing process in the injured body part. Previous researches apply US as a treatment for different cases with different intensity and repetition, but no one has actually proven the frequency of this use or the effect of excess use on cells, so the investigators need evidence to determine the optimum therapeutic dose and frequent repetition which should determine the effect of this repetition on the joints and cells and if has a positive or negative effect and this is the main goal in this study which is limited in all studies concerning the US in addition to previous systematic reviews regarding its effectiveness on KOA are outdated, and the latest reviews presented methodological limitations, such as the inclusion of mixed interventions, that hindered the evidence synthesis, and the inclusion of pulsed US (low-intensity) only.\n\nThe Investigators want to perform a more focused and comprehensive evidence synthesis targeting the isolated effects of the therapeutic US and specially the overdose to more clearly define its contributing role as an adjuvant treatment in rehabilitative regimens for KOA. Therefore studies worked on the effect of ultrasound on the knee cartilage especially femoral cartilage, the degradation and destruction of the femoral articular cartilage demonstrated a greater degree of deterioration than those of the tibial and patellar articular cartilage, and on some specific changes within its cells like apoptosis neglecting other cellular or matrix changes which may be affected by the destruction of articular cartilage and it's the second aim in this study. Although the results of previous studies suggest that US is a safe non-pharmacological treatment option that may provide additional pain relief and functional improvement in addition to cartilage repair with different parameters of US, no research assessing dosing regimen repetition to investigate its overdose effect on tissues and this was not reasonable to perform these analyses based on overdose on humans. This is the topic for the research, because the optimum therapeutic dose of therapeutic US is debated in previous research."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '8 Weeks', 'minimumAge': '7 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Forty male Albino rats will be used for the study of knee osteoarthritis.\n* At 7-8 weeks of age.\n* 200-250 grams in weight will be obtained from the animal facility of the histology department, Faculty of Medicine, Tanta University.\n\nExclusion Criteria:\n\n* Weight \\< 200-250 \\> kg.\n* Rats with injured thighs and/or knees.\n* Female rats.'}, 'identificationModule': {'nctId': 'NCT06774469', 'briefTitle': 'Effect of Overdose Ultrasound on Osteoarthritic Knee in Adult Albino Rat: a Histological Study', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Overdose Ultrasound on the Articular Cartilage of the Osteoarthritic Knee in Adult Albino Rat: a Histological Study', 'orgStudyIdInfo': {'id': 'cu III F 89 23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'G1 (Control group)', 'description': '(Normal group) For studying the normal histological structure of the articular knee joint. Will be assessed at the beginning of the study', 'interventionNames': ['Device: ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'G2 expermintal', 'description': '(Normal-US Group) Will be assessed after 30 consequent days', 'interventionNames': ['Device: assigned']}, {'type': 'EXPERIMENTAL', 'label': 'G3 expermintal', 'description': '(Osteoarthritis-induced group)Will be assessed after 14 days', 'interventionNames': ['Drug: Injection, Solution']}, {'type': 'EXPERIMENTAL', 'label': 'G4 expermintal', 'description': '(Osteoarthritis-Recovery group): Will be assessed after44 days', 'interventionNames': ['Drug: Injection, Solution']}, {'type': 'EXPERIMENTAL', 'label': 'G5 experimental', 'description': '(Osteoarthritis-US group) Will be assessed after 44 days', 'interventionNames': ['Device: assigned']}], 'interventions': [{'name': 'assigned', 'type': 'DEVICE', 'description': 'Group II: (Normal-US Group): The rats will receive 2 sessions/ day of underwater pulsed US waves with 1 MHZ frequency and 1 watt/cm2 power, for 10 min for 30 consequent days applied to the right knee. The rats will be sacrificed after 30 days. Group V: (Osteoarthritis-US group) after two weeks of chemical induction of osteoarthritis, the rats will receive 2 sessions/ day of underwater pulsed US waves with 1 MHZ frequency and 1 watt/cm2 power for 10 min for 30 consequent days applied to the right knee. The rats will be sacrificed after 44 days.', 'armGroupLabels': ['G2 expermintal', 'G5 experimental']}, {'name': 'Injection, Solution', 'type': 'DRUG', 'otherNames': ['MIA induction'], 'description': 'Group III: (Osteoarthritis-induced group): For studying the histological changes of the articular knee joint after osteoarthritis induction in the right knee joint before recovery occur. The patellar ligament will be palpated below the patella and a single intra-articular injection of (MIA lateral to the ligament using an insulin syringe will be performed).\n\nThe rats will be injected once with monosodium iodoacetate (MIA) dissolved in sterile saline (6 mg/kg body weight, 50 μL). Saline acts as a vehicle for MIA. The rats will be sacrificed after 14 days of MIA injection (1st day of the experiment).\n\nGroup IV: (Osteoarthritis-Recovery group): The rats will be injected once with monosodium iodoacetate (MIA) dissolved in sterile saline (6 mg/kg body weight, 50 μL), Saline acts as a vehicle for MIA and will not receive any medication. The rats will be sacrificed after 44 days of MIA injection (1st day of the experiment).', 'armGroupLabels': ['G3 expermintal', 'G4 expermintal']}, {'name': 'ultrasound', 'type': 'DEVICE', 'description': 'Group I:Sham Comparator (Control group): for studying the normal histological structure of the articular knee joint.', 'armGroupLabels': ['G1 (Control group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Physical Therapy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Shereen Shawky Elabd, Assis. prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanta University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'physiotherapist specialist', 'investigatorFullName': 'Shahenda Mohamed Eissa', 'investigatorAffiliation': 'Cairo University'}}}}