Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-31 @ 8:50 PM
Study NCT ID:
NCT06909305
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2025-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intraarticular Ozone, Prolotherapy or Dexmedetomidine in Pain Limitation in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010126', 'term': 'Ozone'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D010100', 'term': 'Oxygen'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2025-03-27', 'studyFirstSubmitQcDate': '2025-03-27', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesic requirement', 'timeFrame': '3 months after the procedure', 'description': 'Analgesic requirements for pain control after injection were recorded.'}], 'secondaryOutcomes': [{'measure': 'Improvement of lifestyle', 'timeFrame': '3 months after the procedure', 'description': "Improvement of lifestyle was assessed using the Western Ontario Mac Master Osteoarthritis Index (WOMAC-OI) scale. The Likert type of the WOMAC Persian version was employed in this paper. The Persian version is a dependable and uncomplicated procedure that provides five responses: extreme (4), severe (3), moderate (2), mild (1), and none (0). The patients' stiffness, pain, and functional restriction are all represented by the higher scores."}, {'measure': 'Improvement of knee joint cartilage regeneration', 'timeFrame': '3 months after the procedure', 'description': 'Improvement of knee joint cartilage regeneration was assessed using the Kellgren-Lawrence Classification System (K-L). K-L: which categorize knee OA into four stages based on radiological findings: Grade 4 (severe): Marked joint space narrowing, large osteophytes, severe sclerosis, and definite deformity of bone ends. Grade 3 (moderate): Moderate multiple osteophytes, some sclerosis, definite joint space narrowing, and potential deformity of bone ends. Grade 2 (minimal): Definite osteophytes and potential joint space narrowing. Grade 1 (doubtful): Possible osteophytic lipping and doubtful joint space narrowing.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraarticular', 'Ozone', 'Prolotherapy', 'Dexmedetomidine', 'Pain', 'Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study aimed to compare intraarticular ozone injection, prolotherapy, or dexmedetomidine effectiveness in knee osteoarthritis patients.', 'detailedDescription': 'Osteoarthritis (OA) is a heterogeneous group of disorders of different etiologies with similar biological, morphological, and clinical manifestations and outcomes. The intraarticular injection has been recommended to alleviate the pain in the knee joint.\n\nOzone therapy has long been used in the management of OA. Furthermore, it has been shown to not cause a significant inflammation process or cartilage degradation. Prolotherapy is a procedure where a natural irritant is injected into the soft tissue of an injured joint. Dexmedetomidine is a selective α2-adrenergic agonist with considerable sedative and analgesic actions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 30 to 65 years.\n* Both genders.\n* Patients diagnosed with stage 1-3 osteoarthritis according to the Kellgren-Lawrence Classification System (K-L).\n\nExclusion Criteria:\n\n* Patient refusal.\n* History of knee trauma within the past month.\n* Rheumatic disease.\n* Pregnancy.\n* Any surgical intervention of the knee.\n* Severe cardiovascular disease.\n* Morbid obese patients (body mass index (BMI) of \\>35 kg/m2).\n* Local infection at the site of injection.\n* Bleeding diathesis.'}, 'identificationModule': {'nctId': 'NCT06909305', 'briefTitle': 'Effect of Intraarticular Ozone, Prolotherapy or Dexmedetomidine in Pain Limitation in Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Effect of Intraarticular Ozone, Prolotherapy or Dexmedetomidine in Pain Limitation in Knee Osteoarthritis: A Randomized Prospective Study', 'orgStudyIdInfo': {'id': '35148/12/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ozone group', 'description': 'Patients received intraarticular ozone injection.', 'interventionNames': ['Drug: Ozone']}, {'type': 'EXPERIMENTAL', 'label': 'Dextrose prolotherapy group', 'description': 'Patients received intraarticular dextrose prolotherapy injection.', 'interventionNames': ['Drug: Dextrose prolotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine group', 'description': 'Patients received intraarticular dexmedetomidine injection.', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Ozone', 'type': 'DRUG', 'description': 'Patients received intraarticular ozone injection.', 'armGroupLabels': ['Ozone group']}, {'name': 'Dextrose prolotherapy', 'type': 'DRUG', 'description': 'Patients received intraarticular dextrose prolotherapy injection.', 'armGroupLabels': ['Dextrose prolotherapy group']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Patients received intraarticular dexmedetomidine injection.', 'armGroupLabels': ['Dexmedetomidine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management, Faculty of Medicine, Tanta University, Tanta, Egypt', 'investigatorFullName': 'Ghada Abd El-Wahab Saif El-Dien', 'investigatorAffiliation': 'Tanta University'}}}}