Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT00832312
Status:
TERMINATED
Last Update Posted:
2016-07-28
First Post:
2009-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Because of technical problems (researcher moved to different city).', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-27', 'studyFirstSubmitDate': '2009-01-29', 'studyFirstSubmitQcDate': '2009-01-29', 'lastUpdatePostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain control', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Knee', 'Pain management', 'Ozone therapy', 'Intraarticular injection'], 'conditions': ['Osteoarthritis of the Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether an intraarticular injection of Ozone into the knee joint is an effective therapy for pain control in patients with osteoarthritis of the knee.', 'detailedDescription': 'Ozone, as a gas made of three atoms of oxygen with a cyclic structure, has been used as a medical therapy from the mid ninetieth century. Today, this therapy is a recognized modality in many European and Latin American nations for orthopedic problems, infections, ischemic diseases, and skin problems. However, despite of this wide use internationally, there is minimal mention of this treatment modality in the Anglo-American literature.\n\nThe present is the first of a series of studies planned to scientifically test the effectiveness of ozone as a main-stream therapy, introducing it to the Anglo-American literature. In this first study we will check whether intraarticular injections of Ozone into the knee joint are effective as a therapy for pain control in patients with osteoarthritis of the knee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Osteoarthritis of knee\n\nExclusion Criteria:\n\n* Positive rheumatologic serologic tests\n* Cognitive impairment\n* Adjacent osteomyelitis\n* Bacteremia\n* Hemarthrosis\n* Impending (scheduled within days) joint replacement surgery\n* Infectious arthritis\n* Joint prosthesis\n* Osteochondral fracture\n* Periarticular cellulitis\n* Poorly controlled diabetes mellitus\n* Uncontrolled bleeding disorder or coagulopathy.'}, 'identificationModule': {'nctId': 'NCT00832312', 'briefTitle': 'Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee', 'organization': {'class': 'OTHER', 'fullName': 'Ben-Gurion University of the Negev'}, 'officialTitle': 'Intraarticular Ozone Therapy for Pain Control in Osteoarthritis of the Knee', 'orgStudyIdInfo': {'id': '20080780'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ozone-oxygen mixture', 'description': '10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml) injected into the knee joint', 'interventionNames': ['Other: ozone-oxygen mixture']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Injection of 1cc of saline into the knee joint', 'interventionNames': ['Other: placebo (saline)']}], 'interventions': [{'name': 'ozone-oxygen mixture', 'type': 'OTHER', 'description': '10 cc of an ozone-oxygen mixture with ozone concentration 10000 mcg/L (10 mcg/ml)', 'armGroupLabels': ['ozone-oxygen mixture']}, {'name': 'placebo (saline)', 'type': 'OTHER', 'description': 'Injection of 1cc of saline into the knee joint', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84105', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Ben Gurion University', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'overallOfficials': [{'name': 'Howard B Tandeter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ben GurionUniversity'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ben-Gurion University of the Negev', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'POB 653 Beer Sheva', 'investigatorFullName': 'Howard Tandeter', 'investigatorAffiliation': 'Ben-Gurion University of the Negev'}}}}