[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645047":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":41,"centralContacts":42,"locations":48,"responsibleParty":69,"collaborators":41,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":41,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":41,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":50,"whyStopped":41,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Kayseri City Hospital","OTHER_GOV",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"10 µg Ozone + Exercise","EXPERIMENTAL","10 mL of ozone injection at a concentration of 10 µg\u002FmL + Home exercise program",[13,14],"Other: ozone injection","Behavioral: Exercise",{"label":16,"type":10,"description":17,"interventionNames":18},"15 µg Ozone + Exercise","10 mL of ozone injection at a concentration of 15 µg\u002FmL + Home exercise program",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"20 µg Ozone + Exercise","10 mL of ozone injection at a concentration of 20 µg\u002FmL + Home exercise program",[13,14],{"label":24,"type":25,"description":26,"interventionNames":27},"Exercise Alone","ACTIVE_COMPARATOR","Home exercise program alone",[14],[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"OTHER","ozone injection","All patients allocated to the ozone intervention groups will receive a total of 3 sessions of intra-articular ozone injections, administered once a week for three consecutive weeks. For all three treatment groups, the injection volume will be 10 mL per session, while the ozone concentrations will vary according to the assigned group as Ozone 10 µg\u002FmL + Exercise, Ozone 15 µg\u002FmL + Exercise, and Ozone 20 µg\u002FmL + Exercise.",[9,16,20],[35],"Intra-articular Ozone Injection",{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"BEHAVIORAL","Exercise","All participants across all four groups will be prescribed a structured home exercise program. This program includes joint range of motion (ROM) exercises; strengthening exercises (including quadriceps strengthening, hamstring strengthening, hip abductor strengthening, and seated calf raises); and flexibility exercises (including hamstring stretching, gastrocnemius-soleus stretching, and quadriceps stretching).\n\nThe home program will be performed for 30 minutes per day, 5 days a week, throughout the 3-month study period. To improve patient adherence to exercise, patients will be provided with an exercise diary.",[9,16,20,24],null,[43],{"name":44,"role":45,"phone":46,"phoneExt":41,"email":47},"Serhat Efdal Ozbek, MD","CONTACT","+905072387257","serhatefdal60@gmail.com",[49],{"facility":5,"status":50,"city":51,"state":41,"zip":52,"country":53,"countryCode":41,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Kayseri","38080","Turkey (Türkiye)",{"type":55,"coordinates":56},"Point",[57,58],35.48528,38.73222,{"lat":58,"lon":57},[61,62,64,67],{"name":44,"role":45,"phone":46,"phoneExt":41,"email":47},{"name":44,"role":63,"phone":41,"phoneExt":41,"email":41},"SUB_INVESTIGATOR",{"name":65,"role":66,"phone":41,"phoneExt":41,"email":41},"Fatma Gul Ulku Demir, MD","PRINCIPAL_INVESTIGATOR",{"name":68,"role":63,"phone":41,"phoneExt":41,"email":41},"Havva Talay Calis, Professor",{"type":66,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Fatma Gül Ülkü Demir","MD, Department of Physical Medicine and Rehabilitation","100645047","dose-response-effect-of-intra-articular-ozone-in-knee-osteoarthritis-100645047",false,"NCT07678996","Dose-Response Effect of Intra-Articular Ozone in Knee Osteoarthritis","Dose-Response Effect of Intra-Articular Ozone in Knee Osteoarthritis: A Randomized Controlled Single-Blind Clinical Study","Inclusion Criteria:\n\n* Patients aged 40-75 years diagnosed with knee osteoarthritis according to the American College of Rheumatology 2019 criteria\n* Grade 2 or 3 knee osteoarthritis based on the Kellgren-Lawrence radiological classification system.\n* Presence of chronic knee pain lasting for more than 6 months.\n* Numerical Rating Scale score of 3 or higher during knee-loading activities\n\nExclusion Criteria:\n\n* Presence or history of acute knee infection, major knee trauma, or inflammatory arthritis\n* History of knee fracture or surgical intervention involving the affected knee joint within the last 6 months.\n* History of intra-articular injections (e.g., corticosteroids, hyaluronic acid, PRP) into the affected knee joint within the last 6 months.\n* History of physical therapy or rehabilitation in the knee region within the last 6 months\n* Presence of osteomyelitis adjacent to the knee joint, bacteremia, or hemarthrosis.\n* History of malignancy involving the lower extremity.\n* Known hypersensitivity or allergy to medical ozone.\n* Severe anemia, thrombocytopenia, active bleeding disorders, or ongoing anticoagulant therapy.\n* Pregnancy or lactation\n* Active infection\n* Severe systemic diseases (e.g., advanced cardiopulmonary disease, uncontrolled diabetes mellitus).\n* Hyperthyroidism or progressive neuromuscular disorders.\n* Cognitive impairment or inability to cooperate with the assessment tools and study protocol.","ALL","40 Years","75 Years",{"count":83,"type":84},80,"ESTIMATED","INTERVENTIONAL",[87],"NA","The goal of this clinical trial is to evaluate the clinical efficacy of different doses of intra-articular ozone injections combined with exercise in patients aged 40-75 diagnosed with Grade 2-3 knee osteoarthritis.\n\nThe main questions it aims to answer are:\n\n* Which intra-articular ozone doses (10 µg\u002FmL, 15 µg\u002FmL, or 20 µg\u002FmL) is most effective in improving pain and physical function in knee osteoarthritis?\n* Do combined ozone and exercise therapies provide superior clinical outcomes compared to exercise therapy alone? Researchers will compare four groups (Ozone 10 µg\u002FmL + Exercise, Ozone 15 µg\u002FmL + Exercise, Ozone 20 µg\u002FmL + Exercise and Exercise Alone) to see the dose-dependent effects of ozone therapy.\n\nParticipants will:\n\n* Complete a structured home exercise program for the duration of the study.\n* Receive 3 sessions of intra-articular ozone injections (for patients allocated to the ozone groups).\n* Participate follow-up visits for clinical and functional assessments at baseline (before the procedure), immediately after the 3rd injection session, at 1 month after the last ozone injection, and at 3 months after the last ozone injection.",[90],"Knee Osteoarthritis",[92,93,94],"osteoarthritis","ozone","knee","2026-06-30",{"date":97,"type":98},"2026-07-01","ACTUAL",{"date":100,"type":98},"2025-11-19",{"date":102,"type":84},"2026-11-30",{"name":5,"class":6},1]