[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616658":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":35,"studyPopulation":24,"armGroups":36,"interventions":48,"overallOfficials":24,"centralContacts":56,"locations":66,"responsibleParty":79,"collaborators":24,"id":83,"slug":24,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":24,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":24,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":104,"whyStopped":24,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Pharos University in Alexandria","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Pain Severity","Pain severity in patients with knee osteoarthritis measured using the Visual Analog Scale (VAS)Units on a 0-10 scale","Baseline, 4 weeks, 8 week",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Functional Improvement","Improvement in knee function assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale-Units on a 0-68 scale","Baseline, 4 weeks, 8 weeks",{"measure":19,"description":20,"timeFrame":17},"Patient Global Assessment of Disease Activity","Patient's overall assessment of their osteoarthritis symptoms measured using a 0-100 scaleوUnits on a 0-100 scale",{"measure":22,"description":23,"timeFrame":17},"Physician's Global Assessmen","Physician's assessment of the patient's overall osteoarthritis status using a standardized scale-Units on a 0-100 scale",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":28,"primaryPurpose":29,"observationalModel":24,"timePerspective":24,"maskingInfo":30},"RANDOMIZED","PARALLEL","This is a randomized, parallel-assignment, single-blind interventional study. Thirty patients with mild to moderate unilateral knee osteoarthritis will be randomly assigned to either a control group receiving traditional physiotherapy or an experimental group receiving physiotherapy plus topical Etodolac-loaded nanoparticle gel. Outcome measures will be assessed at baseline and after 4 weeks to evaluate pain, knee function, functional performance, quadriceps strength, and proprioception","TREATMENT",{"masking":31,"maskingDescription":32,"whoMasked":33},"SINGLE","In this single-blind study, the outcome assessor is blinded to group allocation to minimize measurement bias. Participants and physiotherapists are aware of the treatment they receive, but all assessments of pain, knee function, functional performance, quadriceps strength, and proprioception are conducted by a blinded assessor.",[34],"OUTCOMES_ASSESSOR","This randomized clinical trial investigates the effect of adding a topical Etodolac-loaded solid lipid nanoparticle gel to traditional physiotherapy in patients with mild to moderate unilateral knee osteoarthritis (OA). Thirty patients aged 45-60 years will be randomly assigned to either physiotherapy alone (control) or physiotherapy plus Etodolac nanogel (experimental) for 4 weeks. Outcomes include pain (VAS), knee function (WOMAC), functional performance (TUG, 2MWT), quadriceps strength, and proprioception. The study aims to determine whether the combination therapy provides superior pain relief, improved joint function, and enhanced muscle performance compared with physiotherapy alone, while potentially reducing systemic NSAID exposure",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Traditional Physiotherapy + Etodolac-Loaded Nanoparticle Gel","EXPERIMENTAL","Participants will receive the same structured physiotherapy program as the control group, in addition to topical application of Etodolac-loaded solid lipid nanoparticle gel on the affected knee.\n\nPhysiotherapy components:\n\nQuadriceps strengthening exercises\n\nLower limb muscle conditioning\n\nAerobic walking program\n\nFunctional mobility exercises\n\nEtodolac nanogel application: Applied topically according to the study protocol to provide localized analgesic and anti-inflammatory effects.\n\nDuration: 4 weeks, with standardized physiotherapy sessions and daily topical gel application.\n\nPurpose: To evaluate whether adding Etodolac-loaded nanoparticle gel enhances pain relief, knee function, functional performance, quadriceps strength, and proprioception compared with physiotherapy alone",[42],"Combination Product: Etodolac-Loaded Solid Lipid Nanoparticle Gel",{"label":44,"type":45,"description":46,"interventionNames":47},"Traditional Physiotherapy Exercises","ACTIVE_COMPARATOR","Participants will receive a structured physiotherapy program for knee osteoarthritis, which includes:\n\nQuadriceps strengthening exercises\n\nLower limb muscle conditioning\n\nAerobic walking program\n\nFunctional mobility exercises\n\nDuration: 4 weeks, following standardized procedures for all participants. Purpose: To serve as the control group for comparison with the experimental group receiving additional Etodolac-loaded nanoparticle gel",[42],[49],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"COMBINATION_PRODUCT","Etodolac-Loaded Solid Lipid Nanoparticle Gel","Physiotherapy program includes:\n\nQuadriceps strengthening exercises\n\nLower limb muscle conditioning\n\nAerobic walking program\n\nFunctional mobility exercises",[38,44],[55],"Traditional Aerobic Training",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":24,"email":61},"Yosra Elnagar, proffesor","CONTACT","01277629944","yosra.elnaggar@pua.edu.eg",{"name":63,"role":59,"phone":64,"phoneExt":24,"email":65},"ola elgohary, lecturer","01227191398","ola.elgohary@pua.edu.eg",[67],{"facility":68,"status":24,"city":69,"state":24,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":24},"Pharos University-Faculty of Physical Therapy","Alexandria","21614","Egypt","EG",{"type":74,"coordinates":75},"Point",[76,77],29.91582,31.20176,{"lat":77,"lon":76},{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Ola Mohamed Elsayed Elgohary","Lecturer, Department of Physical Therapy for cardiopulmonary , Pharos University","100616658",false,"NCT07308470","Etodolac Nanogel as an Adjunct to Physiotherapy for Knee Osteoarthritis","Effect of Etodolac-Loaded Solid Lipid Nanoparticle Gel as an Adjunct to Physiotherapy in Knee Osteoarthritis: A Randomized Clinical Tria","Inclusion Criteria:\n\n* Age between 45 and 60 years.\n\nMild to moderate unilateral knee osteoarthritis (Kellgren-Lawrence grades II-III).\n\nAbility to walk independently without assistive devices.\n\nBody Mass Index (BMI) \\\u003C 30 kg\u002Fm².\n\nNo participation in resistance training in the 3 months prior to enrollment.\n\nReferred by an orthopedic surgeon and diagnosed based on clinical and radiological examination.\n\nExclusion Criteria:\n\n* Severe or bilateral knee osteoarthritis (Kellgren-Lawrence grade IV).\n\nCongenital or acquired inflammatory, rheumatic, or neurological disorders affecting the knee.\n\nRepeated treatment with steroids or secondary knee OA.\n\nHistory of joint replacement surgery in the knee or hip.\n\nCardiovascular or neuromuscular disorders.\n\nDiabetes mellitus.\n\nPsychiatric disorders.",true,"ALL","45 Years","60 Years",{"count":94,"type":95},30,"ESTIMATED","INTERVENTIONAL",[98],"PHASE2","Brief Summary:\n\nKnee osteoarthritis (OA) is a common, disabling condition affecting the weight-bearing knee joint, leading to pain, reduced function, and muscle weakness, particularly of the quadriceps. Strengthening exercises are recommended to improve joint stability, physical function, and slow disease progression. Etodolac, a selective NSAID approved for osteoarthritis, has proven analgesic and anti-inflammatory effects. This study investigates the adjunctive effect of a topical Etodolac-loaded solid lipid nanoparticle gel combined with traditional physiotherapy in patients with knee OA. Thirty patients with mild to moderate unilateral tibiofemoral OA will be randomized into two groups: traditional physiotherapy alone or physiotherapy plus Etodolac gel. Outcomes including pain, knee function, functional performance, quadriceps strength, and proprioception will be assessed at baseline and after four weeks. The study aims to determine whether adding topical Etodolac enhances the benefits of standard physiotherapy in managing knee OA.",[101],"Knee Osteoarthritis",[103],"osteoarthritis-Etodolac","NOT_YET_RECRUITING","2025-12-19",{"date":107,"type":108},"2025-12-29","ACTUAL",{"date":110,"type":95},"2026-01-08",{"date":112,"type":95},"2026-03-07",{"name":5,"class":6},1]