[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632606":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":41,"locations":47,"responsibleParty":78,"collaborators":31,"id":80,"slug":31,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":31,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":31,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":105,"whyStopped":31,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"ZetrOZ, Inc.","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"SAM Ultrasound Device and Diclofenac Patch","EXPERIMENTAL","Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 12 weeks combined with 2.5% diclofenac patch. The SAM Device emits continuous ultrasound at 3 megahertz(MHz) frequency and 0.132 watts\u002Fcm\\^2 intensity.",[13],"Device: Sustained Acoustic Device with 2.5% Diclofenac Patch",{"label":15,"type":16,"description":17,"interventionNames":18},"SAM Ultrasound Device and SAM Patch","ACTIVE_COMPARATOR","Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 12 weeks combined with SAM patch (0% diclofenac).",[19],"Device: Sustained Acoustic Device with 0% Diclofenac Patch",{"label":21,"type":16,"description":22,"interventionNames":23},"Corticosteroid Injection","Patients receive treatment of single intraarticular corticosteroid injection (triamcinolone acetonide)",[24],"Drug: Intra articular injection",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Sustained Acoustic Device with 2.5% Diclofenac Patch","Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts\u002Fcm\\^2 with 2.5% Diclofenac patches.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Sustained Acoustic Device with 0% Diclofenac Patch","Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches.",[15],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"DRUG","Intra articular injection","Single intraarticular injection of 1cc 40mg\u002Fcc triamcinolone acetonide",[21],[42],{"name":43,"role":44,"phone":45,"phoneExt":31,"email":46},"Ralph Ortiz, DO, MPH","CONTACT","607-844-9979","drortizmpc@gmail.com",[48,66],{"facility":49,"status":31,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Orthopaedic Foundation","Stamford","Connecticut","06905","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-73.53873,41.05343,{"lat":59,"lon":58},[62],{"name":63,"role":44,"phone":64,"phoneExt":31,"email":65},"Stephanie Petterson, PhD, MPT","203-869-2002","spetterson@ofals.org",{"facility":67,"status":31,"city":68,"state":69,"zip":70,"country":53,"countryCode":54,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Cayuga Medical Center - Medical Pain Consultants","Dryden","New York","13053",{"type":56,"coordinates":72},[73,74],-76.29716,42.49091,{"lat":74,"lon":73},[77],{"name":43,"role":44,"phone":45,"phoneExt":31,"email":46},{"type":79,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100632606",false,"NCT07515872","Long Duration High Frequency Ultrasound for the Treatment of Osteoarthritis","Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis","Inclusion Criteria:\n\n* Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2)\n* Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA\n* Are between 65-85 years of age\n* Report a frequent pain score between 4-7 (range: 0-10) during the week preceding enrollment\n* Report that knee pain negatively affects quality of life\n* Are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided to the subject at the initiation of the study\n* Are deemed appropriate by their physician or by the study site physician to participate.\n* Be willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device.\n* Not use or initiate use of opioid and\u002For non-opioid analgesic medications.\n* Be willing to discontinue any other interventional treatment modalities on the knee during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).\n\nExclusion Criteria:\n\n* Cannot successfully demonstrate the ability to put on and take off the device.\n* Displays any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to, the subject's ability to understand and follow instructions.\n* Participated in a clinical trial for an investigational drug and\u002For agent within 30 days prior to screening.\n* Is pregnant.\n* Is a prisoner.\n* Is non-ambulatory (unable to walk).\n* Has a pacemaker.\n* Has a malignancy in the treatment area.\n* Has an active infection, open sores, or wounds in the treatment area.\n* Has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia.\n* Has a known neuropathy (disease of the brain or spinal nerves).\n* Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage).\n* Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months.\n* Are currently taking steroids.\n* Have any contraindication to radiograph.\n* Have a secondary cause of arthritis (metabolic or inflammatory).\n* Have a known contraindication, allergy, or hypersensitivity to corticosteroids or any component of Kenalog®-40 (if assigned to the injection group).",true,"ALL","65 Years","85 Years",{"count":91,"type":92},240,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","The purpose of this study is to assess the ability of long-duration high-frequency continuous-wave therapeutic ultrasound to alleviate knee Osteoarthritis pain over an 12-week period. The primary objective of this study is to evaluate the analgesic effect of ultrasound treatment in subjects suffering from knee Osteoarthritis pain. Secondary objectives are to assess the ability of ultrasound treatment to improve joint function.",[98,99],"Arthritis","Osteo Arthritis of the Knee",[101,102,103,104],"high-frequency continuous ultrasound","sustained acoustic medicine","low-intensity continuous ultrasound","wearable long duration ultrasound","NOT_YET_RECRUITING","2026-03-31",{"date":108,"type":109},"2026-04-07","ACTUAL",{"date":111,"type":92},"2026-05-01",{"date":113,"type":92},"2028-05-31",{"name":5,"class":6},2]