[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07515872":3,"trial-entities:NCT07515872":138,"trial-summary:NCT07515872":142},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":51,"secondary_outcomes":60,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":99,"locations":101,"central_contacts":130,"overall_officials":132,"references":133,"see_also_links":134},"NCT07515872","KP-01-2026","Long Duration High Frequency Ultrasound for the Treatment of Osteoarthritis","Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis","NOT_YET_RECRUITING","2028-05-31","2026-03","2026-04-07","2026-05-01","ZetrOZ, Inc.","INDUSTRY",null,"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.","This is an 12-week study to clinically evaluate the effectiveness of the Sustained Acoustic Medicine (SAM) device combined with diclofenac on symptoms of patients suffering from knee osteoarthritis. The class-II device, sam®, has been FDA-cleared for home use. On the first day of the study, baseline data will be collected as patients report pain score before treatment. During the following 12 weeks, patients will self-apply their assigned treatment for the 4 hours daily. Each day of the study, pain scores will be recorded immediately before application of SAM device as well as at the completion of treatment. A quality of life and function assessment will be performed prior to the patient beginning the protocol and at the conclusion of the protocol.",[19,20],"Arthritis","Osteo Arthritis of the Knee",[22,23,24,25],"high-frequency continuous ultrasound","sustained acoustic medicine","low-intensity continuous ultrasound","wearable long duration ultrasound","INTERVENTIONAL","TREATMENT",[29],"PHASE2",{"count":31,"type":32},240,"ESTIMATED",[34,40,45],{"type":35,"name":36,"description":37,"armGroupLabels":38},"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.",[39],"SAM Ultrasound Device and Diclofenac Patch",{"type":35,"name":41,"description":42,"armGroupLabels":43},"Sustained Acoustic Device with 0% Diclofenac Patch","Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches.",[44],"SAM Ultrasound Device and SAM Patch",{"type":46,"name":47,"description":48,"armGroupLabels":49},"DRUG","Intra articular injection","Single intraarticular injection of 1cc 40mg\u002Fcc triamcinolone acetonide",[50],"Corticosteroid Injection",[52,56],{"measure":53,"description":54,"timeFrame":55},"Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline","Change in the self-described pain units on a scale by patient at baseline and post-treatment","Through study completion, average of 12 weeks",{"measure":57,"description":58,"timeFrame":59},"Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)","WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in scores. WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0 - 4, 0 being no pain 4 is worst pain possible, for a range of 0 - 20 points. The stiffness category consists of two scores from 0 - 4, 0 being no stiffness 10 is worst stiffness possible for a range of 0 - 8 points. The function score consists of 17 scores from 0 - 4, 0 being normal function and 10 is severely limited function, for a range of 0 - 68 points. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96).","Through study completion, average of 12 weeks.",[61],{"measure":62,"description":63,"timeFrame":59},"Change in Global Rating of Change (GROC) on a Scale (-7 to +7)","Subject-reported rating of impact of pain on sleep on a scale from 0 no impact, to 100 greatest impact.","ALL","65 Years","85 Years",true,{"inclusion":69,"exclusion":80,"raw_text":98},[70,71,72,73,74,75,76,77,78,79],"Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2)","Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA","Are between 65-85 years of age","Report a frequent pain score between 4-7 (range: 0-10) during the week preceding enrollment","Report that knee pain negatively affects quality of life","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","Are deemed appropriate by their physician or by the study site physician to participate.","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.","Not use or initiate use of opioid and\u002For non-opioid analgesic medications.","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).",[81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97],"Cannot successfully demonstrate the ability to put on and take off the device.","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.","Participated in a clinical trial for an investigational drug and\u002For agent within 30 days prior to screening.","Is pregnant.","Is a prisoner.","Is non-ambulatory (unable to walk).","Has a pacemaker.","Has a malignancy in the treatment area.","Has an active infection, open sores, or wounds in the treatment area.","Has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia.","Has a known neuropathy (disease of the brain or spinal nerves).","Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage).","Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months.","Are currently taking steroids.","Have any contraindication to radiograph.","Have a secondary cause of arthritis (metabolic or inflammatory).","Have a known contraindication, allergy, or hypersensitivity to corticosteroids or any component of Kenalog®-40 (if assigned to the injection group).","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).",[100],"OLDER_ADULT",[102,117],{"facility":103,"city":104,"state":105,"zip":106,"country":107,"contacts":108,"geoPoint":114},"Orthopaedic Foundation","Stamford","Connecticut","06905","United States",[109],{"name":110,"role":111,"phone":112,"email":113},"Stephanie Petterson, PhD, MPT","CONTACT","203-869-2002","spetterson@ofals.org",{"lat":115,"lon":116},41.05343,-73.53873,{"facility":118,"city":119,"state":120,"zip":121,"country":107,"contacts":122,"geoPoint":127},"Cayuga Medical Center - Medical Pain Consultants","Dryden","New York","13053",[123],{"name":124,"role":111,"phone":125,"email":126},"Ralph Ortiz, DO, MPH","607-844-9979","drortizmpc@gmail.com",{"lat":128,"lon":129},42.49091,-76.29716,[131],{"name":124,"role":111,"phone":125,"email":126},[],[],[135],{"label":136,"url":137},"Class II Medical Device","https:\u002F\u002Fwww.samrecover.com",{"nct_id":4,"conditions":139,"biomarkers":141},[140],"Osteoarthritis",[],{"nct_id":4,"found":67,"summary":143,"prompt_version":153},{"design":144,"status":145,"heading":146,"summary":147,"follow_up":148,"word_count":149,"commitments":150,"compensation":151,"drugs_mentioned":152},"This interventional study plans to enroll 240 participants and compare three different treatments for knee osteoarthritis.","completed","Long Duration High Frequency Ultrasound for Knee Osteoarthritis","This study is looking at how well a device called the Sustained Acoustic Medicine (SAM) device, which uses high-frequency ultrasound, can help reduce knee pain from osteoarthritis. It's also testing if adding a 2.5% diclofenac patch (a pain-relieving medication) to the ultrasound treatment works better than ultrasound alone, or a single injection of triamcinolone acetonide (a steroid). You might be able to join if you are between 65 and 85 years old, have mild to moderate knee osteoarthritis, and experience frequent knee pain that affects your quality of life. The study will measure changes in your pain levels and how well you can use your knee over 12 weeks. The current status of this study is unclear.","Your pain and function will be measured through study completion, which is an average of 12 weeks.",117,"You would self-apply your assigned treatment daily for 1-4 hours over 12 weeks. You will also record pain scores daily and complete quality of life and function assessments at the beginning and end of the study.","Not stated in the trial record.",[],"v2"]