[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575545":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":57,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":26,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Barzilai Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard + B-Cure Pro","ACTIVE_COMPARATOR","Subjects from the Standard + B-Cure Pro group will receive standard care and in addition will self-treat at home with the B-Cure device",[13],"Device: B-Cure laser pro",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard + Sham","SHAM_COMPARATOR","Subjects from the Standard + Sham group will receive standard care and in addition will self-treat at home with the sham B-Cure device",[19],"Device: Sham",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","B-Cure laser pro","The B-Cure laser pro is a portal, non-invasive, photobiomodulation device, that emits light in the near infrared (808nm) over an area of 1X4.5 cm2 with power output of 250mW, and energy dose of 1J\u002Fcm2.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham","The sham device is externally identical to active, emits the same guiding light and sound but does not emit the therapeutic near infrared invisible rays",[15],[32],{"name":33,"affiliation":34,"role":35},"Omri Lubovsky, MD","Barzilai University Medical Center Ashkelon Israel","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Galia Cohen Peres, BA","CONTACT","+972-54-2211779","cohenperesg@bmc.gov.il",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":26},"Barzilai University Medical Center","RECRUITING","Ashkelon","Southern District","7830604","Israel","IL",{"type":52,"coordinates":53},"Point",[54,55],34.57149,31.66926,{"lat":55,"lon":54},{"type":35,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Omri Lubovsky","Head of Orthopedic Department","100575545","evaluating-the-effectiveness-of-using-a-home-laser-device-to-treat-patients-with-knee-osteoarthritis-100575545",false,"NCT06773676","Evaluating the Effectiveness of Using a Home Laser Device to Treat Patients With Knee Osteoarthritis","Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: A Double-Blind, Randomized, Sham-Controlled Clinical Study","Inclusion Criteria:\n\n1. Diagnoses of knee osteoarthritis by American College of Rheumatology (ACR)\n2. Kellgren \\& Lawrence classification 1-3\n3. Knee pain on movement 40 to 90 mm Visual Analog Scale\n4. Knee pain and related functional reduction for at least 1 month\n\nExclusion Criteria:\n\n1. Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control\n2. Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, radiculopathy etc) have been ruled out by physical examinations.\n3. Knee surgery for KOA\n4. Intra-articular steroid injection and\u002For oral steroid treatment within the last six months\n5. Rheumatoid arthritis\n6. Symptomatic OA in other joints (i.e. hip, hand)\n7. Use of narcotics on the day of evaluation\n8. Active malignancy\n9. Uncontrolled diabetes mellitus\n10. Neurological conditions: sciatica, neuropathy, multiple sclerosis\n11. Other chronic pain conditions that may affect results: Fibromyalgia, back pain, hip pain\n12. Has any photobiomodulation (low level laser) device at home or has previously used photobiomodulation for knee pain\n13. Has known dermatological sensitivity to light\n14. Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.","ALL","50 Years","90 Years",{"count":71,"type":72},50,"ESTIMATED","INTERVENTIONAL",[75],"NA","Osteoarthritis is a degenerative disease affecting joint cartilage and its surrounding tissue. It is the leading cause of disability in the elderly. Photobiomodulation (PBM), has been used widely for alleviation of pain, reduction of inflammation, and acceleration of wound healing, and particularly to treat knee osteoarthritis (KOA). The purpose of the current study is to determine if a near-infrared PBM device (B-Cure Laser), applied at home, by the patient or personal caregiver in a real-life situation, can reduce pain and improve functionality in patients with KOA.",[78],"Osteoarthritis Of Knee",[80,81],"Osteoarthritis","Knee Osteoarthritis","2025-01-13",{"date":84,"type":85},"2025-01-14","ACTUAL",{"date":84,"type":72},{"date":88,"type":72},"2027-01-31",{"name":5,"class":6},1]