[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"knee-osteoarthritis-knee-oa\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:knee-osteoarthritis-knee-oa":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,44,75,106,134,159,187,210,236,261,282,312,338,359,382,403,423,442,475,497,524,545,569],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100054131","effect-of-inspiratory-muscle-training-on-knee-osteoarthritis-pain-100054131",false,"NCT07698418","Effect of Inspiratory Muscle Training on Knee Osteoarthritis Pain","Effect of Inspiratory Muscle Training on Pain in Patients With Knee Osteoarthritis: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 55 years or older.\n* Knee osteoarthritis (Kellgren-Lawrence grade ≥ 2).\n* Knee pain (Visual Analogue Scale, VAS ≥ 3) on the most days in the past month.\n* Able to walk independently without assitive devices.\n\nExclusion Criteria:\n\n* History of knee replacement surgery, meniscus surgery, or ligament surgery.\n* Received corticosteroid injection within the previous three weeks.\n* Diagnosed with rheumatoid arthritis.\n* Unstable angina, recent myocardial infarction, uncontrolled cardiac arrhythmia, or severe heart failure.\n* History of stroke.\n* Currently receiving steroid therapy, hormonal therapy, or cancer chemotherapy.\n* Pneumothorax, pulmonary bullae, lung surgery within the past 12 months, unstable asthma, or severe dyspnea at rest.\n* Unable to understand the study procedures and potential risks.","ALL","55 Years","80 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"NA","Knee osteoarthritis (KOA) is a common joint disease that causes chronic pain and limits daily activities. Current treatments, such as painkillers or surgery, have limitations like side effects or high costs. This study will test whether a safe, non-drug intervention-inspiratory muscle training (breathing exercises against resistance)-can reduce knee pain in people with KOA. The training may work by lowering inflammation and improving the body's nervous system control of pain.\n\nWe plan to enroll 80 patients aged ≥55 years with confirmed KOA and frequent knee pain. Participants will be randomly assigned to either an 8-week inspiratory muscle training program (5 sessions per week, with gradually increasing resistance) or a sham (very low resistance) training program. Neither the patients nor the researchers assessing the outcomes will know who is in which group.\n\nThe main outcome is change in knee pain measured by a visual analog scale (VAS). Secondary outcomes include blood markers of inflammation (TNF-α, IL-6, IL1β), physical function, WOMAC score (a KOA-specific questionnaire), activity level, sleep quality, and quality of life. To explore underlying mechanisms, we will also measure heart rate variability (HRV) as an indicator of autonomic nervous system function, and brain functional connectivity in the prefrontal cortex using functional near-infrared spectroscopy (fNIRS). These mechanistic assessments will be performed at baseline and at the end of 8-week intervention. Additional follow-up assessments for clinical outcomes will be done at 3 and 6 months after the training ends. We will also record any side effects or adverse events.\n\nThis study will provide high-quality evidence on whether inspiratory muscle training is an effective and safe complementary treatment for knee pain in people with knee OA, and will offer new insights into the mechanisms underlying its analgesic effects.",[27,28],"Knee Osteoarthritis","Knee Osteoarthritis (Knee OA)",[27,30,31],"Inspiratory Muscle Training","Chronic Pain","NOT_YET_RECRUITING","2026-07-07",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":21},"2026-07-01",{"date":40,"type":21},"2030-07-01",{"name":42,"class":43},"The Hong Kong Polytechnic University","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100642196","high-intensity-laser-therapy-hilt-in-patients-with-knee-osteoarthritis-100642196","NCT07661407","High-Intensity Laser Therapy (HILT) in Patients With Knee Osteoarthritis","Assessment of the Effectiveness of High-Intensity Laser Therapy (HILT) in the Treatment of Knee Osteoarthritis: A Randomized Placebo-Controlled Trial","Inclusion Criteria:\n\n* Radiographically confirmed knee osteoarthritis\n* Mild-to-moderate disease severity\n* Pain ≥4 on VAS for at least 3 months\n* Ability to participate in physiotherapy\n* Informed consent\n\nExclusion Criteria:\n\n* Advanced OA requiring surgery\n* Previous knee arthroplasty\n* Knee instability\n* Acute inflammation\n* Neurological disorders affecting gait\n* Neuropathies or myopathies\n* Active inflammatory arthritis\n* Recent lower-limb injury (\\\u003C6 months)\n* Intra-articular injections within 3 months\n* Cancer, pregnancy, epilepsy\n* Electronic implants or pacemaker\n* Active local infection","40 Years","75 Years",{"count":54,"type":21},72,[24],"This randomized placebo-controlled trial aims to evaluate the effectiveness of High-Intensity Laser Therapy (HILT) as an adjunct to standard outpatient physiotherapy in patients with knee osteoarthritis. Seventy-two participants will be randomly assigned to receive either conventional physiotherapy combined with active HILT or conventional physiotherapy combined with sham HILT. Outcomes related to pain, knee function, physical performance, muscle strength, range of motion, psychosocial factors, quality of life and body composition will be assessed at baseline, after the intervention, and at 8-week follow-up.",[28],[59,60,27,61,62,63,64,65],"High-Intensity Laser Therapy","HILT","Gonarthrosis","Physiotherapy","Pain","KOOS","Randomized Controlled Trial","2026-06-24",{"date":68,"type":36},"2026-06-29",{"date":70,"type":21},"2026-07-03",{"date":72,"type":21},"2028-03-31",{"name":74,"class":43},"University of Rzeszow",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":86,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100576143","creation-of-a-prospective-data-collecting-registry-for-genicular-artery-embolization-for-arthritis-100576143","NCT06781463","Creation of a Prospective Data Collecting Registry for Genicular Artery Embolization for Arthritis","Creation of a Prospective Data Collecting Registry for Genicular Artery Embolization for Arthritis (GAE)","GAE","Inclusion Criteria:\n\n* Patients aged \\>=18\n* Bilateral or unilateral knee pain attributed to knee osteoarthritis (KOA). For bilateral KOA patients, the more severe knee will be permitted inclusion to the registry\n* Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale\n* Knee pain \\>6 months refractory to conservative medical management (Nonsteroidal anti-inflammatory drugs, acetaminophen, etc.)\n* Not eligible for surgical knee replacement or patient's personal preference to undergo Genicular Artery Embolization (GAE) for reasons such as minimally invasiveness of GAE\n\nExclusion Criteria:\n\n* Active malignancy\n* Active infection of the affected knee\n* Platelets \\\u003C50,000\u002FuL, INR \\>2.0 (unless on anticoagulation that can be reversed or performing radial\u002Fpedal access without reversal)\n* Corticosteroid injection of the affected knee within 3 months of enrollment\n* Rheumatoid arthritis or other seronegative arthropathy\n* Previous surgery (excluding arthroscopy) of the affected knee\n* Grade 4 per Kellgren-Lawrence Grading Scale of the affected knee\n* Pregnancy or expected pregnancy\n* Glomerular Filtration Rate (GFR) \\\u003C30\n* Anaphylactic reaction to iodinated contrast\n* Moderate to severe pain in other lower limb joints\n* Body weight \\>400 lbs. (prohibiting safe angiography)\n* Peripheral arterial disease of the treated extremity (Rutherford Grade 2 or greater)","18 Years",{"count":85,"type":21},100,"1 Year","OBSERVATIONAL","The goal of this study is to create a prospective registry (\\\u003C100 patients) to show the effectiveness of the genicular artery embolization procedure overtime in reducing bilateral or unilateral osteoarthritic knee pain as measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.",[27,28,90],"Knee Osteoarthritis (OA)",[92,93,94],"knee pain","knee replacement alternative","knee arthritis","RECRUITING","2026-05-12",{"date":98,"type":36},"2026-05-13",{"date":100,"type":36},"2023-10-01",{"date":102,"type":21},"2028-10-01",{"name":104,"class":43},"University of Chicago",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":105},"100618918","phase-2-phase-iiiii-randomized-trial-of-uc-msc-secretome-vs-sodium-hyaluronate-in-knee-osteoarthritis-100618918","NCT07337863","Phase II\u002FIII Randomized Trial of UC-MSC Secretome vs Sodium Hyaluronate in Knee Osteoarthritis","A Phase II\u002FIII Randomized Double-Blind Multicenter Study Comparing UC-MSC-Derived Secretome and Sodium Hyaluronate on Pain and Function in Patients With Kellgren-Lawrence Grade 2-3 Knee Osteoarthritis","SECRET-OA","Inclusion Criteria:\n\n1. Diagnosed with primary OA in one or both knees based on American College of Rheumatology (Clinical and Rheumatology criteria). If both knees have OA, the knee with the OA grade that falls within the inclusion criteria (grade 2-3) will be selected. If both knees meet the inclusion criteria, the knee with the highest grade and the one that is most uncomfortable will be chosen.\n2. Males or females in the age range 40-70 years\n3. Symptomatic knee OA (defined by pain at the affected joint for at least 3 months before inclusion and visual analog scale 40 - 70 mm on a 100 mm Visual Analog Scale (VAS).\n4. Radiographic evidence of grade 2 to 3 osteoarthritis (OA) based on Kellgren and Lawrence radiographic criteria.\n5. Body mass index between 18 - 30 kg\u002Fm2\n6. Female participants of childbearing age who agreed to use accepted methods of contraception during the course of the study.\n7. Ability to provide written informed consent and willing to participate the study\n\nExclusion Criteria:\n\n1. Participants who, based on physical examination and clinical history (anamnesis), are in the active or acute phase of cardiac, pulmonary, hematological, hepatic, renal, systemic autoimmune, immunodeficiency, or coagulation disorders that may interfere with the administration of the study drug (Secretome or Sodium Hyaluronate) will be excluded,\n2. Diagnosed with a meniscal rupture based on clinical history (anamnesis) and physical examination. If the anamnesis and physical examination show symptoms and signs of a meniscal rupture, further evaluation will be performed using ultrasound (USG),\n3. Participants with significant axial deviation, defined by valgus or varus deformity observed during physical examination, will be excluded,\n4. Participants with other pathological lesions on knee X-rays from the screening examination will also be excluded,\n5. History of any form of secondary arthritis in the knee due to trauma,\n6. History of surgery or major trauma to the knee joint\n7. Has knee effusion,\n8. Has any other inflammatory disorder of the knee joint\n9. Diagnosed with active malignancy.\n10. History of stem cell or secretome therapy.\n11. Intra-articular injection of corticosteroid and\u002For prior treatment with Sodium Hyaluronate and\u002For platelet rich plasma (PRP) in past 3 months.\n12. Use of NSAIDs and\u002For chondroprotective supplements, such as glucosamine and chondroitin sulfate, within 7 days before the trial, whether used orally, topically, or via injection,\n13. Undergoing immunosuppressive therapy, or anticoagulant therapy, or corticosteroid therapy.\n14. For women of child-bearing potential: positive pregnancy test or lactating (females who were planning pregnancy within the next year were excluded).\n15. Enrolled in any other clinical trials within the past four weeks.\n16. The principal investigator considers that the participant is ineligible for the clinical trial due to any reasons other than those listed above","70 Years",{"count":116,"type":21},50,[118,119],"PHASE2","PHASE3","This study is a randomized, double-blind, multicenter Phase II\u002FIII clinical trial designed to evaluate the effectiveness and safety of umbilical cord-derived mesenchymal stem cell (UC-MSC) secretome compared with sodium hyaluronate in patients with knee osteoarthritis. Knee osteoarthritis is a common degenerative joint disease that causes chronic pain and functional limitation. Participants will be randomly assigned to receive intra-articular injections of either UC-MSC-derived secretome or sodium hyaluronate. The study aims to assess improvements in knee pain, physical function, and overall clinical outcomes, as well as to evaluate the safety of the interventions over the study period.",[28],[27,123,65,124,125],"UC-MSC Secretome","Sodium Hyaluronate","Intra-articular Injection","2026-05-07",{"date":96,"type":36},{"date":129,"type":21},"2026-08-30",{"date":131,"type":21},"2027-12-24",{"name":133,"class":43},"Universitas Sriwijaya",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":141,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":4},"100634823","neuromuscular-control-and-motor-unit-behavior-in-patients-with-knee-osteoarthritis-100634823","NCT07544693","Neuromuscular Control and Motor Unit Behavior in Patients With Knee Osteoarthritis","Neuromuscular Control and Motor Unit Behavior in Patients With Knee Osteoarthritis: a Randomized Single-blind Trial of Muscle Training and Knee Orthosis Intervention","Inclusion Criteria:\n\n\\- 1. age 55 to 75 years.\n\n2\\. Diagnosed with moderate knee traumatic arthritis (Kellgren-Lawrence classification II or III)(experimental group).\n\nThe control group must not have a diagnosis of osteoarthritis of the knee and must have normal knee joint function.\n\n3\\. Physical Health Status: Able to perform basic movements requiring isometric knee contraction tests and electromyography recording.\n\n4\\. Able to wear knee orthotics.\n\nExclusion Criteria:\n\n* 1\\. Knee or lower extremity injury: Recent (within the past 6 months) history of severe injury, fracture, or surgery to the knee or lower extremity.\n\n  2\\. Other joint disorders: Coexisting joint disorders (such as rheumatoid arthritis or gouty arthritis).\n\n  3\\. Neuromuscular disorders: Presence of neuromuscular dysfunction, such as stroke, Parkinson's disease, or peripheral neuropathy.\n\n  4\\. Uncontrolled cardiovascular disease, hypertension, diabetes, or other medical conditions.\n\nTaking medications that affect neuromuscular function.\n\n5\\. Allergy or intolerance: Allergy to laboratory equipment (such as electromyography electrode gel) or knee brace materials.",true,{"count":143,"type":21},120,[24],"This study aims to examine the effects of moderate-intensity strength training, performed with or without an unloading knee orthosis (valgus-corrective or sham mode), on muscle function, motor unit behavior, and force modulation in patients with moderate knee osteoarthritis",[28],[148,149],"Orthotic Devices","knee osteoarthritis","2026-04-18",{"date":152,"type":36},"2026-04-22",{"date":154,"type":21},"2026-04-20",{"date":156,"type":21},"2027-12-31",{"name":158,"class":43},"Kaohsiung Veterans General Hospital.",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":166,"minAge":167,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":174,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":105},"100630027","effects-of-core-stabilization-exercises-in-female-patients-with-gonarthrosis-100630027","NCT07482332","Effects of Core Stabilization Exercises in Female Patients With Gonarthrosis","Randomized Controlled Study of the Effects of Core Stabilization Exercises in Addition to Knee Exercises in Female Patients With Gonarthrosis","Inclusion Criteria:\n\n* Kellgren-Lawrence 2-3 knee osteoarthritis\n* Female patient aged 40-65\n* Volunteer\n\nExclusion Criteria:\n\n* Having received physical therapy within the last month\n* Presence of neurological, cardiac, and respiratory problems\n* Less than 90 degrees of flexion in the knee and hip joints\n* Presence of any pathology in the lower extremity that may affect balance and function\n* History of lower extremity surgery\n* Severe visual, hearing, and speech impairment\n* Illiteracy in Turkish\n* Body mass index of 30 or higher","FEMALE","45 Years","65 Years",{"count":170,"type":21},40,[24],"Osteoarthritis (OA) is a non-inflammatory degenerative disease characterized by progressive deterioration of cartilage tissue, synovial membrane, and joint capsule, primarily affecting weight-bearing joints. Individuals with knee osteoarthritis exhibit weakness in the trunk and periarticular muscles. This loss of strength in the trunk and periarticular muscles increases the load on the joint, contributing to the development and progression of the disease. This study aimed to investigate the effects of core stabilization, applied in addition to knee muscle exercise programs, on clinical symptoms and functional capacity in individuals with knee osteoarthritis.",[28],[175,176,62,177],"Knee osteoarthritis","Core stabilization exercise","Function","2026-03-16",{"date":180,"type":36},"2026-03-19",{"date":182,"type":36},"2026-01-05",{"date":184,"type":21},"2026-09-14",{"name":186,"class":43},"Cumhuriyet University",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":193,"maxAge":18,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":105},"100629961","phase-1-pilot-and-feasibility-study-of-intra-articular-anti-cd14-for-the-treatment-of-knee-osteoarthritis-100629961","NCT07481474","Pilot and Feasibility Study of Intra-articular Anti-CD14 for the Treatment of Knee Osteoarthritis","Inclusion Criteria:\n\n* ACR Classification Criteria for Knee Osteoarthritis\n* Pain \\>=5 on Visual Analogue Scale\n* Kelgren-Lawrence Grade \\>1\n* Joint Effusion on Exam\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Serious or hospitalized infection in last 1 year\n* Poorly controlled crystal arthritis in last 6 months\n* Pain Pressure Threshold (PPT) testing \\\u003C=3\n* History of diagnosed fibromyalgia\n* Receipt of corticosteroid in affected knee within 3 months\n* Receipt of visco-supplementation or other intra-articular therapy (other than corticosteroid) within 6 months\n* Ongoing participation in another interventional study\n* Inability to ambulate without assistive device\n* Pregnancy or Lactation\n* History of knee arthroplasty in either knee\n* Symptomatic heart failure\n* Glomerular filtration rate \\\u003C45\n* Class III obesity (BMI\\>40 kg\u002Fm2)\n* Recent active malignancy (chemotherapy, radiation, or surgery within 3 months)\n* Poorly controlled diabetes (A1c\\>8%)\n* Rheumatoid Arthritis\n* Psoriatic Arthritis","50 Years",{"count":195,"type":21},30,[197],"PHASE1","Knee osteoarthritis (KOA) is a leading cause of chronic pain and disability among Veterans, which contributes significantly to reduced mobility, impaired quality of life, and increased health care utilization. First-line therapies, including non-steroidal anti-inflammatory drugs, physical therapy, and intra-articular corticosteroids, provide modest and short-term relief, while being associated with other side effects (i.e., potential for hastened cartilage loss) and no disease-modifying potential. Total knee arthroplasty, although effective, is not suitable for all patients and carries surgical risks. There is an unmet need for effective, durable, and locally-targeted therapies that can alleviate pain and improve function. The development of new therapies for this condition is thus a priority for the VA.\n\nWhile the therapy has been used in humans in other contexts, to date there are no data on the safety, feasibility, and potential efficacy of intra-articular IC14 administration in patients with KOA. A small-scale, Phase I \"first-in-joint\" pilot and feasibility trial is therefore critical to inform the design and implementation of larger, definitive studies. Specifically, preliminary data are needed to (1) determine the appropriate inclusion\u002Fexclusion criteria, (2) solidify the study design and study processes,(3) assess patient tolerance and acceptability of i.a. mAb injection, (4) evaluate safety profiles of the localized biologic intervention. Participants will be randomized into one of three arms, (a placebo arm, a low-dose arm, and a high-dose arm) and will be followed to evaluate the safety and feasibility of this treatment.",[28],"2026-03-13",{"date":202,"type":36},"2026-03-18",{"date":204,"type":21},"2026-06-01",{"date":206,"type":21},"2028-01-01",{"name":208,"class":209},"VA Office of Research and Development","FED",{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":168,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":223,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":105},"100595711","phase-1-recombinant-human-growth-hormone-rhgh-for-knee-osteoarthritis-korr-100595711","NCT07036003","Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR)","Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR): a Pilot, Randomized Placebo-controlled Trial","KORR","Inclusion Criteria:\n\n* Between 18 - 65 years old.\n* Diagnosis of isolated knee osteoarthritis for greater than 6 months.\n\nExclusion Criteria:\n\n* Previous or pending major intra-articular or reconstructive surgery to the involved knee, including femoral\u002Ftibial osteotomies, ligament repair\u002Freconstruction, or cartilage transplantation. Patients with remote (\\>1 year) diagnostic arthroscopy, arthroscopic debridement, meniscectomy, or meniscal repair may be allowed to participate at the investigators' discretion.\n* Previous major trauma (including fracture, dislocation, open injury) to the involved knee, or ipsilateral hip, knee, ankle, or hip. Patients with prior complete ligament tears will be excluded, patients with chronic partial thickness ligament tears or degenerative\u002Fcomplex meniscal tears (\\>6 months from injury) may be included at the investigators' discretion\n* Recent (less than 6 months) intra-articular injection into the involved knee.\n* High grade ligamentous knee injury.\n* Known allergy to recombinant human growth hormone (rHGH) or reconstitutive solutions.\n* BMI of less than 20 or greater than 35.\n* Documented history of growth disorder of bones or connective tissue, type 1 or 2 diabetes, myopathy, cancer, endocrine disorder, severe hypertension (SBP \\> 180) or rheumatologic disorder.\n* Pregnant or breastfeeding, or actively attempting to get pregnant.\n* Currently on hypoglycemic therapy, oral estrogen or glucocorticoid replacement therapy.\n* Would have difficulty with the self-injection schedule or other cognitive\u002F functional limitations.\n* Have taken creatine within 7 days before baseline. Potential participants will be given the option to pause their supplements and then re-screen if they are interested in the study,\n* Have taken anabolic steroids within 42 days (6 weeks) before baseline. Potential participants will be given the option to pause their supplements and then rescreen if they are interested in the study,\n* Vital signs or routine bloodwork outside of normal range.",{"count":219,"type":21},34,[197,118],"The goal of this clinical trial is to see if people with knee osteoarthritis would be willing to comply and adhere to incorporating Recombinant Human Growth Hormone (rHGH), specifically Saizen Somatropin solution, into their treatment plan.\n\nParticipants will be asked to:\n\n* Self-inject the treatment solution (placebo or somatropin) into the abdominal or gluteal area once per day for a total of 6 weeks.\n* Complete questionnaires related to their knee pain and activities of daily living.\n* Provide blood tests.\n* Complete various measurements including: circumference of thigh, calf, and abdomen; strength of thigh and knee; range of motion of both knees; and gait analysis.",[28,90],[224,225,226,27,227],"Recombinant Human Growth Hormone","rHGH","Saizen","Knee OA","2026-03-12",{"date":178,"type":36},{"date":231,"type":36},"2025-10-31",{"date":233,"type":21},"2029-01",{"name":235,"class":43},"Dr. David Wasserstein",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":22,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":105},"100628625","advanced-brain-imaging-tka-fmri-tka-100628625","NCT07464080","Advanced Brain Imaging-TKA (fMRI-TKA)","Brain Network-based Precision Medicine to Predict Dissatisfaction Following Total Knee Arthroplasty","fMRI-TKA","Inclusion Criteria:\n\n1. Male and female patients aged 18 years or older\n2. Primary TKA\n3. Diagnosis of osteoarthritis, inflammatory arthritis, or osteonecrosis\n\nExclusion Criteria:\n\n1. Inability or refusal to sign informed consent form\n2. Non-English or French speaking, and no licensed translator, family member or substitute decision maker available\n3. History of major neurological disorders (e.g traumatic brain injury, epilepsy, multiple sclerosis\n4. Cognitive impairment or dementia\n5. Revision and\u002For Bilateral TKA\n6. Chronic Opioid use",{"count":116,"type":21},[24],"Knee replacement surgery is a common and effective treatment for pain and mobility loss, yet up to 1 in 5 patients remain dissatisfied after surgery due to ongoing pain or difficulty with daily activities. Currently, clinicians cannot reliably predict which patients will experience these challenges.\n\nThis study uses MRI scan of the brain to investigate whether specific patterns of brain activity can predict patient satisfaction after total knee arthroplasty (TKA). By comparing brain networks before surgery and afterward, and linking these changes to patient-reported pain and function, we aim to identify brain-based markers that can help predict outcomes, to improve satisfaction after knee replacement surgery.",[28,248,249,250,251],"Knee Pain Chronic","Brain Network Connectivity","Patient Satisfaction","Brain MRI","2026-03-09",{"date":254,"type":36},"2026-03-11",{"date":256,"type":21},"2026-04-01",{"date":258,"type":21},"2028-12-31",{"name":260,"class":43},"Ottawa Hospital Research Institute",{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":268,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":270,"conditions":271,"keywords":272,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":281,"locationsCount":4},"100627040","evaluation-of-the-effects-of-pulsed-electromagnetic-field-on-inflammatory-knee-osteoarthritis-100627040","NCT07443462","Evaluation of the Effects of Pulsed Electromagnetic Field on Inflammatory Knee Osteoarthritis","Double-blind, Randomized Controlled Pilot Study to Assess the Effect of Pulsed Electromagnetic Field on Inflammatory Knee Osteoarthritis","Inclusion Criteria:\n\n1. Knee visual analogue scale (VAS) pain of \\\u003C40 mm (0-100 mm)\n2. Effusion-synovitis or Hoffa synovitis MRI semi-quantitative score of ≥2 (used to determine inflammatory subtype KOA);\n3. Kellgren-Lawrence (KL) grade II and III\n4. Patients can listen, speak, read, and understand Chinese; understand the pilot study's requirements and are willing to cooperate with the investigator in conducting the pilot study\n5. Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n1. Other inflammatory arthritis (e.g., gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, and seronegative spondyloarthropathy) and systemic lupus erythematosus.\n2. Participants with usual KOA interventions\u002F treatments\n3. History of knee trauma\n4. Contraindications to MRI\n5. Administration of intra-articular, intramuscular, and oral glucocorticoids within the last 4\n6. Pregnancy and lactation",{"count":116,"type":21},[24],"This study will assess the efficacy of pulsed electromagnetic field therapy in patients with inflammatory knee osteoarthritis confirmed by MRI-detected effusion-synovitis. Fifty participants will be randomly allocated into two groups. One group will receive active PEMF therapy at a specific optimized parameter twice a week for 8 weeks, while the other group will receive sham treatment using the same device without PEMF signal. The primary outcome is the change in WOMAC pain score, and secondary outcomes include knee function, stiffness, quality of life, and MRI-quantified structural changes.",[28],[273,175,274],"Pulsed electromagnetic field therapy","Inflammatory subtype","2026-02-27",{"date":277,"type":36},"2026-03-02",{"date":279,"type":21},"2026-02-15",{"date":258,"type":21},{"name":42,"class":43},{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":16,"minAge":168,"maxAge":18,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":291,"briefSummary":292,"conditions":293,"keywords":295,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":105},"100563088","analysis-of-the-loss-of-muscle-force-power-and-motor-control-to-predict-the-risk-of-falls-in-patients-with-knee-oa-100563088","NCT06611618","Analysis of the Loss of Muscle Force, Power and Motor Control to Predict the Risk of Falls in Patients With Knee OA","Analisi Della Perdita di Forza e Potenza Muscolare e Del Degrado Del Controllo Motorio Per la Predizione Delle Cadute in Una Popolazione Affetta da Artrosi di Ginocchio","PowerAGING","Inclusion Criteria:\n\n* Age between 65 and 80 years\n* Kellgren score II e III\n* No history of falls in the last 12 months\n\nExclusion Criteria:\n\n* Any musculoskeletal, neurological, rheumatic or tumoral diseases\n* Dementia\n* Diabetes\n* Inguinal or abdominal hernia\n* Severe Hypertension (Level 3)\n* Severe Cardio-pulmonary insufficiency\n* Diagnosis of Osteonecrosis in the lower limb joints\n* Pathologies or physical conditions incompatible with the use of magnetic resonance imaging and electrostimulation (i.e., active and passive implanted biomedical devices, epilepsy, severe venous insufficiency in the lower limbs)\n* Previous interventions or traumas to the joints of the lower limb",{"count":116,"type":21},[24],"The twofold goal of this study is to understand the link between muscle power, muscle strength, and muscle control degradation with the risk of falling, and to develop a framework for the comprehensive and quantitative assessment of muscle power (and strength) in an elderly population of patients with knee osteoarthritis, who are at higher risk of falling. The main question it aims to answer is:\n\n● Are muscle power and motor control degradation better predictors of falls than muscle strength in the aging population?\n\nParticipants will undergo:\n\n* Muscle force assessment on a dynamometer\n* Muscle power assessment on a dynamometer and on isntrumented stairs\n* Home-based mobility monitoring\n* Full lower limb MRI acquisition\n* Gait assessment",[28,294],"Falls Prevention",[296,175,297,298,299,300,301,302,303],"Falls prevention","Muscle power","Muscle force","Motor control degradation","digital twins","IMU","mobility monitoring","MRI","2026-02-24",{"date":275,"type":36},{"date":307,"type":36},"2025-01-30",{"date":309,"type":21},"2026-12-12",{"name":311,"class":43},"Istituto Ortopedico Rizzoli",{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":16,"minAge":318,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":22,"phases":321,"briefSummary":322,"conditions":323,"keywords":324,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":105},"100618238","an-implementation-science-approach-to-evaluating-self-administered-acupressure-for-knee-osteoarthritis-in-older-aged-adults-in-the-community-100618238","NCT07329023","An Implementation Science Approach to Evaluating Self-Administered Acupressure for Knee Osteoarthritis in Older-Aged Adults in the Community","Inclusion Criteria:\n\n1. ethnic Chinese;\n2. aged 60 years or above;\n3. able to read Chinese and comprehend Mandarin or Cantonese;\n4. fulfilling any 3 of the following criteria. i. morning stiffness 30 min; ii. crepitus on active joint motion; iii. bone tenderness; iv. bone enlargement; or v. no palpable joint warmth (this classification on those with age \\>50 years yielded 84% sensitivity, and 89% specificity for OA knee diagnosis (25));\n5. having knee pain for at least 3 months (26);\n6. knee pain 23 on a Likert pain scale from 1-10;\n7. having a smartphone (or a family member living together having a smartphone) that is compatible with WhatsApp (based on our previous studies, almost every eligible subject is used to using WhatsApp for social communication); and\n8. willing to provide informed consent.\n\nExclusion Criteria:\n\n1. medical diagnoses or conditions that preclude individuals from active participation (e.g., bleeding disorders, alcohol, or drug abuse);\n2. knee pain related to other conditions (cancer, fracture, rheumatoid arthritis, and rheumatism) as screened according to the red flags for further investigation or referral in the NICE 2014 Guidelines for Osteoarthritis of the knee (27);\n3. score \\\u003C 22 in Hong Kong Montreal Cognitive Assessment (HK-MoCA) indicating cognitive impairment that may prevent the understanding of training instructions (28);\n4. body mass index over 30, the obese Il criteria for Asians (29) (obese subjects will find great difficulty in performing acupressure on acupoints because physical pressure reaching the muscle is required); and\n5. ever had knee-replacement surgery\n\nFurther investigation or referral, either at the screening or during the study, will be made whenever necessary.","60 Years",{"count":320,"type":21},368,[24],"This study aims to evaluate the implementation and effectiveness of a self-administered acupressure (SAA) program for knee osteoarthritis (OA) among older adults in Hong Kong community centers. Using a pragmatic cluster randomized controlled trial (RCT) and mixed-methods approach, the research will assess the reach, adoption, implementation, maintenance, and effectiveness of the SAA program in real-world settings, with the goal of informing scalable interventions for knee OA management.",[28],[325,326,327,328,329],"knee OA","RCT","pain","osteoarthritis","implementation sciences","2025-12-28",{"date":332,"type":36},"2026-01-09",{"date":334,"type":21},"2025-12-20",{"date":336,"type":21},"2028-05-30",{"name":42,"class":43},{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":114,"enrollmentInfo":345,"targetDuration":4,"studyType":22,"phases":347,"briefSummary":348,"conditions":349,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":105},"100614817","intelligent-precision-knee-preservation-system-for-knee-osteoarthritis-100614817","NCT07284524","Intelligent Precision Knee Preservation System for Knee Osteoarthritis","The Dynamic Dual-Mode Alignment Optimization and Intelligent Precision Knee Preservation System for Knee Osteoarthritis","Inclusion Criteria:\n\n1. Age between 40 and 70 years;\n2. Unilateral medial compartment knee osteoarthritis (mild to moderate pain);\n3. Mild to moderate varus deformity (5°-15°);\n4. Coronal MRI showing medial meniscus extrusion (MME) \\>3 mm and flexion contracture \\\u003C10°;\n5. Intact lateral meniscus and articular cartilage;\n\nExclusion Criteria:\n\n1. Patients with concomitant inflammatory arthritis (e.g., rheumatoid arthritis) or systemic inflammatory diseases;\n2. Patients with severe varus deformity (\\>10°) or flexion contracture \\>10°;\n3. Patients with lateral meniscus pathology (tear, discoid meniscus) or knee joint instability;\n4. Patients with a history of major knee trauma, infection, or prior knee surgery;\n5. Patients with severe patellofemoral osteoarthritis;\n6. Patients with advanced medial compartment osteoarthritis (bone-on-bone contact or knee subluxation);\n7. Patients who refuse second-look arthroscopy or participation in the study;\n8. Patients unable to complete at least 12 months of follow-up;\n9. Patients with severe osteoporosis;\n10. Patients with cognitive impairment.",{"count":346,"type":21},150,[24],"The goal of this clinical trial is to verify whether the \"dynamic dual-mode alignment optimization + intelligent precision knee-preserving system\" (integrating static\u002Fkinematic target alignment, CT-based preoperative three-dimensional \\[3D\\] planning, 3D-printed guide plates, and intraoperative augmented reality \\[AR\\] real-time feedback) achieves a greater relative reduction in peak knee adduction moment (KAM) at 12 months postoperatively, while maintaining or improving knee clinical function and without increasing perioperative or long-term complication rates, compared with traditional knee-preserving strategies. The target population is patients aged 40-70 years with knee osteoarthritis (KOA; Kellgren-Lawrence grade II-III) who require high tibial osteotomy (HTO) for unilateral medial-compartment disease with mild-to-moderate varus deformity and who meet the inclusion and exclusion criteria.\n\nThe main questions are:\n\n* Can the dynamic dual-mode alignment + intelligent precision system achieve a greater relative reduction in peak KAM at 12 months postoperatively than traditional knee-preserving strategies?\n* Can this system improve static alignment accuracy, dynamic load parameters (e.g., KAM impulse and varus thrust), and patient-reported outcome (PRO) scores without increasing complication rates?\n* Can 3D-printed patient-specific instrumentation (PSI) guide plates and real-time AR feedback reduce intraoperative radiation exposure and shorten operative time compared with traditional methods?\n\nResearchers will compare:\n\nKinematic alignment (KA), traditional mechanical alignment (MA), and dynamic dual-mode alignment (DA) to evaluate the relative performance of alignment strategies;\n\n3D-printed PSI-guided HTO versus traditional fluoroscopy-guided HTO to assess the efficacy of PSI; and\n\nAR-assisted intraoperative adjustment versus traditional fluoroscopy-based adjustment to evaluate the precision of AR navigation.\n\nParticipants will:\n\n* Complete preoperative assessments, including laboratory tests (complete blood count, biochemistry, coagulation), imaging (full-length, weight-bearing lower-limb radiographs; knee CT and\u002For MRI as indicated), 3D gait analysis (to measure KAM, KAM impulse, and varus thrust), and PRO assessments (KOOS, WOMAC, and Lysholm scores)\n* Receive assigned surgical interventions: the DA group will undergo HTO guided by dual-mode alignment plus 3D-printed PSI and intraoperative AR feedback; the MA and KA groups will undergo HTO based on traditional or kinematic alignment, respectively; the traditional HTO group will undergo surgery relying on intraoperative fluoroscopy and surgeon experience.\n* Attend follow-up visits at 6 weeks, 3 months, 6 months, and 12 months postoperatively, including imaging to assess alignment accuracy and bone healing, gait analysis, PRO assessments, and complication monitoring.\n* Record medication use and rehabilitation compliance throughout the study period.",[28],"2025-12-02",{"date":352,"type":36},"2025-12-16",{"date":354,"type":21},"2026-01-01",{"date":356,"type":21},"2027-06-30",{"name":358,"class":43},"First Affiliated Hospital of Wenzhou Medical University",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":22,"phases":369,"briefSummary":370,"conditions":371,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":105},"100583149","randomized-controlled-study-evaluating-genicular-artery-embolization-against-intra-articular-corticosteroid-knee-injection-for-osteoarthritic-knee-pain-100583149","NCT06872567","Randomized Controlled Study Evaluating Genicular Artery Embolization Against Intra-Articular Corticosteroid Knee Injection for Osteoarthritic Knee Pain","Resorbable Embolization MicroSpheres for OsteoaRthritis Benefit","RESORB","Inclusion Criteria:\n\n* Patient has localized knee pain\n* Must be an appropriate candidate for arterial vascular access procedure\n\nExclusion Criteria:\n\n* Known sensitivity or allergy to implant materials\n* Unable or unwilling to comply with study requirements",{"count":368,"type":21},126,[24],"Multi-center, prospective, randomized trial of GAE using Nexsphere-F against steroid injection",[28],"2025-11-19",{"date":374,"type":36},"2025-11-24",{"date":376,"type":36},"2025-10-01",{"date":378,"type":21},"2026-12",{"name":380,"class":381},"North American Science Associates Ltd.","NETWORK",{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":16,"minAge":193,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":390,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":402},"100587614","study-in-patients-with-knee-osteoarthritis-treated-by-embolization-using-nbgm200-100587614","NCT06930677","Study in Patients With Knee Osteoarthritis Treated by Embolization Using NBGM200","A Prospective, Single-arm, Multinational, Multi-center, Clinical Study to Evaluate the Performance and Safety of Musculoskeletal Embolization Using NBGM200 in Patients With Knee Degenerative Osteoarthritis","Inclusion Criteria:\n\n* Osteoarthritis proven by MR-imaging\n\nExclusion Criteria:\n\n* Current local infection\n* Life expectancy less than 6 months",{"count":54,"type":21},[24],"Study in patients with knee osteoarthritis treated by embolization using NBGM200",[28],"2025-11-17",{"date":372,"type":36},{"date":396,"type":36},"2025-04-17",{"date":398,"type":21},"2027-02",{"name":400,"class":401},"Next Biomedical Co., Ltd.","INDUSTRY",3,{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":11,"sex":16,"minAge":193,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":105},"100602985","validation-and-reliability-of-the-vietnamese-pain-self-efficacy-questionnaire-in-knee-osteoarthritis-100602985","NCT07130630","Validation and Reliability of the Vietnamese Pain Self-Efficacy Questionnaire in Knee Osteoarthritis","Validation and Reliability of the Vietnamese Version of the Pain Self-Efficacy Questionnaire in Patients With Knee Osteoarthritis","Inclusion Criteria:\n\nParticipants will be eligible for inclusion if they meet all of the following conditions:\n\n* Age ≥ 50 years.\n* Diagnosis of knee osteoarthritis (OA) according to the criteria of the American College of Rheumatology (ACR), confirmed by:\n\n  1. application of ACR criteria by the investigator at the time of enrollment; or\n  2. a prior diagnosis documented in medical records by a rheumatologist or musculoskeletal specialist.\n* Presence of chronic pain related to knee OA, with current pain intensity ≥ 1 on the Visual Analog Scale (VAS).\n* No acute flare of knee pain within the past 2 weeks.\n* Ability to perform activities of daily living (with or without assistance).\n* Ability to read, understand, and complete questionnaires in Vietnamese.\n* Willingness to participate and provide informed consent.\n\nExclusion Criteria:\n\nParticipants will be excluded if they meet any of the following conditions:\n\n* Diagnosis of severe psychiatric disorders (e.g., schizophrenia, severe anxiety disorders).\n* Presence of cognitive impairment that interferes with the ability to comprehend or answer the questionnaire.\n* Diagnosed with systemic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus, or gout.\n* Presence of other chronic pain conditions (unrelated to knee OA) that are predominant and significantly affect mobility and daily functioning.\n* History of intra-articular injection or knee surgery within the past 3 months.\n* Questionnaire (PSEQ) with ≥ 20% of items missing or invalid.",{"count":411,"type":21},173,"This study aims to evaluate the reliability and convergent validity of the Vietnamese version of the Pain Self-Efficacy Questionnaire (VIET-PSEQ) in patients with knee osteoarthritis (KOA). Pain self-efficacy refers to a person's confidence in managing their pain and maintaining daily activities despite it.\n\nA total of 173 patients with KOA will be recruited at Gia Dinh People's Hospital using a convenient sampling method. Eligible participants are 50 years or older, diagnosed with KOA, and experiencing chronic knee pain. They will complete the VIET-PSEQ and other health-related questionnaires during an in-person interview.\n\nThe study will assess internal consistency (using Cronbach's alpha), test-retest reliability (by re-assessing a subgroup after 72 hours), and convergent validity by correlating VIET-PSEQ scores with EQ-5D-5L utility index. Additionally, linear regression analysis will examine how age, sex, pain severity, and education level influence pain self-efficacy.\n\nThe goal is to determine whether VIET-PSEQ is a reliable and valid tool for measuring pain self-efficacy in Vietnamese patients with KOA.",[28],"2025-08-12",{"date":416,"type":36},"2025-08-19",{"date":418,"type":36},"2025-07-14",{"date":420,"type":21},"2025-12-31",{"name":422,"class":43},"Khai Quang Nguyen, MD",{"id":424,"slug":425,"hasResults":11,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":430,"targetDuration":4,"studyType":22,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":438,"leadSponsor":440,"locationsCount":105},"100581072","phase-2-a-study-to-assess-the-efficacy-and-safety-of-vutiglabridin-in-knee-osteoarthritis-patients-100581072","NCT06845553","A Study to Assess the Efficacy and Safety of Vutiglabridin in Knee Osteoarthritis Patients","A Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, Phase 2a Clinical Trial to Explore the Efficacy and Evaluate the Safety of Vutiglabridin in Knee Osteoarthritis Patients Following 26 Weeks of Oral Treatment","Inclusion Criteria:\n\n1. Voluntarily agreed to participate in the study after being informed about the nature of the trial and has signed the informed consent form approved by the IRB.\n2. Adults aged 40 to 75 years at the time of screening.\n3. Meets the American College of Rheumatology (ACR) criteria for osteoarthritis and has symptoms lasting for more than 3 months requiring pharmacological treatment. Must have knee pain and radiographic evidence of osteophytes, with at least one of the following:\n\n   * Age 50 or older\n   * Morning stiffness less than 30 minutes\n   * Crepitus on knee motion\n4. Has a Kellgren-Lawrence grade II or III in the knee joint on X-ray at the time of screening.\n5. Experiences a maximum pain of 50 mm or greater on the 100 mm VAS in activity over the past 24 hours at screening and baseline.\n6. For females, the following conditions apply:\n\n   * For women of childbearing potential, the serum hCG pregnancy test at screening must be negative, confirming not pregnant.\n   * Not currently breastfeeding.\n   * Has undergone surgical sterilization (documented bilateral tubal ligation, bilateral tubal occlusion, bilateral oophorectomy, or hysterectomy), or is postmenopausal.\n\n     * Definition of menopause:\n   * For women over 50 years: 12 months of natural amenorrhea.\n   * For women under 50 years: Serum FSH level over 40 IU\u002FL and 12 months of natural amenorrhea.\n\nExclusion Criteria:\n\n1. BMI of 35.0 kg\u002Fm² or higher at screening.\n2. Developed a clinically significant new disease within 4 weeks before screening or during the screening period, as judged by the investigator.\n3. Has arthritis in joints other than the knee.\n4. Has any other joint disease except knee osteoarthritis (e.g., secondary osteoarthritis due to trauma, congenital defects, calcium deposition diseases, rheumatoid arthritis, gouty arthritis, Paget's disease, systemic inflammatory disorders, chondrocalcinosis, hemachromatosis, inflammatory arthritis, avascular necrosis, etc.).\n5. Has a history of knee or other joint surgery.\n6. Has received injections in the affected knee before the administration of the study drug:\n\n   * Steroid injections within 3 months (13 weeks) to the knee osteoarthritis area.\n   * Short-acting hyaluronic acid injections within 3 months (13 weeks) to the knee osteoarthritis area.\n   * Long-acting hyaluronic acid injections within 6 months (26 weeks) to the knee osteoarthritis area.\n7. Has received drug therapy for pain control or symptom improvement in the knee joint area within 4 weeks before study drug administration (opioid analgesics, non-opioid analgesics, topical capsaicin, NSAIDs, anticonvulsants, and other treatments like physical therapy, prolotherapy, herbal treatment, glucosamine, chondroitin).\n8. Expected to undergo surgery during the clinical trial period that may affect study completion or adherence to the clinical protocol.\n9. Has neuropathic pain or has taken neuropathic pain medications (gabapentinoids, SNRIs, tricyclic antidepressants) within 4 weeks before screening.\n10. Has a history of myocardial infarction, unstable angina, stroke, transient ischemic attack, or deep vein thrombosis within 3 months (13 weeks) before screening.\n11. Has any clinically significant untreated or unstable diseases of the liver, kidney, nervous system, immune system, respiratory system, endocrine system, blood\u002Foncologic diseases, cardiovascular diseases, psychiatric disorders, neoplastic diseases, or any other conditions deemed unsuitable for participation by the investigator.\n12. For males, has a history of hypogonadism or known causes of hypogonadism (e.g., prostate cancer treatment), infertility, Klinefelter syndrome, or Kalman syndrome.\n13. Has used medications that can alter reproductive hormone levels (e.g., anabolic steroids, androgens, anti-estrogens, glucocorticoids, opiates, etc.) within 6 months (26 weeks) before screening.\n14. Has a history of organ transplantation.\n15. Has clinically significant liver dysfunction (e.g., AST or ALT more than 2.5 times the upper limit of normal, total bilirubin more than twice the upper limit of normal \\[except documented Gilbert's syndrome\\]) or kidney dysfunction (GFR \\\u003C60 mL\u002Fmin).\n16. Tests positive for HBsAg, HCV Ab, HIV Ag\u002FAb, or VDRL (RPR) at screening.\n17. Has a history of malignant tumors within the past 5 years (except for those with completely treated basal cell carcinoma, in situ carcinoma, thyroid cancer, or squamous cell carcinoma of the skin, based on the investigator's medical judgment).\n18. Has used systemic steroids for 7 or more consecutive days within 3 months (13 weeks) before screening.\n19. Has taken immunosuppressive drugs including methotrexate or antimetabolites within 3 months (13 weeks) before screening.\n20. Taking drugs that are substrates of the breast cancer resistant protein (BCRP) (e.g., rosuvastatin, sulfasalazine) at screening (however, can be eligible if switched to a different drug in the same class).\n21. Has a history of alcohol or drug abuse within 2 years before screening or tests positive for substance abuse at screening (except for documented chronic pain treatment with prescribed medications approved by the investigator).\n22. Has participated in another clinical trial or bioequivalence study within 6 months (26 weeks) before the first dose and received investigational medicinal products (except for placebo).\n23. Has a history of hypersensitivity or allergic reactions to any components of the investigational medicinal product.\n24. Has lactose intolerance.\n25. Unwilling to use medically acceptable contraception during the clinical trial period and for 90 days after the last dose.\n\n    * Medically acceptable contraception includes:\n    * Oral hormonal contraceptives for female partners of male subjects.\n    * Intrauterine devices with proven pregnancy failure rate.\n    * Surgical sterilization (e.g., vasectomy, tubal ligation, hysterectomy).\n26. Unwilling to donate sperm\u002Feggs during the trial or for 90 days after the last dose.\n27. Deemed unsuitable for participation in the trial based on clinical laboratory results or other reasons determined by the investigator.",{"count":431,"type":21},60,[118],"1. Study Objective To Explore the Efficacy and Evaluate the Safety of Vutiglabridin in Knee Osteoarthritis Patients\n2. Background Glaceum Inc. has evaluated the safety, tolerability, and pharmacokinetic\u002Fpharmacodynamic properties of vutiglabridin in healthy subjects through its Phase 1 trials, and is planning to perform this Phase 2a trial to assess the efficacy and safety of vutiglabridin in Knee Osteoarthritis Patients\n3. Study Design and Protocol This study is a randomized, double-blind, placebo-controlled, parallel-group trial. Subjects deemed eligible to participate in this study based on the inclusion\u002Fexclusion criteria will be assigned a subject number and randomized to one of the 3 treatment groups - 1 group receiving a placebo - in a 1:1:1 ratio. Subjects will be randomized to double-blind treatments and will receive a once-daily oral dose of the investigational product for 26 weeks according to the study protocol. Several parameters (i.e., 100mm VAS, WOMAC pain subscale, X-ray, MRI, BMI) will be evaluated to assess the efficacy of vutiglabridin. Assessments including measurement of vital signs, 12-lead ECG, clinical laboratory test, pregnancy test, physical examination, and adverse event monitoring will be performed to evaluate the safety and tolerability of vutiglabridin. Blood samples will be collected for pharmacokinetic assessment.",[28],{"date":436,"type":36},"2025-08-15",{"date":416,"type":21},{"date":439,"type":21},"2026-12-31",{"name":441,"class":401},"Glaceum",{"id":443,"slug":444,"hasResults":11,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":18,"enrollmentInfo":450,"targetDuration":4,"studyType":22,"phases":451,"briefSummary":452,"conditions":453,"keywords":454,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":105},"100582119","phase-2-genicular-artery-embolization-for-reducing-pain-in-medically-refractory-symptomatic-knee-osteoarthritis-100582119","NCT06859164","Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis","Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study","SHAM-PAIN","Inclusion Criteria:\n\n* Patients aged 40-80\n* Bilateral or unilateral knee pain attributed to osteoarthritis (treat the knee with greater pain-if equal, patient chooses)\n* Grade 2-4 osteoarthritis on standing weight-bearing knee radiographs per the Kellgren-Lawrence grading scale\n* Knee pain \\> 6 months, refractory to conservative non-operative management, and scored ≥ 4 on Visual Analog Scale (VAS) (e.g., rest, activity modification, weight control, bracing, supervised physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, oral opiates, intra-articular hyaluronic acid, PRP, stem cells, and\u002For oral\u002Finjectable corticosteroids)\n* Refusal of intra-articular corticosteroid injection\n\nExclusion Criteria:\n\n* Active malignancy\n* Active infection of the affected knee\n* Corticosteroid injection of the affected knee within 3 months of enrollment\n* Rheumatoid arthritis or other seronegative arthropathy\n* Previous surgery of the affected knee (e.g., meniscus repair, meniscectomy, anterior cruciate ligament (ACL)\u002Fposterior cruciate ligament (PCL) reconstruction, chondroplasty, microfracture, loose-body removal, synovectomy, lateral release, patellar\u002Fquadriceps tendon repair, total or partial knee replacement, osteotomy, cartilage transplant), except diagnostic arthroscopy\n* Grade 0-1 osteoarthritis per Kellgren-Lawrence grading scale of the affected knee\n* Pregnancy or expected pregnancy\n* GFR \\\u003C 60 mL\u002Fmin\u002F1.73 m²\n* Anaphylactic reaction to iodinated contrast\n* Moderate to severe pain in other ipsilateral lower-limb joints (ankle, hip) with VAS \\> 4\n* Body weight \\> 400 lbs (unsafe for angiography)\n* Peripheral arterial disease of the treated extremity (Rutherford Grade 2 or greater)\n* Type 1 diabetes mellitus\n* Long-acting corticosteroid use within 6 months (3 months for short-acting)\n* History or other evidence of acute kidney injury (AKI)\n* History of reaction to contrast media, bronchial asthma, or allergic disorders\n* History of hypersensitivity to gadolinium-based contrast agents (GBCAs)\n* Chronic widespread generalized pain \\>4 on VAS pain scale, including neuropathic pain\n* Major depressive disorder within 2 years before screening\n* Other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)\n* Suicide attempt or suicidal behavior within 30 days before screening\n* Diagnosis of fibromyalgia\n* Considering total knee replacement in the next year\n* Any other condition, unwillingness, or inability that, in the investigator's opinion, could jeopardize the subject's safety or protocol compliance",{"count":116,"type":21},[118],"Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. Additionally, this study aims to determine the magnitude of difference in pain response between GAE and sham to adequately power a larger, more definitive randomized sham-controlled trial (RCT). The influence of psychosocial and psychocognitive factors, changes in analgesic use, and conditions of knee joint cartilage and effusion will similarly be explored to determine their impacts on perceived pain response to GAE.",[27,28,90],[455,456,457,458,459,81,460,461,462,463,464,465,466],"Osteoarthritis","Knee pain","MSK pain","Musculoskeletal Pain","Osteoarthritis of the knee","Genicular artery embolization","Geniculate artery embolization","MSK embolization","Musculoskeletal Embolization","Embolization","Musculoskeletal","Temporary Embolization","2025-05-14",{"date":469,"type":36},"2025-05-15",{"date":471,"type":36},"2025-05-01",{"date":473,"type":21},"2026-11-30",{"name":104,"class":43},{"id":476,"slug":477,"hasResults":11,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":141,"sex":16,"minAge":51,"maxAge":318,"enrollmentInfo":482,"targetDuration":4,"studyType":22,"phases":483,"briefSummary":484,"conditions":485,"keywords":486,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":496},"100584951","retro-walking-versus-forward-walking-training-using-underwater-treadmill-in-patients-with-knee-osteoarthritis-100584951","NCT06896032","Retro-walking Versus Forward-walking Training Using Underwater Treadmill in Patients With Knee Osteoarthritis","Effect of Retro-walking Versus Forward-walking Training Using Underwater Treadmill on Pain and Function in Patients With Knee Osteoarthritis","Inclusion Criteria:\n\n1. 60 patients with chronic knee OA.\n2. Age ranges from 40-60 years old of both genders.\n3. body mass index (BMI) 25- 35kg\u002Fm2.\n4. The degree of osteoarthritis was mild or moderate and have a Kellgren- Lawrence radiographic grade of of1-3.\n5. unilateral knee osteoarthritis involvement.\n\nExclusion Criteria:\n\n1. hydrophobia.\n2. pregnancy.\n3. infection.\n4. psychiatric disorder.\n5. haemorrhagic diathesis.\n6. cardiac pacemaker.\n7. all Subjects with deformity of hip, knee \\& ankle.\n8. any CNS or PNS involvement.\n9. recent steroidal or intraarticular injections (3 months).\n10. systemic inflammatory disease and bone malignancy.",{"count":431,"type":21},[24],"The purpose of this study Will investigate and compare the effects of retro-walking and forward-walking underwater treadmill training on pain, function and ROM in subjects with chronic knee OA",[28,455],[27],"2025-04-13",{"date":489,"type":36},"2025-04-16",{"date":491,"type":36},"2025-03-30",{"date":493,"type":21},"2025-07-25",{"name":495,"class":43},"Nourhan Atwa Said",2,{"id":498,"slug":499,"hasResults":11,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":318,"enrollmentInfo":504,"targetDuration":4,"studyType":22,"phases":506,"briefSummary":507,"conditions":508,"keywords":509,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":105},"100583399","effects-of-feldenkrais-exercises-in-knee-osteoarthritis-patients-100583399","NCT06875817","Effects of Feldenkrais Exercises in Knee Osteoarthritis Patients","Effects of Feldenkrais Exercises on Pain, Range of Motion, and Disability in Patients With Knee Osteoarthritis","Inclusion Criteria:\n\n* Age between 40 to 60 years of patients.\n* Both female and male\n* Able to walk for 6 minutes (Timed up-and-go test)\n* Able to rise from floor\n* Grade 2 and 3 of osteoarthritis diagnosed with radiograph (Kellgren and Lawrence classification system)\n* Pain reported on VAS score ˃6\u002F10 in knee region for more than 3 months\n\nExclusion Criteria:\n\n* • Tuberculosis, carcinoma, heart disease, and osteoporosis\n\n  * Any trauma or localized infection in the knee joint\n  * Hyper flexibility\n  * Open sores\n  * Ongoing radiotherapy, chemotherapy, steroid therapy, or anticoagulants\n  * Psychiatric diseases such as phobia\u002Fobsession and depression\n  * Allergy to hot pack\n  * Patients with a history of surgery in the knee region within a year.\n  * Severe cognitive impairments\n  * Contraindications to physical activity\n  * Concurrent participation in other physical therapy programs",{"count":505,"type":21},32,[24],"The primary objective of the study is to determine the effects of Feldenkrais Exercises on Pain, Range of Motion, and Disability in Patients with Knee osteoarthritis. Knee osteoarthritis poses significant challenges in pain management, mobility improvement, and disability reduction among middle-aged to older adults. Feldenkrais Method offers benefits comparable to back school lessons or core stability exercises. This study, conducted as a Randomized Controlled Trial at RIPHAH Rehabilitation Clinic, aims to assess the efficacy of Feldenkrais exercises compared to conventional physical therapy in addressing pain, range of motion, and disability in knee osteoarthritis patients aged 40-60 years. A non-probability convenience sampling method will recruit 32 participants meeting specific criteria for osteoarthritis severity and functional ability. Participants will be randomly assigned to Group A (Feldenkrais exercises) or Group B (conventional therapy), with interventions delivered over four weeks. Group A will engage in Feldenkrais exercises targeting pelvic and lower limb mobility, while Group B will receive standard treatments including knee isometrics, mobilization, transcutaneous electric nerve stimulation, and heating pad applications. Pain severity will be measured using the Numeric Pain Rating Scale, Range of Motion assessed via goniometry, and disability evaluated using the Western Ontario McMaster Universities Osteoarthritis Index. Statistical analysis using SPSS will compare outcomes between groups at baseline, post-treatment, and follow-up assessments.",[28],[510,511,512,27,513,514],"Disability","Feldenkrais Method","Goniometry","Numeric Pain Rating Scale","Range of Motion","2025-03-10",{"date":517,"type":36},"2025-03-13",{"date":519,"type":36},"2025-01-02",{"date":521,"type":21},"2025-09-15",{"name":523,"class":43},"Riphah International University",{"id":525,"slug":526,"hasResults":11,"nctId":527,"briefTitle":528,"officialTitle":528,"acronym":529,"eligibilityCriteria":530,"healthyVolunteers":141,"sex":166,"minAge":318,"maxAge":18,"enrollmentInfo":531,"targetDuration":4,"studyType":22,"phases":532,"briefSummary":533,"conditions":534,"keywords":535,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":543,"locationsCount":4},"100583002","muscle-isometric-contraction-for-the-treatment-of-knee-osteoarthritis-100583002","NCT06870656","Muscle Isometric Contraction for the Treatment of Knee Osteoarthritis","KOA","Inclusion Criteria:\n\n* Women aged 60 to 80 years;\n* Based on the diagnostic criteria for knee osteoarthritis (KOA) established by the American College of Rheumatology in 2001, participants with KOA graded 1 to 3 were selected;\n* Compliance with the Declaration of Helsinki and signing of the informed consent form.\n\nExclusion Criteria:\n\n* Cardiovascular diseases;\n* Need for surgery or pharmacological treatment in the near future;\n* Neuromuscular diseases;\n* Currently engaged in regular exercise.",{"count":143,"type":21},[24],"This study compares the effects of three different intensities of Muscle Isometric Contraction (MIC) on balance ability, proprioception, muscle strength, KOA symptoms, and inflammatory factors in synovial fluid among elderly individuals with Knee Osteoarthritis (KOA).",[28],[529,536],"Muscle isometric contraction","2025-03-06",{"date":539,"type":36},"2025-03-11",{"date":541,"type":21},"2025-09-20",{"date":541,"type":21},{"name":544,"class":43},"Chengdu Sport University",{"id":546,"slug":547,"hasResults":11,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":318,"enrollmentInfo":552,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":555,"conditions":556,"keywords":557,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":567,"locationsCount":105},"100578724","reflexology-and-mulligan-mobilization-for-knee-osteoarthritis-100578724","NCT06815016","Reflexology and Mulligan Mobilization for Knee Osteoarthritis","The Effect of Adding Reflexology to Mulligan Mobilization for Patient With Knee Osteoarthritis","Inclusion Criteria:\n\n1. Age greater than or equal to 40 years.\n2. Body Mass Index ≤30 kg\u002Fm².\n3. All participants have Calcium Deficiency\n4. Osteoarthritis in mild and moderate stage not in the acute stage\n5. The subjects were chosen from both genders\n\nExclusion Criteria:\n\n1. Deep Vein Thrombosis\n2. Fractures\n3. Gangrena Patient\n4. Osteopenic Patient\n5. Lactating or pregnant women\n6. Cancer\n7. Neurological conditions.\n8. Patients with injury including; (lesions, sprain, open wounds, foot ulcer and or burn of the lower extremities), hemorrhage, epilepsy, irregular heartbeat.\n9. Vascular (Anticoagulant Therapy, Aortic Aneurysm)\n10. Neurological Deficits (multilevel PIVD, Cervical Myelopathy)\n11. Psychological Disorders.\n\n    \\-",{"count":553,"type":21},84,[24],"to investigate the effect of adding Reflexlogy to mulligan mobilization and the conventional treatment for patients with Osteoarthritis knees",[27,28],[558,559,560],"Knee Osteoarthristis","reflexology","Mulligan&amp;#39;s Mobilization","2025-02-03",{"date":563,"type":36},"2025-02-07",{"date":565,"type":21},"2025-02-20",{"date":154,"type":21},{"name":568,"class":43},"Cairo University",{"id":570,"slug":571,"hasResults":11,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":576,"targetDuration":4,"studyType":22,"phases":577,"briefSummary":579,"conditions":580,"keywords":581,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":4},"100567943","phase-4-efficacy-and-safety-of-tongren-dahuoluo-bolus-in-patients-with-knee-osteoarthritis-100567943","NCT06674759","Efficacy and Safety of Tongren-Dahuoluo Bolus in Patients with Knee Osteoarthritis","Efficacy and Safety of Tongren-Dahuoluo Bolus in Patients with Knee Osteoarthritis: a Randomized, Double-blind, Placebo-controlled Clinical Study","Inclusion Criteria:\n\n1. Male or female, aged 40 to 75 years old;\n2. Meet the diagnostic criteria for primary knee osteoarthritis (KOA) (the diagnostic criteria refer to the 1995 American College of Rheumatology classification criteria for knee osteoarthritis);\n3. Meet the diagnostic criteria for liver and kidney deficiency and (or) cold and dampness obstruction in the group standard of the Chinese Association of Traditional Chinese Medicine \"Guidelines for Combination of Osteoarthritis Symptoms\";\n4. X-ray examination of the joints is graded as I to III (knee joint Kellgren\u002FLawrence e scoring standard);\n5. Knee pain score ≥40mm in the past week (assessed by VAS standard);\n\nExclusion Criteria:\n\n1. Patients with other rheumatic diseases such as Sjögren's syndrome, gout, rheumatoid arthritis, or a history of human immunodeficiency virus (HIV);\n2. Patients with severe lesions of important organs such as the heart, liver, and kidney, abnormal liver function (alanine or aspartate aminotransferase or glutamine transpeptidase\\>1.5 times the upper limit of normal value); or abnormal renal function (serum creatinine level\\> upper limit of normal value); white blood cell (white blood cell, WBC) or platelet (platelet, PLT) below the lower limit of normal value; or diabetic patients with poor blood sugar control in the recent period (glycosylated hemoglobin\\>8.0%);\n3. Patients with suppurative, nonspecific, and other infectious knee arthritis;\n4. Patients with traumatic, villonodular pigmentation and other lesions with knee synovium as the main lesions;\n5. Patients with advanced joint deformity or disability; A randomized controlled study on Tongren Dahuoluowan in the treatment of knee osteoarthritis Version number: 2023009P8A01 Version date: December 23, 2022\n6. Allergic constitution and allergic to the test drug;\n7. Pregnant, pregnant, or lactating women;\n8. Those who are taking antidepressants, anticonvulsants, opioids, sedatives and glucocorticoids;\n9. Patients who have received intra-articular treatment with sodium hyaluronate within 4 weeks before screening; those who have taken drugs containing chondroitin sulfate\u002Fglucosamine\u002Fdiacerein within 3 months before screening; those who have used biological agents within 3 months before screening;\n10. Patients with organ failure symptoms;\n11. Those who have participated in any other drug trials within 1 month before selection;\n12. Those who the researcher believes are not eligible to join this clinical trial",{"count":54,"type":21},[578],"PHASE4","The clinical trial has a research cycle of 24 weeks. The first 12 weeks are multicenter, randomized, double-blind, controlled trials. A total of 72 patients with knee osteoarthritis with liver-kidney deficiency syndrome and\u002For cold-dampness arthralgia syndrome are planned to be enrolled and randomly assigned to the control group (Tongren-Dahuoluo Bolus) and the treatment group (Tongren-Dahuoluo Bolus Placebo) in a 1:1 ratio. The purpose is to compare the safety and efficacy of Tongren-Dahuoluo Bolus and placebo in treating knee osteoarthritis. A long-term blind extension study will be conducted in the next 12 weeks. All subjects will take Tongren-Dahuoluo Bolus orally to evaluate the long-term safety, tolerability, and efficacy of Tongren-Dahuoluo Pills in treating patients with knee osteoarthritis.",[28],[582,583],"Tongren-Dahuoluo Bolus","Knee osteoarthritis (Knee OA)","2024-11-03",{"date":586,"type":36},"2024-11-05",{"date":588,"type":21},"2025-01-10",{"date":590,"type":21},"2025-12-30",{"name":592,"class":43},"Guang'anmen Hospital of China Academy of Chinese Medical Sciences"]