[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"synovitis-of-knee\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:synovitis-of-knee":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,82,111],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100610303","phase-2-a-trial-to-investigate-the-safety-and-efficacy-of-intra-articular-4p004-injection-in-subjects-with-knee-synovitis-and-osteoarthritis-100610303",false,"NCT07225829","A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritis","A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof of Concept Trial to Investigate the Efficacy and Safety of Intra-articular 4P004 in Subjects With Knee Synovitis and Osteoarthritis","INFLAM MOTION","Inclusion Criteria:\n\n* Participants who have the capacity to give informed consent and who are willing to comply with all trial related procedures and assessments.\n* Participants between 40 and 80 years of age.\n* Female participant of childbearing potential (defined as any woman unless postmenopausal for at least one year or surgically sterile) must use highly effective methods of contraception as defined in the protocol. Highly effective contraceptive measures must be continued throughout the trial until the final visit.\n* Bodyweight \\> 40 kg.\n* Body mass index (BMI) ≥ 18.5 and ≤ 35.\n* Ambulatory (single assistive devices such as canes allowed).\n* Widespread Pain Index (WPI) ≤ 4.\n* Pain NRS (0-10) \\\u003C 4 in the contralateral knee.\n* History of OA-related pain of the TK for at least 6 months.\n* Moderate to severe pain of the TK the majority of days during the last 3 months as per participant's judgement.\n* Moderate to severe pain of the TK on the WOMAC Pain subscale prior to the Randomization visit (V2) complying with: a) Complete WOMAC Pain diary for at least 7 of the last 10 days prior to V2 (including V2\u002FD1 rating which is mandatory), and b) Diary reported WOMAC Pain between 5 and 9 for at least 7 of the last 10 days.\n* History of insufficient pain relief, intolerance, or contraindication to NSAIDs, and at least a history of insufficient pain relief from at least one of the following therapies: a) Acetaminophen\u002Fparacetamol, b) Opioids including tramadol, or c) Corticosteroids, hyaluronate IA injections (efficacy less than 3 months according to the patient).\n* KL grade 2 to 4 on the Schuss radiograph.\n* Predominant femorotibial OA based on the OA Research Society International. (OARSI) Atlas reading (Altman \\& Gold, 2007).\n* Presence of synovitis in the TK assessed locally using PDUS, and synovial thickness of ≥ 5 mm evaluated through a longitudinal view of the suprapatellar pouch and axial views of the medial and lateral patellofemoral pouches.\n* Negative urine drug screen (performed locally): amphetamines, barbiturates, cocaine.\n* CE-MRI Central reading to confirm synovitis with a synovial Semi-Quantitative (SQ) ≥ 9 or a SQ score ≥7 with at least one site with a score ≥ 2.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the TK (varus \\> 10°, valgus \\> 10°) by radiography.\n* Secondary OA such as joint dysplasia, aseptic osteonecrosis, joint infection, acromegaly, Paget disease, hemochromatosis, joint crystal disease or any inflammatory joint disease.\n* Any known active infections including skin infections at the site injection or increased predisposition for the development of infections.\n* Any partial knee replacement of the TK.\n* Acute fracture or IA trauma to the TK within 12 months prior to the screening visit.\n* Major knee surgery performed within the previous 12 months or planned during the trial.\n* Arthroscopy of the TK within 6 months prior to the screening visit.\n* Presence of any painful conditions that could confound accurate assessment of pain from OA in the TK, such as fibromyalgia, peripheral neuropathy or vascular insufficiency.\n* Treatment with systemic corticosteroids (other than IA) at a dose greater than 10 mg prednisone or the equivalent per day for more than 7 days within 4 weeks prior to the screening visit.\n* Treatment of the TK with any IA injection (including corticosteroids, hyaluronic acid derivatives, Platelet Rich Plasma….) within 24 weeks prior to the screening visit.\n* Any treatment with glucosamine, chondroitin sulfate, or other nutraceuticals with potential activity on OA within the previous 3 months prior to the screening visit.\n* Treatment with duloxetine for OA (allowed if given for depressive disorders at stable dose since at least 3 months before V1).\n* Any significant psychiatric illness unless well controlled since at least 6 months.\n* Current treatment with combination of insulin and liraglutide (Xultophy®) or with GLP-1 agonist administered once a week (semaglutide, dulaglutide).\n* High-risk of bleeding.\n* Congestive Heart Failure stage III or IV in the New York Heart Association classification.\n* History or current diagnosis of electrocardiogram ECG abnormalities indicating significant safety risk (such as ischemia, significant cardiac arrhythmias).\n* Glycemia \\\u003C 4.4 mmol\u002FL (or 80 mg\u002FdL) at screening.\n* Clinically significant abnormal laboratory test at screening, in particular: haemoglobin \\\u003C10 g\u002FdL, white blood cell \\\u003C3000\u002FµL (3.0 Giga\u002FL), absolute neutrophil count \\\u003C1000\u002FµL (1.0 Giga\u002FL), platelets count \\\u003C100,000\u002FµL (100 Giga\u002FL), alanine aminotransferase or aspartate aminotransferase \\>2.5 upper limit of normal (ULN), total bilirubin \\>1.5 ULN, lipasemia \\>1 ULN.\n* Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m2, using Chronic Kidney Disease - EPIdemiology (CKD EPI) 2021 Formula.\n* Any other abnormal laboratory results that the Investigator believes should preclude the subject's participation in the trial.\n* History of hypersensitivity to IMP or excipients (liraglutide or disodium phosphate dihydrate, propylene glycol, phenol).\n* Any contraindication for MRI (cardiac pacemaker, deep brain stimulators, intraocular metal, cerebral aneurysm clips, recent stents, cochlear implants, neurostimulators and implantable pumps) or inability to undergo MRI (e.g., body size, leg not fitting in the coil, claustrophobia).\n* History of hypersensitivity reactions to a gadolinium-based contrast agent.\n* Any CE-MRI Central reading additional diagnoses: posterior meniscal root tears, subchondral insufficiency fractures, osteonecrosis, malignant bone marrow infiltration, solid tumours, and traumatic fracture or bone bruise using ROAMES (Roemer et al., 2020).\n* Previous participation in clinical research with a disease-modifying OA drug during the last 2 years.\n* Participation in an interventional clinical research trial within 3 months before screening.\n* Participants who, in the investigator's judgement, are at risk of falling.\n* Participants with a history, or current diagnosis, of pancreatitis, thyroid cancer (including medullary thyroid carcinoma), multiple endocrine neoplasia type-2 (MEN2), diabetic ketoacidosis, type-1 diabetes mellitus (T1DM), inflammatory bowel disease, or diabetic gastroparesis.\n* Participants currently, or within the last 10 days, taking any anticoagulant treatment.","ALL","40 Years","80 Years",{"count":21,"type":22},129,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This phase 2a trial is an international, multicenter, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of one single intra-articular (IA) injection of 4P004 or placebo in:\n\n* patients between 40 and 80 years of age,\n* with synovitis and grade 2 to 4 osteoarthritis (OA) of the knee according to Kellgren and Lawrence (KL) classification.",[28,29],"Knee Osteoarthritis","Synovitis of Knee",[31,32,33,34],"OA","Knee OA","Liraglutide","Osteoarthritis","RECRUITING","2026-04-10",{"date":38,"type":39},"2026-04-14","ACTUAL",{"date":41,"type":39},"2025-06-17",{"date":43,"type":22},"2026-09",{"name":45,"class":46},"4Moving Biotech","INDUSTRY",22,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100597328","light-therapy-on-pain-and-synovitis-100597328","NCT07057063","Light Therapy on Pain and Synovitis","Effect of Light Therapy on Pain and Synovitis in Patients With Knee Synovitis: Study Protocol for a Randomized Controlled Trial","Inclusion Criteria:\n\n* Participants aged between 40 and 80 years\n* Able to provide written informed consent\n* Have experienced knee pain that persists or recurs for more than 3 months\n* A knee pain score of at least 30 mm on the 100-mm Visual Analogue Scale (VAS) during the past week\n* Ultrasound-measured knee synovitis ≥1\n* Presence of knee OA according to criteria established by the American College of Rheumatology\n\nExclusion Criteria:\n\n* Anticipated need for knee surgery within the next one year\n* Previous or planned knee replacement within the next one year\n* Knee surgery or other physical therapy in the previous 3 months\n* Use of intra-articular, intra-muscular, or oral corticosteroids in previous 4 weeks\n* Malignant tumors or other life-threatening diseases\n* Severe mental disorders, including but not limited to schizophrenia, bipolar disorder, or major depressive disorder, that may interfere with the participant's ability to comply with the study protocol or provide informed consent",{"count":56,"type":22},80,[58],"NA","Background: Knee pain is a common complaint among middle-aged and older adults, often leading to reduced mobility and diminished quality of life. Synovitis is a major underlying cause, present in up to 80% of individuals with moderate knee pain. While light therapy has shown anti-inflammatory and analgesic effects in preclinical studies, our prior animal experiments revealed that light therapy at 810 nm significantly alleviated inflammation and pain-like behaviors. These findings suggest a potential wavelength-specific therapeutic effects. However, it remains unclear whether such effects can be replicated in humans. This study aims to evaluate the efficacy of 810 nm light therapy, compared to sham treatment, in reducing knee pain and synovitis in patients with chronic knee pain and knee synovitis.\n\nMethods\u002Fdesign:\n\nThis is a randomized, placebo-controlled clinical trial involving 90 participants with chronic knee pain and ultrasound-detected synovitis. Participants will be randomized into two groups to receive 810 nm light therapy, or sham therapy, delivered twice weekly over five weeks. Primary outcomes include knee pain assessed by the Visual Analogue Scale (VAS) and synovitis assessed by ultrasound. Secondary outcomes include the Knee injury and Osteoarthritis Outcome Score (KOOS), the 30-second chair stand test, and the 40-meter fast-paced walk test. Outcome assessments will be performed at baseline, post-intervention (week 5), and at 1 month and 6 months after treatment completion. Linear mixed-effects models will be used to compare outcome changes between groups.\n\nDiscussion:\n\nThis trial will assess whether 810 nm light therapy provides clinically meaningful benefits for reducing knee pain and synovitis in humans, building on promising preclinical findings. Results from this study may support the use of near-infrared light as a safe, non-invasive, and effective intervention for synovitis-related knee pain.",[61,29,62],"Knee Pain Chronic","Light Therapy",[64,65,66,67,68,69,70],"Light therapy","Photobiomodulation","Chronic knee pain","Synovitis","Randomized controlled trial","Non-pharmacological intervention","physical therapy","2025-11-19",{"date":73,"type":39},"2025-11-26",{"date":75,"type":39},"2025-07-13",{"date":77,"type":22},"2026-05-28",{"name":79,"class":80},"The Hong Kong Polytechnic University","OTHER",2,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100605347","phase-2-role-of-methotrexate-in-ultrasound-proven-synovitis-in-primary-knee-oa-100605347","NCT07161336","Role of Methotrexate in Ultrasound Proven Synovitis in Primary Knee OA","Role of Methotrexate in Ultrasound Proven Synovitis in Patients With Knee Osteoarthritis : A Randomized Controlled Trial","MTX in knee OA","Inclusion Criteria:\n\n* Men and women aged between 40 to 70 years\n* Patients fulfilling American College of Rheumatology (ACR) clinical and radiological criteria for knee OA. (knee pain + at least 3 of 5 that not including \"no palpable warmth\")\n* Knee pain on most days for at least 6 months, with a pain VAS of at least 40mm\n* Radiological grading of OA with Kallgren-Lawrence grade of 2 to 3\n* Patients with the presence of knee synovitis in Musculoskeletal ultrasound\n\nExclusion Criteria:\n\n* Any known inflammatory arthritis\n* BMI \\>= 40 kg\u002Fm2\n* Abnormal renal (e.g. abnormal renal function Creatinine clearance \\\u003C35 ml) hepatic (including active hepatitis B, hepatitis C, abnormal liver function), hematological (e.g. white cell count \\\u003C 4 × 109\u002FL, platelets \\\u003C100 ×109\u002FL, or hemoglobin \\\u003C 9 g\u002FdL), function\n* Use of intra-articular, intramuscular or oral corticosteroids in previous 4 weeks\n* History knee joint surgery, Charcot joint\n* Severe valgus knee deformity (angle of genu valgum \\> 30°)\n* Use of any disease modifying agents (e.g. hydroxychloroquine or sulfasalazine) in previous 3 months\n* Allergic to MTX\n* Pregnant or lactating women","70 Years",{"count":92,"type":22},70,[25],"Background:\n\nOsteoarthritis (OA) is a leading cause of disability worldwide, with limited treatment options and many patients suffering from chronic pain. Modern imaging has revealed that OA involves complex changes in cartilage, subchondral bone, and synovium. Pain in OA is often linked to synovitis, which is common in the condition. Methotrexate (MTX), a proven treatment for synovitis in inflammatory arthritis like rheumatoid arthritis and has a well-known safety profile. The proposal suggests that using MTX may have potential to treat symptomatic knee OA with USG (musculoskeletal ultrasound) proven synovitis by reducing synovitis and as a result, alleviate pain.\n\nObjectives:\n\nTo assess the role of methotrexate in primary knee osteoarthritis associated with ultrasound proven synovitis.\n\nMethods:\n\nThis randomized Controlled trial will be conducted in the department of Rheumatology, Bangladesh Medical University (BMU) from July 2025 to June 2026. A total of 70 patients will be enrolled with primary knee OA diagnosed on the basis of ACR Criteria for Knee OA with informed written consent. MSK USG examinations of knee joint and scoring (OMERACT SCORE) will be performed to detect synovitis by a rheumatologist expert in MSK US. Then randomization will be done into group A and group B following a randomization table, each consisting of 35 patients. Consecutive sampling techniques will be followed. One group will receive MTX (start with 15 mg per week for the first 2 weeks then increase to 20 mg and continue for the remaining period if tolerated) and Both groups of patients will be allowed to take NSAIDs on a requirement basis with documentation and follow non-pharmacological treatment of OA. At the end of 3rd and 6th month pain and functional status will be assessed by WOMAC, VAS and quality of life will be assessed by using Bangla version of SF-12. At the end of 6th month improvement of synovitis will be seen by MSK USG of involved knees with OMERACT scoring. Primary endpoint for efficacy will be assessed at the end of 24th week by WOMAC. Secondary endpoints will be determined by VAS and SF-12. Adverse effects will be assessed by history, physical examinations and investigations. The data will be analyzed by using the latest version SPSS software (Version 29). Results will be recorded using means and standard deviations. Results will be compared among two groups with a 95% confidence interval and a p- value of \\\u003C 0.05 will be considered statistically significant. The degrees of statistical significance between groups will be analyzed by unpaired t test (for quantitative normally distributed data) and Mann Whitney U test if there is skewed distribution. Qualitative data in between groups will be analyzed by the chi square test. Probabilities of associations will be assessed by calculating Pearson's rank correlation coefficient. P-value \\\u003C0.05 will be regarded as statistically significant. The nature, purpose and implication of the study as well as the entire spectrum of benefits and risks of study will be explained to the patients. Privacy and confidentiality of the subject will be maintained. Each patient will enjoy the right to participate and or withdraw from the study at any point of the study period. Ethical clearance will be obtained from the institutional Review Board (IRB) of BMU.",[96,29,97],"Osteo Arthritis of the Knee","Methotrexate",[99,100,97],"knee OA","synovitis","2025-09-07",{"date":103,"type":39},"2025-09-12",{"date":105,"type":39},"2025-07-30",{"date":107,"type":22},"2026-08-30",{"name":109,"class":80},"Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh",1,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":119,"maxAge":19,"enrollmentInfo":120,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":123,"conditions":124,"keywords":130,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":110},"100493094","perfusion-mri-targeted-joint-embolization-for-chronic-musculoskeletal-pain-of-the-shoulder-hip-and-knee-100493094","NCT05700682","Perfusion MRI-targeted Joint Embolization for Chronic Musculoskeletal Pain of the Shoulder, Hip and Knee","Perfusion MRI-targeted Joint Embolization to Diagnose and Treat Neovascularity Associated With Chronic Musculoskeletal Pain of the Shoulder, Hip and Knee: A Prospective Cohort Study","MRI","Inclusion Criteria (Both Arms):\n\n1. Participants must be Veterans who receive care in the VA system.\n2. Participants must have a history of chronic pain of the shoulder, hip or knee for at least 1 year.\n3. Participants must have mild to moderate degenerative changes of the painful joint as depicted on prior imaging (X-ray, CT or MRI).\n4. Participants must have undergone at least one failed primary treatment for their chronic pain (e.g. physical therapy, NSAIDs, steroid injection).\n5. Participants must have an MRI of their painful joint (shoulder, hip or knee) ordered by a clinical provider.\n\nInclusion Criteria (Therapeutic Arm):\n\n1. Participants must have enrolled in the Diagnostic Arm of the study and must have undergone perfusion MR imaging of their painful joint.\n2. Participants must have evidence of peri-articular hypervascularity on their perfusion MR exams. This will be determined by the study PIs.\n\nExclusion Criteria (Diagnostic Arm):\n\n1. Acute injury in the last 12 weeks.\n2. Age under 25.\n3. Severe degenerative changes of painful joint (shoulder, hip or knee).\n4. History of arthroplasty or metallic implant within the painful joint.\n5. Severe gadolinium contrast allergy.\n6. Severe renal disease or ongoing dialysis.\n7. History of malignancy with life expectancy of less than one year, or malignancy with known bone metastasis.\n8. Current pregnancy.\n9. Formal diagnosis of cognitive impairment.\n\nExclusion Criteria (Therapeutic Arm):\n\n1. Severe iodinated contrast allergy.\n2. Severe coronary or peripheral arterial disease.\n3. Coagulopathy.\n4. Uncontrolled type 2 diabetes or diabetic neuropathy.\n5. History of seizures or other severe complication from conscious sedation.\n6. Prior upper or lower extremity arterial bypass.\n7. Ongoing participation in another interventional (therapeutic) trial for chronic joint pain.\n8. Lack of peri-articular hypervascularity on initial perfusion MRI.\n9. All exclusion criteria for the Diagnostic Arm.","25 Years",{"count":121,"type":22},120,"OBSERVATIONAL","In this work the investigators will study the relationship between chronic musculoskeletal pain and abnormal blood flow (neovascularity) around the shoulder, hip and knee. Veterans with as history of chronic shoulder, hip or knee pain and mild\u002Fmoderate joint degenerative changes will be potential study subjects. Blood flow around joints will be evaluated using perfusion magnetic resonance imaging (MRI). Participants with demonstrably abnormal blood flow around their painful joint will be eligible for enrollment in a pilot study of joint embolization to treat their pain. Participants who choose to not undergo treatment will be re-assessed with MRI after one year to characterize the natural history of joint neovascularity and its relationship to pain.",[125,126,127,29,128,67,129],"Osteoarthritis, Knee","Osteoarthritis, Hip","Osteo Arthritis Shoulders","Synovitis\u002FTenosynovitis - Hip","Pain, Chronic",[131,132,133,134,135,136,137],"joint","embolization","neovascularity","pain","knee","hip","shoulder","2025-08-04",{"date":140,"type":39},"2025-08-07",{"date":142,"type":39},"2023-07-15",{"date":144,"type":22},"2026-08-01",{"name":146,"class":80},"Palo Alto Veterans Institute for Research"]