[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659756":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":38,"studyPopulation":29,"armGroups":39,"interventions":53,"overallOfficials":72,"centralContacts":77,"locations":86,"responsibleParty":102,"collaborators":29,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":29,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":128,"overallStatus":133,"whyStopped":29,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Gaziler Physical Medicine and Rehabilitation Education and Research Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":29},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score","WOMAC is a self-administered questionnaire evaluating pain, stiffness, and physical function in knee osteoarthritis. Total score ranges from 0 to 96, where higher scores indicate worse pain, stiffness, and functional limitation.","Baseline, Week 2, Week 4, and Week 12 post-injection",{"measure":14,"description":15,"timeFrame":12},"Change in Visual Analog Scale (VAS) Pain Score","VAS measures pain intensity during activity on a 10-cm\u002F100-mm continuous line (0 = no pain, 100 = worst imaginable pain). Higher scores indicate greater pain severity.",[17,21,25],{"measure":18,"description":19,"timeFrame":20},"Change in Short Form-36 (SF-36) Health Survey Score","SF-36 evaluates health-related quality of life across 8 domains (Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health), yielding Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Scores range from 0 to 100, where higher scores represent better health status\u002Fquality of life.","Baseline, Week 4, and Week 12 post-injection",{"measure":22,"description":23,"timeFrame":24},"Global Perceived Effect (GPE) Scale Score","GPE measures the patient's subjective perception of overall treatment response and improvement on a 7-point Likert scale ranging from 1 ('vastly improved') to 7 ('vastly worsened'). Lower scores indicate greater treatment satisfaction and recovery.","Week 2, Week 4, and Week 12 post-injection",{"measure":26,"description":27,"timeFrame":28},"Rescue Analgesic Consumption and Adverse Events","Total amount of rescue analgesic (paracetamol) consumed by participants (recorded via patient diaries in grams) and the incidence\u002Fseverity of any local or systemic adverse events related to the procedures or injected medications.","Up to 12 weeks post-injection",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":29,"timePerspective":29,"maskingInfo":35},"RANDOMIZED","PARALLEL","This is a single-center, prospective, randomized, open-label, active-controlled trial with two parallel assignment arms (1:1 allocation ratio). Block randomization with a block size of 4 will be used to assign 60 patients into two intervention groups:\n\n1. Group 1 (Active Control): US-guided intra-articular corticosteroid injection + home exercises (n=30).\n2. Group 2 (Intervention): US-guided intra-articular corticosteroid injection + US-guided high-volume saphenous nerve block + home exercises (n=30).","TREATMENT",{"masking":36,"maskingDescription":37,"whoMasked":29},"NONE","Due to differences in anatomical injection sites and techniques between groups, blinding of participants and the administering physician was not feasible. To minimize potential assessment bias, outcome measures (WOMAC, VAS, SF-36) will be completed independently by the participants as self-reported questionnaires without investigator guidance.","Knee osteoarthritis (OA) is a progressive degenerative joint disorder characterized by chronic pain and functional limitation. Beyond cartilage loss, peripheral sensitization and neuroinflammatory mechanisms play crucial roles, particularly in advanced stages (Kellgren-Lawrence Grade 3-4). The saphenous nerve provides essential sensory innervation to the medial and anteromedial knee joint. Combining US-guided intra-articular corticosteroid injection with a high-volume perineural saphenous nerve block is hypothesized to suppress peripheral nociceptive transmission and promote mechanical hydrodissection of perineural adhesions, offering enhanced pain relief and functional restoration.\n\nSTUDY DESIGN AND RANDOMIZATION:\n\nThis single-center, prospective, randomized, open-label, active-controlled study will enroll 60 patients aged 45-75 years with primary medial compartment knee OA (KL grade 3-4) refractory to conservative therapy for at least 3 months. Block randomization (block size of 4) will allocate patients into two equal groups (n=30 per group).\n\nINTERVENTIONS:\n\n1. Group 1 (IA Corticosteroid): Patients will receive a US-guided intra-articular injection of 40 mg (1 mL) triamcinolone acetonide mixed with 1 mL 0.9% saline (total volume: 2 mL) via a suprapatellar lateral approach using an in-plane technique.\n2. Group 2 (IA Corticosteroid + High-Volume Saphenous Nerve Block): Patients will receive the same IA corticosteroid injection as Group 1, followed by a US-guided high-volume saphenous nerve block at the mid-thigh\u002Fadductor canal level. A total of 10 mL bupivacaine solution (\\~0.2% final concentration, prepared with 8 mL 0.25% bupivacaine and 2 mL 0.9% saline) will be injected perineurally around the saphenous nerve with 360-degree circumferential spread.\n\nBoth groups will perform a standardized 4-week home-based exercise program (5 days\u002Fweek, 25-30 min\u002Fday) focusing on muscle strengthening and stretching.\n\nOUTCOME MEASURES:\n\n* Primary Outcome: Functional status change assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at T0, T1 (1st month), T2 (3rd month), and T3 (6th month).\n* Secondary Outcomes:\n\n  1. Pain severity using Visual Analog Scale (VAS at rest and movement) at T0, T1, T2, and T3.\n  2. Health-related quality of life measured by SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS) at T0, T1, T2, and T3.\n  3. Saphenous nerve cross-sectional area (CSA in mm²) measured by continuous trace function at the same anatomical level using zero-pressure technique at T0, T1, and T3.\n  4. Perineural vascularity scored semi-quantitatively (0-3 scale) using Power Doppler US (PRF 500-750 Hz) at T0, T1, and T3.\n\nSTATISTICAL POWER:\n\nSample size was calculated using G\\*Power 3.1.9 based on a 20% MCID in WOMAC pain subscore (effect size d=0.7, alpha=0.05, power=80%), indicating a minimum of 26 patients per group. Factoring in a 15% drop-out rate, 30 patients per group (total N=60) will be recruited.",[40,47],{"label":41,"type":42,"description":43,"interventionNames":44},"Group 1: Intra-articular Corticosteroid Injection","ACTIVE_COMPARATOR","Participants will receive a US-guided intra-articular corticosteroid injection consisting of 40 mg (1 mL) triamcinolone acetonide mixed with 1 mL 0.9% saline (total volume 2 mL) via a suprapatellar lateral approach. Participants will also perform a standardized 4-week home-based exercise program.",[45,46],"Drug: Intra-articular corticosteroid injection","Other: Home-Based Exercise Program",{"label":48,"type":49,"description":50,"interventionNames":51},"Group 2: Intra-articular Corticosteroid + High-Volume Saphenous Nerve Block","EXPERIMENTAL","Participants will receive a US-guided intra-articular corticosteroid injection (40 mg triamcinolone acetonide + 1 mL 0.9% saline, total 2 mL) combined with a US-guided high-volume saphenous nerve block (10 mL bupivacaine solution, \\~0.2% final concentration, prepared with 8 mL 0.25% bupivacaine and 2 mL 0.9% saline) at the adductor canal\u002Fmid-thigh level. Participants will also perform a standardized 4-week home-based exercise program.",[45,52,46],"Procedure: Ultrasound-Guided High-Volume Saphenous Nerve Block",[54,61,68],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"DRUG","Intra-articular corticosteroid injection","Ultrasound-guided intra-articular injection of 40 mg (1 mL) triamcinolone acetonide mixed with 1 mL 0.9% saline (total volume 2 mL) into the knee joint via a suprapatellar lateral approach.",[41,48],[60],"Triamcinolone acetonide, Kenacort",{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"PROCEDURE","Ultrasound-Guided High-Volume Saphenous Nerve Block","Ultrasound-guided high-volume saphenous nerve block administered at the adductor canal\u002Fmid-thigh level using 10 mL bupivacaine solution (\\~0.2% final concentration, prepared with 8 mL 0.25% bupivacaine and 2 mL 0.9% saline).",[48],[67],"Adductor Canal Block, Saphenous Nerve Hydrodissection, Bupivacaine",{"type":6,"name":69,"description":70,"armGroupLabels":71,"otherNames":29},"Home-Based Exercise Program","Standardized 4-week home-based knee osteoarthritis exercise routine, including range of motion, isometric quadriceps, and lower extremity stretching exercises.",[41,48],[73],{"name":74,"affiliation":75,"role":76},"SEFA GUMRUK ASLAN, Assoc.Prof.","Ankara Gaziler Physical Medicine and Rehabilitation Training and Research Hospital","PRINCIPAL_INVESTIGATOR",[78,82],{"name":74,"role":79,"phone":80,"phoneExt":29,"email":81},"CONTACT","+90 531 983 14 06","sefagumrukk@gmail.com",{"name":83,"role":79,"phone":84,"phoneExt":29,"email":85},"MUHAMMET EMİR ACAR, MD","+90 545 387 61 40","muh.emiracar@gmail.com",[87],{"facility":75,"status":29,"city":88,"state":29,"zip":89,"country":90,"countryCode":29,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Ankara","06800","Turkey (Türkiye)",{"type":92,"coordinates":93},"Point",[94,95],32.85427,39.91987,{"lat":95,"lon":94},[98,100,101],{"name":99,"role":79,"phone":84,"phoneExt":29,"email":85},"MUHAMMET EMIR ACAR, MD",{"name":74,"role":79,"phone":80,"phoneExt":29,"email":81},{"name":74,"role":76,"phone":29,"phoneExt":29,"email":29},{"type":76,"investigatorFullName":103,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Sefa Gümrük Aslan","Assistant professor","100659756","us-guided-saphenous-block-in-knee-oa-100659756",false,"NCT07868770","US-Guided Saphenous Block in Knee OA","Evaluation of the Clinical and Sonographic Effects of Ultrasound-Guided Saphenous Nerve Block in Knee Osteoarthritis","SAPH-KNEE-OA","Inclusion Criteria:\n\n* Patients aged between 40 and 75 years\n* Diagnosis of primary knee osteoarthritis according to the American College of Rheumatology (ACR) criteria\n* Kellgren-Lawrence grade 2 or 3 knee osteoarthritis on weight-bearing radiographs\n* Moderate to severe knee pain (Visual Analog Scale score ≥ 4\u002F10) lasting for at least 3 months\n* Willingness and ability to participate in the study and sign the written informed consent form\n\nExclusion Criteria:\n\n* Kellgren-Lawrence grade 1 or grade 4 knee osteoarthritis\n* History of intra-articular corticosteroid injection in the target knee within the past 3 months\n* History of intra-articular hyaluronic acid or platelet-rich plasma (PRP) injection in the target knee within the past 6 months\n* Previous knee surgery or arthroplasty on the target knee\n* Secondary knee osteoarthritis (e.g., post-traumatic, inflammatory arthritis, gout, septic arthritis)\n* Severe systemic diseases, active infection, or localized skin infection at the injection site\n* Coagulopathy or ongoing anticoagulant therapy\n* Known allergy or hypersensitivity to local anesthetics, triamcinolone acetonide, or bupivacaine\n* Severe cognitive impairment or inability to comply with follow-up protocols and home exercises","ALL","40 Years","75 Years",{"count":117,"type":118},60,"ESTIMATED","INTERVENTIONAL",[121],"NA","The purpose of this prospective, randomized, open-label, active-controlled clinical trial is to evaluate the clinical and sonographic effects of ultrasound-guided (US-guided) high-volume saphenous nerve block combined with intra-articular corticosteroid injection compared to intra-articular corticosteroid injection alone in patients with Kellgren-Lawrence Grade 3-4 medial compartment knee osteoarthritis (OA) refractory to conservative treatment.\n\nA total of 60 participants aged 45-75 years will be randomly assigned (1:1) into two treatment arms:\n\n* Group 1: US-guided intra-articular corticosteroid injection (40 mg triamcinolone acetonide + 1 mL saline) + home exercise program.\n* Group 2: US-guided intra-articular corticosteroid injection + US-guided high-volume saphenous nerve block (10 mL 0.2% bupivacaine solution) + home exercise program.\n\nClinical assessments (WOMAC, VAS, and SF-36) will be conducted at baseline (T0), 1st month (T1), 3rd month (T2), and 6th month (T3). Sonographic evaluations, including saphenous nerve cross-sectional area (CSA) and perineural vascularity via Power Doppler US, will be performed at baseline (T0), 1st month (T1), and 6th month (T3). The primary outcome is functional improvement measured by the change in WOMAC total score.",[124,125,126,127],"Knee Osteoarthritis","Osteoarthritis, Knee","Gonarthrosis","Knee Pain",[129,130,131,132],"Saphenous Nerve Block","Nerve Hydrodissection","Adductor Canal Block","Ultrasound-Guided Injection","NOT_YET_RECRUITING","2026-10-07",{"date":136,"type":137},"2026-10-09","ACTUAL",{"date":139,"type":118},"2026-10-02",{"date":141,"type":118},"2027-11-30",{"name":5,"class":6},1]