[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07020897":3,"trial-entities:NCT07020897":112,"trial-summary:NCT07020897":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":45,"secondary_outcomes":50,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":14,"eligibility_criteria":60,"std_ages":77,"locations":80,"central_contacts":105,"overall_officials":107,"references":110,"see_also_links":111},"NCT07020897","IRB-FY2025-156","Short-term and Intermediate-term Effects of Self-applied Joint Mobilization Versus Clinician-applied Joint Mobilization in Addition to Exercise in Patients With Knee Osteoarthritis: A Randomized Clinical Trial","NOT_YET_RECRUITING","2026-11-30","2025-04","2025-06-13","2025-07-15","Texas Woman's University","OTHER",false,"The goal of this clinical trial is to learn if a combination of patient self-administered joint mobilization and exercise works to treat knee osteoarthritis in adults. The main questions it aims to answer are:\n\n* Does self-administered joint mobilization improve the ability to perform regular daily activities?\n* Does self-administered joint mobilization improve knee motion?\n* Does self-administered joint mobilization improve hip strength?\n\nResearchers will compare the program of self-administered joint mobilization to a joint mobilization administered by a physical therapist.\n\nParticipants will:\n\n* Attend 8-12 physical therapy clinic visits over 6 - 8 weeks\n* Perform home exercises\n* Visit the clinic 6 months later for a brief check-up","This study will take place in the Outpatient Rehabilitation Clinic at Texas Health Resources (THR) in Plano, or in the Texas Health Sports Medicine Clinic in Allen.\n\nParticipants in this study will be asked to complete the same intake forms and questionnaires as any other physical therapy patient being seen for knee pain at all of the THR physical therapy clinics. These will include questions about health history, learning style, living situation, and goals for physical therapy treatment. One investigator will perform a physical therapy evaluation, including joint motion, muscle strength, and flexibility measurements, as well as functional testing.\n\nFor this study, we will measure one knee motion and one hip strength item and ask participants to complete a knee- specific questionnaire 3 times: on the initial evaluation visit, during the last visit of physical therapy, and during a 6-month follow-up visit.\n\nAfter the initial evaluation visit, we will assign each participant into one of the two treatment groups, self-joint mobilization or joint mobilization performed by a physical therapist. Participants will be asked to attend 7 - 11 physical therapy treatment visits over 7-8 weeks for strength training exercises, flexibility exercises, joint mobilization, and a home exercise program. Each physical therapy visit, including the initial evaluation visit will last 45 minutes. Participants will be asked to track compliance with a home program and attend a follow-up appointment about 6 months after the initial evaluation. This follow-up visit will last about 30 minutes.\n\nAll appointments, except for the 6-month follow-up, will be structured and carried out as they would for any other patient receiving physical therapy for knee pain.",[18],"Knee Osteoarthritis",[20,21,22,23,24],"Knee flexion contracture","Knee osteoarthritis","Joint mobilization","Physical therapy","Hip abductor strength","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},24,"ESTIMATED",[33,37,41],{"type":13,"name":34,"description":35,"armGroupLabels":36},"Clinician-administered joint mobilization","Tibiofemoral arthrokinematic extension joint mobilization and multidirectional patellofemoral mobilization applied by a physical therapist.",[34],{"type":13,"name":38,"description":39,"armGroupLabels":40},"Self-administered joint mobilization","Tibiofemoral arthrokinematic extension joint mobilization and multidirectional patellofemoral mobilization applied by the research participant.",[38],{"type":13,"name":42,"description":43,"armGroupLabels":44},"Exercise-based physical therapy","In-clinic exercise-based physical therapy supervised by a physical therapist, with home exercises to be performed on days without a clinical visit.",[34,38],[46],{"measure":47,"description":48,"timeFrame":49},"Western Ontario and McMaster Universities Arthritis Index (WOMAC)","The WOMAC is a self-administered questionnaire assessing pain, stiffness, and physical function in patients with knee osteoarthritis.","Baseline (enrollment), 6-8 weeks (end of physical therapy sessions), 6 months",[51,53],{"measure":24,"description":52,"timeFrame":49},"Hip abductor strength measured by hand-held dynamometer",{"measure":54,"description":55,"timeFrame":56},"Passive knee extension range of motion","Passive knee extension range of motion will be measured in supine with traditional goniometry and in prone with a heel-height measurement.","Baseline (enrollment), 6-8 weeks (end of in-clinic physical therapy), 6 months","ALL","45 Years",null,{"inclusion":61,"exclusion":69,"raw_text":76},[62,63,64,65,66,67,68],"Meets National Institute for Health and care Excellence (NICE) criteria for knee osteoarthritis:","Age 45 years or older","Movement-related knee pain","No morning stiffness or morning stiffness \\\u003C 30 minutes","Knee flexion contracture (kFC) at least 1cm, measured by heel-height","Fluency in verbal and written English for completion of outcome measure and screening, and to take directions.","Able to attend all study-related appointments",[70,71,72,73,74,75],"Assistive device required for ambulation","Systemic disease affecting joint function (diabetes, rheumatological disorders, etc)","Previous lower extremity joint replacement","Lower quarter surgery, injection, or therapy in the past year","Other functionally-limiting physical impairment of the lower quarter","Spine or lower extremity compensation claim (work, accident, etc)","Inclusion Criteria:\n\n* Meets National Institute for Health and care Excellence (NICE) criteria for knee osteoarthritis:\n* Age 45 years or older\n* Movement-related knee pain\n* No morning stiffness or morning stiffness \\\u003C 30 minutes\n* Knee flexion contracture (kFC) at least 1cm, measured by heel-height\n* Fluency in verbal and written English for completion of outcome measure and screening, and to take directions.\n* Able to attend all study-related appointments\n\nExclusion Criteria:\n\n* Assistive device required for ambulation\n* Systemic disease affecting joint function (diabetes, rheumatological disorders, etc)\n* Previous lower extremity joint replacement\n* Lower quarter surgery, injection, or therapy in the past year\n* Other functionally-limiting physical impairment of the lower quarter\n* Spine or lower extremity compensation claim (work, accident, etc)",[78,79],"ADULT","OLDER_ADULT",[81,96],{"facility":82,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":93},"Texas Health Resources Sports Medicine Allen","Allen","Texas","75013","United States",[88],{"name":89,"role":90,"phone":91,"email":92},"Guy L Terry, MPT, PhD(c)","CONTACT","972-939-6501","gterry@twu.edu",{"lat":94,"lon":95},33.10317,-96.67055,{"facility":97,"city":98,"state":84,"zip":99,"country":86,"contacts":100,"geoPoint":102},"Texas Health Resources Plano Presbyterian Outpatient Rehabilitation","Plano","75093",[101],{"name":89,"role":90,"phone":91,"email":92},{"lat":103,"lon":104},33.01984,-96.69889,[106],{"name":89,"role":90,"phone":91,"email":92},[108],{"name":89,"affiliation":12,"role":109},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":113,"biomarkers":115},[114],"Osteoarthritis of knee",[],{"nct_id":4,"found":117,"summary":118,"prompt_version":128},true,{"design":119,"status":120,"heading":121,"summary":122,"follow_up":123,"word_count":124,"commitments":125,"compensation":126,"drugs_mentioned":127},"This is an interventional study that will randomly assign participants to one of two treatment groups. It plans to enroll 24 participants.","completed","Self-applied vs. Clinician-applied Joint Mobilization for Knee Osteoarthritis","This study is looking at how well self-applied joint mobilization, combined with exercise, works for adults with knee osteoarthritis. Researchers want to see if you doing joint mobilization yourself helps improve daily activities, knee movement, and hip strength. This will be compared to having a physical therapist perform the joint mobilization. The study is currently unclear on its status and plans to enroll 24 participants. Success will be measured by changes in your knee pain, stiffness, and ability to do daily activities, as reported on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire.","You will have a follow-up visit 6 months after your physical therapy sessions end.",95,"You would attend 8-12 physical therapy clinic visits over 6-8 weeks, perform home exercises, and have a brief check-up 6 months later. Each clinic visit will last 45 minutes.","Not stated in the trial record.",[],"v2"]