[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07003113":3,"trial-entities:NCT07003113":115,"trial-summary:NCT07003113":120},{"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":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":63,"sex":68,"minimum_age":69,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":70,"std_ages":88,"locations":91,"central_contacts":107,"overall_officials":109,"references":113,"see_also_links":114},"NCT07003113","2024-0021","Ischemic Preconditioning in Osteoarthritis and Back Pain","RECRUITING","2026-12-31","2025-06","2025-11-17","2025-09-12","University of Illinois at Chicago","OTHER",false,"We are examining the use of restricted blood flow, through full occlusion, on a single thigh for 50 minutes (5 minutes on, 5 minutes off), completed every other day for 2 weeks to improve function in individuals with knee osteoarthritis and low back pain.",null,[18,19],"Low Back Pain","Knee Osteoarthritis",[21,22,23,24],"ischemic preconditioning","restricted blood flow","knee pain","back pain","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},24,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DEVICE","Ischemic Preconditioning","The intervention arm will include full blood flow occlusion in one thigh for 5 minutes followed by 5 minutes of reperfusion for a cycle of 50 minutes.",[38],"IC Arm",{"type":34,"name":40,"description":41,"armGroupLabels":42},"Sham Intervention","This intervention includes 25mmHg of pressure, which is not sufficient for blodo flow occlusion.",[43],"Sham Arm",[45,49,53,57,60],{"measure":46,"description":47,"timeFrame":48},"Preferred walking speed","Changes in preferred walking speed (m\u002Fs) from intervention","At baseline (from enrollment) until end of intervention (3 weeks).",{"measure":50,"description":51,"timeFrame":52},"Muscle strength","Change in quadriceps, hamstring, and hip strength","From baseline (enrollment) until end of intervention (3 weeks)",{"measure":54,"description":55,"timeFrame":56},"Patient Reported Outcomes","Change in subjective function and reporting based on questionnaires","At baseline (enrollment) through the intervention (3 weeks)",{"measure":58,"description":59,"timeFrame":48},"Gait Kinematics","Changes in gait kinematics (in degrees) from intervention",{"measure":61,"description":62,"timeFrame":48},"Gait Kinetics\u002FMoments","Changes in gait kinetics (joint moments) (in N\u002Fm) from intervention",[64],{"measure":65,"description":66,"timeFrame":67},"Cartilage Health","Change in knee cartilage thickness using ultrasound methods","From baseline (enrollment) until completion of intervention (3 weeks)","ALL","50 Years",{"inclusion":71,"exclusion":76,"raw_text":87},[72,73,74,75],"Reported Knee Pain using ACR Criteria","Reported Back Pain using ODI Criteria \\> 12","Ability to walk for at least 3 minutes without the use of aids","Ability to provide written informed consent",[77,78,79,80,81,82,83,84,85,86],"Younger than 50 years old","History of Knee or Hip Replacements","History of steroid injection within the previous 6 months","Presence of neuromuscular joint condition that affects lower extremity function","History of blood clots in the leg or any condition in which compression of the thigh is contraindicated","History of heart failure or thrombosis","Allergic to ultrasound gel","History of spine surgery","Non-English speaker","Currently pregnant or intends to become pregnant during the study","Inclusion Criteria:\n\n* Reported Knee Pain using ACR Criteria\n* Reported Back Pain using ODI Criteria \\> 12\n* Ability to walk for at least 3 minutes without the use of aids\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Younger than 50 years old\n* History of Knee or Hip Replacements\n* History of steroid injection within the previous 6 months\n* Presence of neuromuscular joint condition that affects lower extremity function\n* History of blood clots in the leg or any condition in which compression of the thigh is contraindicated\n* History of heart failure or thrombosis\n* Allergic to ultrasound gel\n* History of spine surgery\n* Non-English speaker\n* Currently pregnant or intends to become pregnant during the study",[89,90],"ADULT","OLDER_ADULT",[92],{"facility":93,"status":7,"city":94,"state":95,"zip":96,"country":97,"contacts":98,"geoPoint":104},"Human and Sport Performance Lab","Chicago","Illinois","60608","United States",[99],{"name":100,"role":101,"phone":102,"email":103},"Shraddha Sudhir","CONTACT","312-413-5118","ssudhi5@uic.edu",{"lat":105,"lon":106},41.85003,-87.65005,[108],{"name":100,"role":101,"phone":102,"email":103},[110],{"name":111,"affiliation":12,"role":112},"Lindsay Hannigan","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":116,"biomarkers":119},[117,118],"Lower Back Pain","Osteoarthritis of knee",[],{"nct_id":4,"found":121,"summary":122,"prompt_version":132},true,{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 24 participants.","completed","Ischemic Preconditioning for Osteoarthritis and Back Pain","This study is looking at a treatment called Ischemic Preconditioning for people with knee osteoarthritis and low back pain. This treatment involves temporarily restricting blood flow to one thigh for 50 minutes, in cycles of 5 minutes on and 5 minutes off, every other day for two weeks. Researchers want to see if this helps improve your walking speed, muscle strength, and how you feel about your pain and function (Patient Reported Outcomes). You might be able to join if you are 50 years or older, have knee pain and back pain, and can walk for at least 3 minutes without help. The study is currently unclear about its recruitment status and plans to enroll 24 participants.","Your progress will be tracked from the start of the study until the end of the 3-week intervention period.",117,"You would receive the Ischemic Preconditioning or a sham intervention every other day for two weeks. Your walking speed, muscle strength, and patient-reported outcomes will be measured at the beginning and end of the intervention.","Not stated in the trial record.",[35],"v2"]