[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05837286":3,"trial-entities:NCT05837286":110,"trial-summary:NCT05837286":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":43,"secondary_outcomes":50,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":15,"eligibility_criteria":63,"std_ages":75,"locations":78,"central_contacts":97,"overall_officials":105,"references":108,"see_also_links":109},"NCT05837286","00002410","Conservative Treatment of Trigger Finger","Conservative Treatment of Trigger Finger: Outcomes of a Randomized Controlled Trial","RECRUITING","2026-05-31","2026-03","2026-03-27","2023-08-01","Cedars-Sinai Medical Center","OTHER",false,"This study is to analyze the effectiveness of a nighttime extension orthosis after receiving a cortisone injection for the treatment of trigger finger to improve pain and restore functional outcomes. The investigators hypothesize that the extension orthosis will improve pain and functional outcomes compared to those without a digital night extension orthosis in those with trigger finger at 12 weeks from the injection.","The purpose of the research is to analyze the effectiveness of a proximal interphalangeal joint (PIPJ) extension night orthosis status-post cortisone injection of the first annular pulley for the treatment of trigger finger to improve pain and restore functional outcomes. The investigators hypothesize that the extension orthosis will improve pain and functional outcomes (Quick Dash score) compared to those without a digital night extension orthosis in those with trigger finger at 12 weeks from the injection.",[19,20],"Hand Injuries","Trigger Finger",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},146,"ESTIMATED",[30,38],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DEVICE","Oval-8 ® Orthosis","The experimental group will consist of receiving a PIP joint on the day they receive their cortisone injection. The Oval-8 ® will be issued to the subject by an Occupational Therapist to ensure correct fit and comfort as well as given written instructions for night use. The orthosis will be worn at night for 6-week duration. Participants will have 1 follow up phone call or email at the 6-week mark and then 1 follow up phone call or email at the 12 week mark by a member of the research team from the time they received their cortisone injection where the time for resolution of trigger finger symptoms, VAS (Visual Analogue Scale), subjective questionnaire and QuickDASH scores will all be recorded in their medical research file.",[35],"Experimental Group with Cortisone Injection of affected digit(s) and nighttime orthosis",[37],"Cortisone Injection",{"type":14,"name":39,"description":40,"armGroupLabels":41},"Cortisone injection only","The control group will receive a cortisone injection and be instructed to move their fingers normally",[42],"Control Group-No Orthosis",[44,48],{"measure":45,"description":46,"timeFrame":47},"Resolution of Trigger Finger Symptoms","Questionnaire used to determine resolution of Trigger Finger Symptoms","6 Weeks",{"measure":45,"description":46,"timeFrame":49},"12 Weeks",[51,55,57],{"measure":52,"description":53,"timeFrame":54},"Change in Pain","Visual Analogue Scale for Pain (0 pain free to 10 severe pain)","6 weeks",{"measure":52,"description":53,"timeFrame":56},"12 weeks",{"measure":58,"description":59,"timeFrame":56},"Change in Perception of Function","QuickDash scores (0% no functional limitations to 100% disabled)","ALL","18 Years","100 Years",{"inclusion":64,"exclusion":68,"raw_text":74},[65,66,67],"Individuals 18 years old or older are included","Patients with trigger finger, aka stenosing flexor tenosynovitis","Status post receiving cortisone injection of the affected digit(s)",[69,70,71,72,73],"Any records flagged with break the glass or research opt out","Patients with rheumatoid arthritis","Patients with a history of traumatic injury to the hand","Cognitive or behavioral problems which would preclude informed consent","Unable to speak and understand English","Inclusion Criteria:\n\n* Individuals 18 years old or older are included\n* Patients with trigger finger, aka stenosing flexor tenosynovitis\n* Status post receiving cortisone injection of the affected digit(s)\n\nExclusion Criteria:\n\n* Any records flagged with break the glass or research opt out\n* Patients with rheumatoid arthritis\n* Patients with a history of traumatic injury to the hand\n* Cognitive or behavioral problems which would preclude informed consent\n* Unable to speak and understand English",[76,77],"ADULT","OLDER_ADULT",[79,89],{"facility":80,"status":81,"city":82,"state":83,"zip":84,"country":85,"geoPoint":86},"Cedars-Sinai Medical Center Outpatient Rehabilitation Hand Clinic","COMPLETED","Los Angeles","California","90048","United States",{"lat":87,"lon":88},34.05223,-118.24368,{"facility":13,"status":8,"city":82,"state":83,"zip":84,"country":85,"contacts":90,"geoPoint":96},[91],{"name":92,"role":93,"phone":94,"email":95},"Theodore Brown","CONTACT","310-423-9200","theodore.brown@cshs.org",{"lat":87,"lon":88},[98,102],{"name":99,"role":93,"phone":100,"email":101},"Theodore Brown, BS","800-700-6424","Theodore.Brown@cshs.org",{"name":103,"role":93,"email":104},"Meghan McCullough, MD","Meghan.McCullough@cshs.org",[106],{"name":103,"affiliation":13,"role":107},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":111,"biomarkers":113},[112],"Acquired trigger finger",[],{"nct_id":4,"found":115,"summary":116,"prompt_version":126},true,{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is an interventional study comparing two groups: one receiving a cortisone injection and a night splint, and another receiving only a cortisone injection. It plans to enroll 146 participants.","completed","Trigger Finger Treatment Study: Cortisone Injection with or without a Night Splint","This study is looking at how well a night splint (Oval-8® Orthosis) works when used after a cortisone injection for trigger finger. Trigger finger (stenosing flexor tenosynovitis) is a condition where a finger gets stuck in a bent position. Some participants will receive a cortisone injection and wear the Oval-8® Orthosis at night, while others will only receive the cortisone injection and move their fingers normally. The researchers want to see if the night splint helps improve pain and finger function more than the injection alone. You might be able to join if you are 18 or older and have trigger finger. The study aims to enroll 146 people, but its current status is unclear.","Your trigger finger symptoms will be checked at 6 weeks and 12 weeks after the injection.",115,"Participants will receive a cortisone injection. If in the experimental group, you will also receive an Oval-8® Orthosis and instructions for night use.","Not stated in the trial record.",[],"v2"]