An interventional study of Oval-8 ® Orthosis and Cortisone injection only in Hand Injuries and Trigger Finger, sponsored by Cedars-Sinai Medical Center. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Treatment
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.
122 studies on the registry are indexed under Hand Injuries; 35 are open to participants now.
This study's planned enrollment of 146 is above the median of 55 across 97 interventional studies indexed under Hand Injuries.
Browse Hand Injuries studies →Cedars-Sinai Medical Center is the lead sponsor of 456 studies on the registry; 107 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 49 (75%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Oval-8 ® Orthosis
The control group will be identical to the experimental group except without the use of a nighttime orthosis. 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.
Other: Cortisone injection only
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.
Also known as: Cortisone Injection
The control group will receive a cortisone injection and be instructed to move their fingers normally
Resolution of Trigger Finger Symptoms
Questionnaire used to determine resolution of Trigger Finger Symptoms
Time frame: 6 Weeks
Resolution of Trigger Finger Symptoms
Questionnaire used to determine resolution of Trigger Finger Symptoms
Time frame: 12 Weeks
Change in Pain
Visual Analogue Scale for Pain (0 pain free to 10 severe pain)
Time frame: 6 weeks
Change in Pain
Visual Analogue Scale for Pain (0 pain free to 10 severe pain)
Time frame: 12 weeks
Change in Perception of Function
QuickDash scores (0% no functional limitations to 100% disabled)
Time frame: 12 weeks
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Plan to share: No — Individual participant data will not be available for sharing.
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