Conservative Treatment of Trigger Finger
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Cedars-Sinai Medical Center
- Study ID
- NCT05837286
- Status
- Recruiting
Conditions
- Hand Injuries
- Trigger Finger
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Oval-8 ® Orthosis — DEVICEThe 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.
- Cortisone injection only — OTHERThe control group will receive a cortisone injection and be instructed to move their fingers normally
Study Details
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.
Key Dates
- Start date
- Aug 1, 2023
- Status verified
- Mar 2026
- Primary completion
- May 31, 2026
- Completion
- May 31, 2026
Study Design
- Enrollment
- 146 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Experimental Group with Cortisone Injection of affected digit(s) and nighttime orthosisThe 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.
- Active Comparator: Control Group-No OrthosisThe 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.
Primary Outcome Measure
Resolution of Trigger Finger Symptoms [ Time Frame: 6 Weeks ]
Central Contacts
- Theodore Brown, BS800-700-6424
- Meghan McCullough, MD
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | |
| Cedars-Sinai Medical Center Outpatient Rehabilitation Hand Clinic | Los Angeles | California | 90048 | - |
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