Conservative Treatment of Trigger Finger
1 other identifier
interventional
146
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2023
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
CompletedMarch 27, 2026
March 1, 2026
2.8 years
April 5, 2023
March 24, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Resolution of Trigger Finger Symptoms
Questionnaire used to determine resolution of Trigger Finger Symptoms
6 Weeks
Resolution of Trigger Finger Symptoms
Questionnaire used to determine resolution of Trigger Finger Symptoms
12 Weeks
Secondary Outcomes (3)
Change in Pain
6 weeks
Change in Pain
12 weeks
Change in Perception of Function
12 weeks
Study Arms (2)
Experimental Group with Cortisone Injection of affected digit(s) and nighttime orthosis
EXPERIMENTALThe 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.
Control Group-No Orthosis
ACTIVE COMPARATORThe 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.
Interventions
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.
The control group will receive a cortisone injection and be instructed to move their fingers normally
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cedars-Sinai Medical Center Outpatient Rehabilitation Hand Clinic
Los Angeles, California, 90048, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meghan McCullough, MD
Cedars-Sinai Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- No masking
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
April 5, 2023
First Posted
May 1, 2023
Study Start
August 1, 2023
Primary Completion
May 31, 2026
Study Completion
May 31, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be available for sharing.