Hand Injuries, Trigger Finger
Conditions
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.
Detailed description
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.
Interventions
DEVICEOval-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.
OTHERCortisone injection only
The control group will receive a cortisone injection and be instructed to move their fingers normally
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking
Intervention model description
The primary objective of this study is to analyze the effectiveness of a nighttime PIP joint extension orthosis to improve pain and restore functional outcomes in TF and comparing two groups of participants with TF, one group receiving a cortisone injection only and the experimental group receiving the nighttime orthosis after cortisone injection using the QuickDASH.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of Trigger Finger Symptoms | 6 Weeks | Questionnaire used to determine resolution of Trigger Finger Symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain | 6 weeks | Visual Analogue Scale for Pain (0 pain free to 10 severe pain) |
| Change in Perception of Function | 12 weeks | QuickDash scores (0% no functional limitations to 100% disabled) |
Countries
United States
Contacts
CONTACTTheodore Brown, BS
CONTACTMeghan McCullough, MD
PRINCIPAL_INVESTIGATORMeghan McCullough, MD
Cedars-Sinai Medical Center
Outcome results
None listed