Conservative Treatment of Trigger Finger
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oval-8 ® Orthosis, Cortisone injection only.
- Who it may be relevant to
- Registry conditions: Hand Injuries, Trigger Finger. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Conservative Treatment of Trigger Finger: Outcomes of a Randomized Controlled Trial
Overview
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
- 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 - Other Cortisone injection only
The control group will receive a cortisone injection and be instructed to move their fingers normally
Primary outcome measures
- Resolution of Trigger Finger Symptoms [Time frame: 6 Weeks]
- Resolution of Trigger Finger Symptoms [Time frame: 12 Weeks]
Secondary outcome measures (3)
- Change in Pain [Time frame: 6 weeks]
- Change in Pain [Time frame: 12 weeks]
- Change in Perception of Function [Time frame: 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Cedars-Sinai Medical Center Outpatient Rehabilitation Hand Clinic — Los Angeles
- Cedars-Sinai Medical Center — Los Angeles
Identifiers
NCT: NCT05837286 · 00002410