Conservative Treatment of Trigger Finger

Cedars-Sinai Medical Center

Status: Enrolling

Conditions: Hand Injuries; Trigger Finger

Treatments: Other: Cortisone injection only; Device: Oval-8 ® Orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT05837286

00002410

Details and patient eligibility

About

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.

Full 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.

Enrollment: 146 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Experimental Group with Cortisone Injection of affected digit(s) and nighttime orthosis

Experimental group

Description:

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.

Treatment:

Device: Oval-8 ® Orthosis

Control Group-No Orthosis

Active Comparator group

Description:

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.

Treatment:

Other: Cortisone injection only