Conservative Treatment of Trigger Finger

Not Applicable

Recruiting

• Conditions: Trigger Finger; Hand Injuries
• Interventions: Other: Cortisone injection only; Device: Oval-8 ® Orthosis

• Registration Number: NCT05837286
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Study Timeline

• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-04-27
• Study First Posted: 2023-05-01
• Study Start: 2023-08-01
• Status Verified: 2024-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group-No Orthosis	Cortisone injection only	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.
Experimental Group with Cortisone Injection of affected digit(s) and nighttime orthosis	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 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 Measures

Name	Time	Method
Resolution of Trigger Finger Symptoms	12 Weeks	Questionnaire used to determine resolution of Trigger Finger Symptoms

Secondary Outcome Measures

Name	Time	Method
Change in Pain	12 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)

Trial Locations

Locations (1)

Cedars-Sinai Medical Center Outpatient Rehabilitation Hand Clinic; 🇺🇸 Los Angeles, California, United States