Conservative Treatment of Trigger Finger

Conservative Treatment of Trigger Finger: Outcomes of a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Hand Injuries; Trigger Finger
• Intervention / Treatment: Device: Oval-8 ® Orthosis; Other: Cortisone injection only

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 Type: Interventional
• Enrollment (Estimated): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Theodore Brown, BS; Phone Number: 800-700-6424; Email: Theodore.Brown@cshs.org
• Study Contact Backup: Name: Meghan McCullough, MD; Email: Meghan.McCullough@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Theodore Brown; Phone Number: 310-423-9200; Email: theodore.brown@cshs.org
    • Los Angeles, California, United States, 90048
      • Completed
      • Cedars-Sinai Medical Center Outpatient Rehabilitation Hand Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group with Cortisone Injection of affected digit(s) and nighttime 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.	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 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.; Other Names: Cortisone Injection
Active Comparator: Control Group-No Orthosis; 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.	Other: Cortisone injection only; The control group will receive a cortisone injection and be instructed to move their fingers normally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain	Visual Analogue Scale for Pain (0 pain free to 10 severe pain)	6 weeks
Change in Pain	Visual Analogue Scale for Pain (0 pain free to 10 severe pain)	12 weeks
Change in Perception of Function	QuickDash scores (0% no functional limitations to 100% disabled)	12 weeks

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Meghan McCullough, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendinopathy; Tendon Entrapment; Hand Injuries; Trigger Finger Disorder; Anti-Inflammatory Agents; Cortisone
• Other Study ID Numbers: 00002410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be available for sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No