Recruiting

Conservative Treatment

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT05837286

Conditions

Hand Injuries

Trigger Finger

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Oval-8 ® Orthosis

Cortisone injection only

Study Details

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.

Conditions

Hand Injuries

Trigger Finger

Study ID

NCT05837286

Start date

Aug 1, 2023

Status verified date

Mar, 2026

Completion date

May 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

146 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Cortisone injection only

The control group will receive a cortisone injection and be instructed to move their fingers normally

Primary outcome measure

  • Resolution of Trigger Finger Symptoms [ Time Frame: 6 Weeks ]
  • Resolution of Trigger Finger Symptoms [ Time Frame: 12 Weeks ]

Central Contacts and Locations

Central contacts

Theodore Brown, BS

800-700-6424Theodore.Brown@cshs.org

Meghan McCullough, MD

Meghan.McCullough@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Theodore Brown

310-423-9200theodore.brown@cshs.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-03-27.