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NCT Number: NCT05837286

Conservative Treatment of Trigger Finger

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.

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Key information

Conditions

Hand Injuries Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Entrapment Trigger Finger Trigger Finger Disorder Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oval-8 ® Orthosis

Device

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

Cortisone injection only

Other

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

Primary outcomes

  1. Resolution of Trigger Finger Symptoms

    Time frame: 6 Weeks

    Questionnaire used to determine resolution of Trigger Finger Symptoms

  2. Resolution of Trigger Finger Symptoms

    Time frame: 12 Weeks

    Questionnaire used to determine resolution of Trigger Finger Symptoms

Secondary outcomes

  1. Change in Pain

    Time frame: 6 weeks

    Visual Analogue Scale for Pain (0 pain free to 10 severe pain)

  2. Change in Pain

    Time frame: 12 weeks

    Visual Analogue Scale for Pain (0 pain free to 10 severe pain)

  3. Change in Perception of Function

    Time frame: 12 weeks

    QuickDash scores (0% no functional limitations to 100% disabled)

Study contacts

Contact information is provided by the study sponsor or research team.

Meghan McCullough, MD

CONTACT

[email protected]

Theodore Brown, BS

CONTACT

[email protected]

800-700-6424

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 1, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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