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Conservative Treatment of Trigger Finger

Primary Purpose

Hand Injuries, Trigger Finger

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oval-8 ® Orthosis
Cortisone injection only
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand Injuries

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

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

    Control Group-No Orthosis

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Resolution of Trigger Finger Symptoms
    Questionnaire used to determine resolution of Trigger Finger Symptoms
    Resolution of Trigger Finger Symptoms
    Questionnaire used to determine resolution of Trigger Finger Symptoms

    Secondary Outcome Measures

    Change in Pain
    Visual Analogue Scale for Pain (0 pain free to 10 severe pain)
    Change in Pain
    Visual Analogue Scale for Pain (0 pain free to 10 severe pain)
    Change in Perception of Function
    QuickDash scores (0% no functional limitations to 100% disabled)

    Full Information

    First Posted
    April 5, 2023
    Last Updated
    April 27, 2023
    Sponsor
    Cedars-Sinai Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05837286
    Brief Title
    Conservative Treatment of Trigger Finger
    Official Title
    Conservative Treatment of Trigger Finger: Outcomes of a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    May 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cedars-Sinai Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hand Injuries, Trigger Finger

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The primary objective of this study is to analyze the effectiveness of a nighttime PIP joint extension orthosis to improve pain and restore functional outcomes in TF and comparing two groups of participants with TF, one group receiving a cortisone injection only and the experimental group receiving the nighttime orthosis after cortisone injection using the QuickDASH.
    Masking
    None (Open Label)
    Masking Description
    No masking
    Allocation
    Randomized
    Enrollment
    146 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group with Cortisone Injection of affected digit(s) and nighttime orthosis
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Control Group-No Orthosis
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    Oval-8 ® Orthosis
    Other Intervention Name(s)
    Cortisone Injection
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    Cortisone injection only
    Intervention Description
    The control group will receive a cortisone injection and be instructed to move their fingers normally
    Primary Outcome Measure Information:
    Title
    Resolution of Trigger Finger Symptoms
    Description
    Questionnaire used to determine resolution of Trigger Finger Symptoms
    Time Frame
    6 Weeks
    Title
    Resolution of Trigger Finger Symptoms
    Description
    Questionnaire used to determine resolution of Trigger Finger Symptoms
    Time Frame
    12 Weeks
    Secondary Outcome Measure Information:
    Title
    Change in Pain
    Description
    Visual Analogue Scale for Pain (0 pain free to 10 severe pain)
    Time Frame
    6 weeks
    Title
    Change in Pain
    Description
    Visual Analogue Scale for Pain (0 pain free to 10 severe pain)
    Time Frame
    12 weeks
    Title
    Change in Perception of Function
    Description
    QuickDash scores (0% no functional limitations to 100% disabled)
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pamela S Roberts, PhD
    Phone
    310-423-6660
    Email
    pamela.roberts@cshs.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    April O'Connell, BS
    Phone
    310-423-9200
    Email
    april.oconnell@cshs.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Individual participant data will not be available for sharing.

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    Conservative Treatment of Trigger Finger

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