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Conservative Treatment of Trigger Finger

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ClinicalTrials.gov Identifier: NCT05837286
Recruitment Status : Recruiting
First Posted : May 1, 2023
Last Update Posted : February 7, 2024
Sponsor:
Information provided by (Responsible Party):
Pamela Roberts, Cedars-Sinai Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hand Injuries Trigger Finger Device: Oval-8 ® Orthosis Other: Cortisone injection only Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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
Primary Purpose: Treatment
Official Title: Conservative Treatment of Trigger Finger: Outcomes of a Randomized Controlled Trial
Actual Study Start Date : August 1, 2023
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : December 31, 2024

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Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05837286


Contacts
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Contact: April S O'Connell, BS 310-423-9200 April.oconnell@cshs.org
Contact: Pam Roberts, PhD 8185900004 pamela.roberts@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center Outpatient Rehabilitation Hand Clinic Recruiting
Los Angeles, California, United States, 90048
Contact: Pamela Roberts, PhD         
Principal Investigator: Pamela Roberts, PhD         
Sub-Investigator: April OConnell, BS         
Sponsors and Collaborators
Cedars-Sinai Medical Center
More Information
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Responsible Party: Pamela Roberts, Executive Director, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT05837286    
Other Study ID Numbers: 00002410
First Posted: May 1, 2023    Key Record Dates
Last Update Posted: February 7, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be available for sharing.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Trigger Finger Disorder
Hand Injuries
Tendon Entrapment
Tendinopathy
Muscular Diseases
 Musculoskeletal Diseases
Wounds and Injuries
Cortisone
Anti-Inflammatory Agents