Conservative Treatment of Trigger Finger

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

Tracking Information

• First Submitted Date: April 5, 2023
• First Posted Date: May 1, 2023
• Last Update Posted Date: February 7, 2024
• Actual Study Start Date: August 1, 2023
• Estimated Primary Completion Date: September 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 27, 2023)

• Resolution of Trigger Finger Symptoms [ Time Frame: 6 Weeks ]
  Questionnaire used to determine resolution of Trigger Finger Symptoms
• Resolution of Trigger Finger Symptoms [ Time Frame: 12 Weeks ]
  Questionnaire used to determine resolution of Trigger Finger Symptoms

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 27, 2023)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Conservative Treatment of Trigger Finger
• Official Title: Conservative Treatment of Trigger Finger: Outcomes of a Randomized Controlled Trial
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Hand Injuries
• Trigger Finger

Intervention

• 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
• Other: Cortisone injection only
  The control group will receive a cortisone injection and be instructed to move their fingers normally

Study 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.
  Intervention: Device: Oval-8 ® Orthosis
• 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.
  Intervention: Other: Cortisone injection only

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 27, 2023): 146
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: September 30, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: April S O'Connell, BS; 310-423-9200; April.oconnell@cshs.org

Contact: Pam Roberts, PhD; 8185900004; pamela.roberts@cshs.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05837286
• Other Study ID Numbers: 00002410
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

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

• Current Responsible Party: Pamela Roberts, Cedars-Sinai Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Cedars-Sinai Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Cedars-Sinai Medical Center
• Verification Date: February 2024