Conservative Treatment of Trigger Finger

Hand Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05837286
• Other study ID #: 00002410
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Cedars-Sinai Medical Center
• Contact: April S O'Connell, BS
• Phone: 310-423-9200
• Email: April.oconnell[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Hand Injuries
• Trigger Finger
• Trigger Finger Disorder

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

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center Outpatient Rehabilitation Hand Clinic	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of Trigger Finger Symptoms	Questionnaire used to determine resolution of Trigger Finger Symptoms	6 Weeks
Primary	Resolution of Trigger Finger Symptoms	Questionnaire used to determine resolution of Trigger Finger Symptoms	12 Weeks
Secondary	Change in Pain	Visual Analogue Scale for Pain (0 pain free to 10 severe pain)	6 weeks
Secondary	Change in Pain	Visual Analogue Scale for Pain (0 pain free to 10 severe pain)	12 weeks
Secondary	Change in Perception of Function	QuickDash scores (0% no functional limitations to 100% disabled)	12 weeks