Conservative Treatment of Trigger Finger

NCT ID: NCT05837286

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Hand Injuries Trigger Finger

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking

Study Groups

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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.

Group Type EXPERIMENTAL

Oval-8 ® Orthosis

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Cortisone injection only

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DEVICE

Cortisone injection only

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

Intervention Type OTHER

Other Intervention Names

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Cortisone Injection

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Pamela Roberts

Executive Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cedars-Sinai Medical Center Outpatient Rehabilitation Hand Clinic

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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April S O'Connell, BS

Role: CONTACT

310-423-9200

Pam Roberts, PhD

Role: CONTACT

8185900004

Facility Contacts

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Pamela Roberts, PhD

Role: primary

Other Identifiers

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00002410

Identifier Type: -

Identifier Source: org_study_id

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