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Corticosteroid

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

N/A
Recruiting
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with trigger finger, aka stenosing flexor tenosynovitis
Status post receiving cortisone injection of the affected digit(s)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial aims to see if wearing a nighttime extension brace after getting a cortisone injection for trigger finger can help reduce pain and improve hand function. Researchers believe that using the brace will lead to better

Who is the study for?
This trial is for adults over 18 with trigger finger who have had a cortisone injection in the affected fingers. It's not suitable for those who haven't received this injection or may have other hand injuries.Check my eligibility
What is being tested?
The study tests if wearing an Oval-8® Orthosis at night after a cortisone shot helps reduce pain and improve finger function compared to not using the orthosis following the treatment.See study design
What are the potential side effects?
Possible side effects include discomfort from wearing the orthosis, skin irritation, or increased stiffness in the morning. The cortisone injection might cause temporary pain increase, infection risk, or tendon weakening.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have trigger finger.
Select...
I have received a cortisone injection in my finger(s).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Resolution of Trigger Finger Symptoms
Secondary outcome measures
Change in Pain
Change in Perception of Function

Side effects data

From 2018 Phase 4 trial • 1670 Patients • NCT02261727
32%
COPD Exacerbation - not hospitalised
16%
COPD Exacerbation - Hospitalised
7%
Upper Respiratory Tract Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Low-dose Theophylline Arm
Theophylline and Prednisone Arm

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Group with Cortisone Injection of affected digit(s) and nighttime orthosisExperimental Treatment1 Intervention
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 II: Control Group-No OrthosisActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
500 Previous Clinical Trials
164,717 Total Patients Enrolled
1 Trials studying Hand Injuries
45 Patients Enrolled for Hand Injuries

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current size of the patient cohort being observed in this clinical investigation?

"Affirmative. The details provided on clinicaltrials.gov clearly indicate that this investigation is actively seeking eligible participants. Initially shared on August 1st, 2023, and most recently revised on February 5th, 2024, the study aims to recruit a total of 146 individuals from a single designated site."

Answered by AI

Is the enrollment process currently open for this research study?

"As per the details available on clinicaltrials.gov, this medical investigation is currently seeking suitable participants. The trial was first made public on August 1st, 2023 and underwent its most recent revision on February 5th, 2024."

Answered by AI

Is the clinical trial open to individuals who are below 45 years of age?

"Eligible candidates for this research endeavor must be between 18 and 100 years old. Notably, there are separate trials available for individuals under 18 and those over 65."

Answered by AI

Who else is applying?

What site did they apply to?
Cedars-Sinai Medical Center Outpatient Rehabilitation Hand Clinic
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Conservative Treatment of Trigger Finger
Pamela Roberts 2023. "Conservative Treatment of Trigger Finger". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05837286.
~56 spots leftby Sep 2024
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