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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.

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Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
503 Previous Clinical Trials
165,727 Total Patients Enrolled
1 Trials studying Hand Injuries
45 Patients Enrolled for Hand Injuries
~34 spots leftby Sep 2024
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