- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00951236
Study Comparing One Versus Two Cortisone Injections for Trigger Finger
February 10, 2014 updated by: Rothman Institute Orthopaedics
A Prospective, Randomized Study Comparing One vs. Two Cortisone Injections for Trigger Finger
Trigger finger, also known as stenosing tenosynovitis, is a painful condition that can cause discomfort and disability.
Many physicians choose to locally inject cortisone into the infected finger although there is no current consensus as to how many injections are needed to achieve maximum relief.
This study will be a prospective, randomized study to compare one versus two injections for the treatment of trigger finger.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
392
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tiffany Morrison, MS
- Phone Number: 267-339-7818
- Email: tiffany.morrison@rothmaninstitute.com
Study Contact Backup
- Name: Charles Leinberry, MD
- Phone Number: 267-339-3677
- Email: charlie.leinberry@rothmaninstitute.com
Study Locations
-
-
New Jersey
-
Egg Harbor Township, New Jersey, United States, 08234
- Recruiting
- Rothman Institute: Egg Harbor Township Location
-
Sub-Investigator:
- Emran Sheikh, MD
-
Manahawkin, New Jersey, United States, 08050
- Recruiting
- Rothman Institute: Manahawkin location
-
Sub-Investigator:
- Emran Sheikh, MD
-
Vorhees, New Jersey, United States, 08043
- Recruiting
- Rothman Institute: Vorhees location
-
Sub-Investigator:
- Pedro Berendjiklian, MD
-
-
Pennsylvania
-
Media, Pennsylvania, United States, 19063
- Recruiting
- Rothman Institute: Media location
-
Sub-Investigator:
- Pedro Berendjiklian, MD
-
Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Rothman Institute Center City Location
-
Sub-Investigator:
- Emran Sheikh, MD
-
Principal Investigator:
- Charles Leinberry, MD
-
Sub-Investigator:
- Pedro Beredjiklian, MD
-
Philadelphia, Pennsylvania, United States, 19145
- Recruiting
- Rothman Institute, South Philadelphia Location
-
Principal Investigator:
- Charles Leinberry, MD
-
Philadelphia, Pennsylvania, United States, 19152
- Recruiting
- Rothman Institute, Northeast Philadelphia location
-
Principal Investigator:
- Charles Leinberry, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is greater than 18 years of age, presenting with stenosing tenosynovitis.
- Subject is willing and able to provide informed consent.
Exclusion Criteria:
- Patients who have previously undergone surgery for the treatment of trigger finger.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: One injection
|
Patients in this arm will receive one cortisone injection for the treatment of his/her symptoms
|
Active Comparator: Two Injections
|
Subjects randomized to this treatment will receive two cortisone injections, 4-6 weeks apart
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
To determine if there is a difference in the incidence of pain, stiffness, clicking or locking at 6 months following final injection
|
Secondary Outcome Measures
Outcome Measure |
---|
To evaluate treatment response among diabetic patients
|
To evaluate treatment response between thumbs and fingers
|
To evaluate treatment response between nodular versus diffuse tenosynovitis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Charles Leinberry, MD, Rothman Institute
- Principal Investigator: Pedro Beredjiklian, MD, Rothman Institute
- Principal Investigator: Emran Sheikh, MD, Rothman Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Study Registration Dates
First Submitted
July 31, 2009
First Submitted That Met QC Criteria
August 3, 2009
First Posted (Estimate)
August 4, 2009
Study Record Updates
Last Update Posted (Estimate)
February 12, 2014
Last Update Submitted That Met QC Criteria
February 10, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIUCLEI 09-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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