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 Locations

  • United States
    • 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
Drug: One cortisone injection
Patients in this arm will receive one cortisone injection for the treatment of his/her symptoms
Active Comparator: Two Injections
Drug: Two cortisone 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

Rothman Institute Orthopaedics

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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