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Study Comparing One Versus Two Cortisone Injections for Trigger Finger

Primary Purpose

Stenosing Tenosynovitis, Trigger Finger

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
One cortisone injection
Two cortisone Injections
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stenosing Tenosynovitis focused on measuring Trigger Finger, Trigger Thumb

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rothman Institute: Egg Harbor Township LocationRecruiting
  • Rothman Institute: Manahawkin locationRecruiting
  • Rothman Institute: Vorhees locationRecruiting
  • Rothman Institute: Media locationRecruiting
  • Rothman Institute Center City LocationRecruiting
  • Rothman Institute, South Philadelphia LocationRecruiting
  • Rothman Institute, Northeast Philadelphia locationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

One injection

Two Injections

Arm Description

Outcomes

Primary Outcome Measures

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

To evaluate treatment response among diabetic patients
To evaluate treatment response between thumbs and fingers
To evaluate treatment response between nodular versus diffuse tenosynovitis

Full Information

First Posted
July 31, 2009
Last Updated
February 10, 2014
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT00951236
Brief Title
Study Comparing One Versus Two Cortisone Injections for Trigger Finger
Official Title
A Prospective, Randomized Study Comparing One vs. Two Cortisone Injections for Trigger Finger
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stenosing Tenosynovitis, Trigger Finger
Keywords
Trigger Finger, Trigger Thumb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Enrollment
392 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One injection
Arm Type
Active Comparator
Arm Title
Two Injections
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
One cortisone injection
Intervention Description
Patients in this arm will receive one cortisone injection for the treatment of his/her symptoms
Intervention Type
Drug
Intervention Name(s)
Two cortisone Injections
Intervention Description
Subjects randomized to this treatment will receive two cortisone injections, 4-6 weeks apart
Primary Outcome Measure Information:
Title
To determine if there is a difference in the incidence of pain, stiffness, clicking or locking at 6 months following final injection
Secondary Outcome Measure Information:
Title
To evaluate treatment response among diabetic patients
Title
To evaluate treatment response between thumbs and fingers
Title
To evaluate treatment response between nodular versus diffuse tenosynovitis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Leinberry, MD
Phone
267-339-3677
Email
charlie.leinberry@rothmaninstitute.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany Morrison, MS
Phone
267-339-7818
Email
tiffany.morrison@rothmaninstitute.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Leinberry, MD
Organizational Affiliation
Rothman Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pedro Beredjiklian, MD
Organizational Affiliation
Rothman Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emran Sheikh, MD
Organizational Affiliation
Rothman Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rothman Institute: Egg Harbor Township Location
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emran Sheikh, MD
Facility Name
Rothman Institute: Manahawkin location
City
Manahawkin
State/Province
New Jersey
ZIP/Postal Code
08050
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emran Sheikh, MD
Facility Name
Rothman Institute: Vorhees location
City
Vorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Berendjiklian, MD
Facility Name
Rothman Institute: Media location
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Berendjiklian, MD
Facility Name
Rothman Institute Center City Location
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Leinberry, MD
First Name & Middle Initial & Last Name & Degree
Pedro Beredjiklian, MD
First Name & Middle Initial & Last Name & Degree
Emran Sheikh, MD
Facility Name
Rothman Institute, South Philadelphia Location
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19145
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Leinberry, MD
Facility Name
Rothman Institute, Northeast Philadelphia location
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Leinberry, MD

12. IPD Sharing Statement

Learn more about this trial

Study Comparing One Versus Two Cortisone Injections for Trigger Finger

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