Study Comparing One Versus Two Cortisone Injections for Trigger Finger

Sponsor

Rothman Institute Orthopaedics (Other)

Overall Status

Unknown status

CT.gov ID

NCT00951236

Collaborator

(none)

392

Enrollment

Locations

Arms

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stenosing Tenosynovitis Trigger Finger	Drug: One cortisone injection Drug: Two cortisone Injections	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

392 participants

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Official Title:

A Prospective, Randomized Study Comparing One vs. Two Cortisone Injections for Trigger Finger

Study Start Date :

May 1, 2009

Arms and Interventions

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

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

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Institute: Egg Harbor Township Location	Egg Harbor Township	New Jersey	United States	08234
2	Rothman Institute: Manahawkin location	Manahawkin	New Jersey	United States	08050
3	Rothman Institute: Vorhees location	Vorhees	New Jersey	United States	08043
4	Rothman Institute: Media location	Media	Pennsylvania	United States	19063
5	Rothman Institute Center City Location	Philadelphia	Pennsylvania	United States	19107
6	Rothman Institute, South Philadelphia Location	Philadelphia	Pennsylvania	United States	19145
7	Rothman Institute, Northeast Philadelphia location	Philadelphia	Pennsylvania	United States	19152