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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00951236
Other study ID # RIUCLEI 09-01
Secondary ID
Status Recruiting
Phase N/A
First received July 31, 2009
Last updated February 10, 2014
Start date May 2009

Study information

Verified date February 2014
Source Rothman Institute Orthopaedics
Contact Charles Leinberry, MD
Phone 267-339-3677
Email charlie.leinberry@rothmaninstitute.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 392
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment


Intervention

Drug:
One cortisone injection
Patients in this arm will receive one cortisone injection for the treatment of his/her symptoms
Two cortisone Injections
Subjects randomized to this treatment will receive two cortisone injections, 4-6 weeks apart

Locations

Country Name City State
United States Rothman Institute: Egg Harbor Township Location Egg Harbor Township New Jersey
United States Rothman Institute: Manahawkin location Manahawkin New Jersey
United States Rothman Institute: Media location Media Pennsylvania
United States Rothman Institute Center City Location Philadelphia Pennsylvania
United States Rothman Institute, Northeast Philadelphia location Philadelphia Pennsylvania
United States Rothman Institute, South Philadelphia Location Philadelphia Pennsylvania
United States Rothman Institute: Vorhees location Vorhees New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine if there is a difference in the incidence of pain, stiffness, clicking or locking at 6 months following final injection No
Secondary To evaluate treatment response among diabetic patients No
Secondary To evaluate treatment response between thumbs and fingers No
Secondary To evaluate treatment response between nodular versus diffuse tenosynovitis No
See also
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Completed NCT01987115 - Comparison of Fascial Manipulation With Traditional Physiotherapy for the Treatment of Trigger Fingers N/A
Completed NCT02196233 - Surgical Treatment of Adult Trigger Finger
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Recruiting NCT04675892 - Resection of Flexor Digitorum Superficialis Tendon for Severe Trigger Fingers N/A
Terminated NCT05082480 - Evaluate the Effectiveness of Crosslinked HA on the Adhesion Preventing After Trigger Finger Release Surgery N/A
Recruiting NCT05045157 - Effectiveness of Percutaneous Pulley Release With Infiltration, Versus Infiltration Alone in Trigger Finders N/A
Active, not recruiting NCT01886157 - Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting N/A
Withdrawn NCT04855942 - Focused Extracorporeal Shock Wave Therapy (ESWT) Versus Traditional Physiotherapy in the Treatment of Trigger Finger N/A