NCT00951236

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
392

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
Last Updated

February 12, 2014

Status Verified

February 1, 2014

First QC Date

July 31, 2009

Last Update Submit

February 10, 2014

Conditions

Keywords

Trigger FingerTrigger Thumb

Outcome Measures

Primary Outcomes (1)

  • To determine if there is a difference in the incidence of pain, stiffness, clicking or locking at 6 months following final injection

Secondary Outcomes (3)

  • To evaluate treatment response among diabetic patients

  • To evaluate treatment response between thumbs and fingers

  • To evaluate treatment response between nodular versus diffuse tenosynovitis

Study Arms (2)

One injection

ACTIVE COMPARATOR
Drug: One cortisone injection

Two Injections

ACTIVE COMPARATOR
Drug: Two cortisone Injections

Interventions

Patients in this arm will receive one cortisone injection for the treatment of his/her symptoms

One injection

Subjects randomized to this treatment will receive two cortisone injections, 4-6 weeks apart

Two Injections

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is greater than 18 years of age, presenting with stenosing tenosynovitis.
  • Subject is willing and able to provide informed consent.

You may not qualify if:

  • Patients who have previously undergone surgery for the treatment of trigger finger.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Rothman Institute: Egg Harbor Township Location

Egg Harbor, New Jersey, 08234, United States

RECRUITING

Rothman Institute: Manahawkin location

Manahawkin, New Jersey, 08050, United States

RECRUITING

Rothman Institute: Vorhees location

Vorhees, New Jersey, 08043, United States

RECRUITING

Rothman Institute: Media location

Media, Pennsylvania, 19063, United States

RECRUITING

Rothman Institute Center City Location

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Rothman Institute, South Philadelphia Location

Philadelphia, Pennsylvania, 19145, United States

RECRUITING

Rothman Institute, Northeast Philadelphia location

Philadelphia, Pennsylvania, 19152, United States

RECRUITING

MeSH Terms

Conditions

Tendon EntrapmentTrigger Finger Disorder

Condition Hierarchy (Ancestors)

TendinopathyMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Charles Leinberry, MD

    Rothman Institute

    PRINCIPAL INVESTIGATOR
  • Pedro Beredjiklian, MD

    Rothman Institute

    PRINCIPAL INVESTIGATOR
  • Emran Sheikh, MD

    Rothman Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 31, 2009

First Posted

August 4, 2009

Study Start

May 1, 2009

Last Updated

February 12, 2014

Record last verified: 2014-02

Locations