Trial record 2 of 2 for:    "Trigger thumb"

Study Comparing One Versus Two Cortisone Injections for Trigger Finger

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Rothman Institute Orthopaedics
Sponsor:
Information provided by:
Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT00951236
First received: July 31, 2009
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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 Intervention
Stenosing Tenosynovitis
Trigger Finger
Drug: One cortisone injection
Drug: Two cortisone Injections

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Study Comparing One vs. Two Cortisone Injections for Trigger Finger

Resource links provided by NLM:


Further study details as provided by Rothman Institute Orthopaedics:

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate treatment response among diabetic patients [ Designated as safety issue: No ]
  • To evaluate treatment response between thumbs and fingers [ Designated as safety issue: No ]
  • To evaluate treatment response between nodular versus diffuse tenosynovitis [ Designated as safety issue: No ]

Estimated Enrollment: 392
Study Start Date: May 2009
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951236

Contacts
Contact: Charles Leinberry, MD 267-339-3677 charlie.leinberry@rothmaninstitute.com
Contact: Tiffany Morrison, MS 267-339-7818 tiffany.morrison@rothmaninstitute.com

Locations
United States, New Jersey
Rothman Institute: Egg Harbor Township Location Recruiting
Egg Harbor Township, New Jersey, United States, 08234
Sub-Investigator: Emran Sheikh, MD         
Rothman Institute: Manahawkin location Recruiting
Manahawkin, New Jersey, United States, 08050
Sub-Investigator: Emran Sheikh, MD         
Rothman Institute: Vorhees location Recruiting
Vorhees, New Jersey, United States, 08043
Sub-Investigator: Pedro Berendjiklian, MD         
United States, Pennsylvania
Rothman Institute: Media location Recruiting
Media, Pennsylvania, United States, 19063
Sub-Investigator: Pedro Berendjiklian, MD         
Rothman Institute, South Philadelphia Location Recruiting
Philadelphia, Pennsylvania, United States, 19145
Principal Investigator: Charles Leinberry, MD         
Rothman Institute, Northeast Philadelphia location Recruiting
Philadelphia, Pennsylvania, United States, 19152
Principal Investigator: Charles Leinberry, MD         
Rothman Institute Center City Location Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Charles Leinberry, MD         
Sub-Investigator: Pedro Beredjiklian, MD         
Sub-Investigator: Emran Sheikh, MD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Charles Leinberry, MD, Rothman Institute
ClinicalTrials.gov Identifier: NCT00951236     History of Changes
Other Study ID Numbers: RIUCLEI 09-01
Study First Received: July 31, 2009
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rothman Institute Orthopaedics:
Trigger Finger
Trigger Thumb

Additional relevant MeSH terms:
Tenosynovitis
Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Cortisone acetate
Cortisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014