Study Comparing One Versus Two Cortisone Injections for Trigger Finger
This study is currently recruiting participants.
Verified April 2013 by Rothman Institute Orthopaedics
Sponsor:
Rothman Institute Orthopaedics
Information provided by:
Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT00951236
First received: July 31, 2009
Last updated: April 8, 2013
Last verified: April 2013
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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
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: | April 8, 2013 |
| 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 May 22, 2013