Stenosing TenosynovitisNCT00951236
Study Comparing One Versus Two Cortisone Injections for Trigger Finger
A study testing One cortisone injection and Two cortisone Injections in people with Stenosing Tenosynovitis and Trigger Finger, run by Rothman Institute Orthopaedics at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stenosing Tenosynovitis, Trigger Finger
- What is being tested?
- One cortisone injection and Two cortisone Injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2009to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is greater than 18 years of age, presenting with stenosing tenosynovitis.
- Subject is willing and able to provide informed consent.
Who cannot join
- Patients who have previously undergone surgery for the treatment of trigger finger.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Rothman Institute: Egg Harbor Township Location
Egg Harbor, New Jersey, 08234
Emran Sheikh, MD
- Recruiting
Rothman Institute: Manahawkin location
Manahawkin, New Jersey, 08050
Emran Sheikh, MD
- Recruiting
Rothman Institute: Media location
Media, Pennsylvania, 19063
Pedro Berendjiklian, MD
- Recruiting
Rothman Institute Center City Location
Philadelphia, Pennsylvania, 19107
Charles Leinberry, MD
Pedro Beredjiklian, MD
- Recruiting
Rothman Institute, South Philadelphia Location
Philadelphia, Pennsylvania, 19145
Charles Leinberry, MD
- Recruiting
Rothman Institute, Northeast Philadelphia location
Philadelphia, Pennsylvania, 19152
Charles Leinberry, MD
- Recruiting
Rothman Institute: Vorhees location
Vorhees, New Jersey, 08043
Pedro Berendjiklian, MD
About this study
Official title: A Prospective, Randomized Study Comparing One vs. Two Cortisone Injections for Trigger Finger
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.
- Conditions
- Stenosing Tenosynovitis, Trigger Finger
- Being tested
- One cortisone injection, Two cortisone Injections
- Keywords
- Trigger Finger, Trigger Thumb
- Medical subject headings
- Tendon Entrapment, Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One cortisone injectionDrug
Patients in this arm will receive one cortisone injection for the treatment of his/her symptoms
Two cortisone InjectionsDrug
Subjects randomized to this treatment will receive two cortisone injections, 4-6 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| One injection | Active comparator | Not described Receives: Drug: One cortisone injection |
| Two Injections | Active comparator | Not described Receives: Drug: Two cortisone Injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenosing TenosynovitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Investigators
- Charles Leinberry, MD, Principal investigator, Rothman InstitutePedro Beredjiklian, MD, Principal investigator, Rothman InstituteEmran Sheikh, MD, Principal investigator, Rothman Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951236
- Sponsor's protocol ID
- RIUCLEI 09-01
- Status last verified
- Feb 2014
- First submitted
- 31 Jul 2009
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study Comparing One vs. Two Cortisone Injections for Trigger Finger
- ClinicalTrials.gov ID
- NCT00951236
- Acronym / sponsor ID
- RIUCLEI 09-01
- Conditions
- Stenosing Tenosynovitis, Trigger Finger
- Keywords
- Trigger Finger, Trigger Thumb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- May 2009
- First posted
- 4 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One injection | Active comparator | Drug: One cortisone injection |
| Two Injections | Active comparator | Drug: Two cortisone Injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is greater than 18 years of age, presenting with stenosing tenosynovitis.
- Subject is willing and able to provide informed consent.
Key exclusion criteria (1 listed)
- Patients who have previously undergone surgery for the treatment of trigger finger.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One cortisone injectionPatients in this arm will receive one cortisone injection for the treatment of his/her symptoms | Drug | One injection |
| Two cortisone InjectionsSubjects randomized to this treatment will receive two cortisone injections, 4-6 weeks apart | Drug | Two Injections |
Primary outcome
To determine if there is a difference in the incidence of pain, stiffness, clicking or locking at 6 months following final injection
3 secondary outcomes
To evaluate treatment response among diabetic patients
To evaluate treatment response between thumbs and fingers
To evaluate treatment response between nodular versus diffuse tenosynovitis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Leinberry, MD principal investigator
Rothman Institute
Pedro Beredjiklian, MD principal investigator
Rothman Institute
Emran Sheikh, MD principal investigator
Rothman Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One cortisone injection and Two cortisone Injections in people with Stenosing Tenosynovitis and Trigger Finger, run by Rothman Institute Orthopaedics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles Leinberry, MD (267-339-3677, charlie.leinberry@rothmaninstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if there is a difference in the incidence of pain, stiffness, clicking or locking at 6 months following final injection. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2014.