Trigger FingerPhase 4NCT04023695
Trigger Finger Corticosteroid Injection With and Without Local Anesthetic
A Phase 4 study testing Corticosteroid with lidocaine with epinephrine and Corticosteroid with normal saline in people with Trigger Finger, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Steroid injection is the first line treatment for trigger finger. Steroid injection is sometimes mixed with a local anesthetic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trigger Finger
- What is being tested?
- Corticosteroid with lidocaine with epinephrine and Corticosteroid with normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 30 Aug 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old with trigger finger
Who cannot join
- Preference for open trigger finger release
- Not a candidate for corticosteroid injection
- Contraindication to lidocaine with epinephrine
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37235
About this study
Official title: Trigger Finger Corticosteroid Injection With and Without Local Anesthetic; a Randomized, Double Blind Controlled Trial
Steroid injection is the first line treatment for trigger finger. Steroid injection is sometimes mixed with a local anesthetic.
Read the detailed description
The treatment of trigger finger involves an injection of corticosteroid. Corticosteroid treats the underlying inflammatory pathology. Some surgeons add lidocaine with epinephrine as a local anesthetic with the injection. Lidocaine with epinephrine is associated with a burning sensation and may be the primary pain associated with the injection. We hypothesize that a corticosteroid injection without lidocaine with epinephrine will be less painful, and equally effective in treating trigger finger
- Conditions
- Trigger Finger
- Being tested
- Corticosteroid with lidocaine with epinephrine, Corticosteroid with normal saline
- Medical subject headings
- Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid with lidocaine with epinephrineDrug
Trigger finger injection
Corticosteroid with normal salineDrug
Trigger finger injection
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid with lidocaine with epinephrine | Active comparator | This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine Receives: Drug: Corticosteroid with lidocaine with epinephrine |
| Corticosteroid with normal saline | Experimental | This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine. Receives: Drug: Corticosteroid with normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Outcome: Visual Analog Scale
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Measured: Assessed 1 minute after injection (in clinic)
Pain Outcome: Visual Analog Scale
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Measured: Assessed after 24 hours after injection (by phone)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 Oct 2017
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trigger FingerStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Drolet, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023695
- Sponsor's protocol ID
- 1064521-12
- Status last verified
- Dec 2019
- First submitted
- 1 Jul 2019
- Last updated
- 18 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trigger Finger Corticosteroid Injection With and Without Local Anesthetic; a Randomized, Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT04023695
- Acronym / sponsor ID
- 1064521-12
- Conditions
- Trigger Finger
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 17 Jul 2019 (actual)
- Results
- Posted 22 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Steroid injection is the first line treatment for trigger finger. Steroid injection is sometimes mixed with a local anesthetic.
Detailed description
The treatment of trigger finger involves an injection of corticosteroid. Corticosteroid treats the underlying inflammatory pathology. Some surgeons add lidocaine with epinephrine as a local anesthetic with the injection. Lidocaine with epinephrine is associated with a burning sensation and may be the primary pain associated with the injection. We hypothesize that a corticosteroid injection without lidocaine with epinephrine will be less painful, and equally effective in treating trigger finger
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid with lidocaine with epinephrine | Active comparator | Drug: Corticosteroid with lidocaine with epinephrineThis arm includes an injection mixture of corticosteroid and lidocaine with epinephrine |
| Corticosteroid with normal saline | Experimental | Drug: Corticosteroid with normal salineThis arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least 18 years old with trigger finger
Key exclusion criteria (3 listed)
- Preference for open trigger finger release
- Not a candidate for corticosteroid injection
- Contraindication to lidocaine with epinephrine
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 |
|---|---|---|
| Corticosteroid with lidocaine with epinephrineTrigger finger injection | Drug | Corticosteroid with lidocaine with epinephrine |
| Corticosteroid with normal salineTrigger finger injection | Drug | Corticosteroid with normal saline |
Primary outcome
Pain Outcome: Visual Analog Scale
Time frame: Assessed 1 minute after injection (in clinic)
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Pain Outcome: Visual Analog Scale
Time frame: Assessed after 24 hours after injection (by phone)
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Corticosteroid with lidocaine with epinephrine and Corticosteroid with normal saline in people with Trigger Finger, run by Vanderbilt University Medical Center at 1 site 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Outcome: Visual Analog Scale (time frame: Assessed 1 minute after injection (in clinic)). The study lists 2 primary outcomes in all. 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 18 Dec 2019.