Trigger FingerPhase 1NCT03445780
Comparison of Distraction Methods for Pain Relief of Trigger Finger Injection
A Phase 1 study testing Ethyl chloride spray, Pinching and No Site of Procedure in people with Trigger Finger, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the best distraction mechanism during trigger finger injection in the outpatient setting. Temporary discomfort from the needle prick is highly feared by patients and is often accompanied by significant acute pain and distress during routine corticosteroid injection in the… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Trigger Finger
- What is being tested?
- Ethyl chloride spray, Pinching and No Site of Procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2019to Apr 2020
- Phase
- Phase 1
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Trigger Finger
Who cannot join
- Allergies to lidocaine, betamethasone, infection, pregnancy, 3 prior injection to the digit
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
The purpose of this study is to evaluate the best distraction mechanism during trigger finger injection in the outpatient setting. Temporary discomfort from the needle prick is highly feared by patients and is often accompanied by significant acute pain and distress during routine corticosteroid injection in the orthopedic outpatient setting. This study aims to examine 4 different distraction methods and their efficacy in reducing perceived pain, which will be evaluate using the VAS (visual analog pain score.) The three distraction methods will be ethyl chloride spray, adjacent pinch, ethyl chloride spray and pinch, and "screen" or looking away method.
- Conditions
- Trigger Finger
- Being tested
- Ethyl chloride spray, Pinching, No Site of Procedure
- 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.
Ethyl chloride sprayDrug
Also called Bethamethasone
Skin cooling with ethyl chloride spray 5 seconds prior to injection
PinchingProcedure or surgery
Skin between the distal palmar crease and the palmo digital crease will be pinched for 5 seconds prior to injection
No Site of ProcedureProcedure or surgery
Subjects will sit behind a screen with a small opening large enough to introduce the injected hand. They will not see any of the procedure
| Study group | Role | What they receive |
|---|---|---|
| First Group | Experimental | Skin cooling with ethyl chloride spray will be used for 5 seconds prior to injection Receives: Drug: Ethyl chloride spray |
| Second Group | Experimental | The skin between the distal palmar crease and the palmo-digital crease and the palmo-digital crease will be pinched for 5 seconds prior to injection Receives: Procedure: Pinching |
| Third Group | Experimental | Skin cooling with ethyl chloride spray will be used for 5 seconds prior to injection as well as a second pinch to the skin between the distal palmar crease and the palmo digital crease Receives: Drug: Ethyl chloride spray; Procedure: Pinching |
| Fourth Group | Experimental | Subjects will sit behind a screen with a small opening large enough to introduce the injection hand. They will not see any of the procedure. Receives: Procedure: No Site of Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS) Score
A 10-cm scale will be shown to the patients, and they will be asked to choose the proper number, with 1 representing no pain and 10 symbolizing the most pain imaginable
Measured: 1 Minute, 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study startJun 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Why it stopped: No patients were enrolled; Senior author (Dr. Melamed) departed institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger FingerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eitan Melamed, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445780
- Sponsor's protocol ID
- 17-01275
- Status last verified
- Jan 2020
- First submitted
- 13 Feb 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Distraction Methods for Pain Relief of Trigger Finger Injection
- ClinicalTrials.gov ID
- NCT03445780
- Acronym / sponsor ID
- 17-01275
- Conditions
- Trigger Finger
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients were enrolled; Senior author (Dr. Melamed) departed institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 26 Feb 2018 (actual)
- 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.
The purpose of this study is to evaluate the best distraction mechanism during trigger finger injection in the outpatient setting. Temporary discomfort from the needle prick is highly feared by patients and is often accompanied by significant acute pain and distress during routine corticosteroid injection in the orthopedic outpatient setting. This study aims to examine 4 different distraction methods and their efficacy in reducing perceived pain, which will be evaluate using the VAS (visual analog pain score.) The three distraction methods will be ethyl chloride spray, adjacent pinch, ethyl chloride spray and pinch, and "screen" or looking away method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| First Group | Experimental | Drug: Ethyl chloride spraySkin cooling with ethyl chloride spray will be used for 5 seconds prior to injection |
| Second Group | Experimental | Procedure: PinchingThe skin between the distal palmar crease and the palmo-digital crease and the palmo-digital crease will be pinched for 5 seconds prior to injection |
| Third Group | Experimental | Drug: Ethyl chloride spray, Procedure: PinchingSkin cooling with ethyl chloride spray will be used for 5 seconds prior to injection as well as a second pinch to the skin between the distal palmar crease and the palmo digital crease |
| Fourth Group | Experimental | Procedure: No Site of ProcedureSubjects will sit behind a screen with a small opening large enough to introduce the injection hand. They will not see any of the procedure. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Trigger Finger
Key exclusion criteria (1 listed)
- Allergies to lidocaine, betamethasone, infection, pregnancy, 3 prior injection to the digit
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 |
|---|---|---|
| Ethyl chloride sprayAlso: BethamethasoneSkin cooling with ethyl chloride spray 5 seconds prior to injection | Drug | First Group, Third Group |
| PinchingSkin between the distal palmar crease and the palmo digital crease will be pinched for 5 seconds prior to injection | Procedure or surgery | Second Group, Third Group |
| No Site of ProcedureSubjects will sit behind a screen with a small opening large enough to introduce the injected hand. They will not see any of the procedure | Procedure or surgery | Fourth Group |
Primary outcome
Change in Visual Analog Scale (VAS) Score
Time frame: 1 Minute, 24 Hours
A 10-cm scale will be shown to the patients, and they will be asked to choose the proper number, with 1 representing no pain and 10 symbolizing the most pain imaginable
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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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.
Eitan Melamed, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ethyl chloride spray, Pinching and No Site of Procedure in people with Trigger Finger, run by NYU Langone Health 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 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: withdrawn, as of the sponsor's last update on 27 Jan 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Visual Analog Scale (VAS) Score (time frame: 1 Minute, 24 Hours). 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 27 Jan 2020.