Trigger FingerPhase 4NCT05405452
Vibratory Anesthesia in Trigger Finger Injections
A Phase 4 study testing Vibration Anesthesia Device by Blaine Labs and Gebauers Ethyl Chloride 100% Topical Spray in people with Trigger Finger and Pain, run by University of Arizona at 2 sites in United States.
Trial summary
This study aims to compare the effectiveness of the use of no topical anesthesia, topical coolant, and the use of vibration in the reduction of pain during trigger finger injections. 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, Pain, Anesthesia, Local
- What is being tested?
- Vibration Anesthesia Device by Blaine Labs and Gebauers Ethyl Chloride 100% Topical Spray
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Aug 2023to 1 Aug 2025
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Adult
- Diagnosed with trigger finger
- Warrants a trigger finger injection
Who cannot join
- Subjects with known decreased light touch sensation in the territory of the trigger finger injection.
- Not diagnosed with trigger finger or does not warrant a trigger finger injection per the typical treatment algorithm adopted by the attending physician.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Banner UMC North Hills Clinic
Tucson, Arizona, 85704
520-694-8888
- Recruiting
Banner University Alvernon Clinic
Tucson, Arizona, 85711
520-694-8888
About this study
Official title: Investigation of the Effectiveness of Vibratory Stimulus in Trigger Finger Injections
This study aims to compare the effectiveness of the use of no topical anesthesia, topical coolant, and the use of vibration in the reduction of pain during trigger finger injections. This will be done by randomizing patients who are diagnosed with trigger finger, warrant and choose to continue with a steroid injection into each of the respective anesthetic (or lack thereof) methods described. After conducting this and gathering data on the subjects pain felt, we will compare the analgesia from each of the anesthetic methods.
- Conditions
- Trigger Finger, Pain, Anesthesia, Local
- Being tested
- Vibration Anesthesia Device by Blaine Labs, Gebauers Ethyl Chloride 100% Topical Spray
- Medical subject headings
- Trigger Finger Disorder, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration Anesthesia Device by Blaine LabsDevice
Device which vibrates on top of skin
Gebauers Ethyl Chloride 100% Topical SprayDrug
Also called P/N 0386-0001-03
Sterile ethyl chloride spray
| Study group | Role | What they receive |
|---|---|---|
| No topical anesthesia | No intervention | No topical anesthesia will be given during the trigger finger injection. |
| Topical coolant | Experimental | The subject will have 5 seconds of sterile ethyl chloride sprayed at the site of the trigger finger injections just prior to the administration of the injection. Receives: Drug: Gebauers Ethyl Chloride 100% Topical Spray |
| Vibration | Experimental | The subject will have a vibration device placed just proximal to the site of the trigger finger injection concurrent with the administration of the injection. Receives: Device: Vibration Anesthesia Device by Blaine Labs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Felt
Visual Analog Pain Scale Rating (Hayes and Patterson 1921)
Scale Title: Pain scale Maximum Value: 10 - The worst pain Minimum value: 0 - No pain
*A lower number indicates a better outcome (less pain felt).
Measured: Immediately after the trigger finger injection is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start14 Aug 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Trigger FingerStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tolga Turker, University of Arizona
- Investigators
- Tolga Turker, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405452
- Sponsor's protocol ID
- STUDY00001135
- Status last verified
- Aug 2023
- First submitted
- 31 May 2022
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Blazar, P. and R. Aggarwal, Trigger finger (stenosing flexor tenosynovitis). 2018.
Sampson SP, Badalamente MA, Hurst LC, Seidman J. Pathobiology of the human A1 pulley in trigger finger. J Hand Surg Am. 1991 Jul;16(4):714-21. doi: 10.1016/0363-5023(91)90200-u.
PubMed 1880372Sbernardori MC, Bandiera P. Histopathology of the A1 pulley in adult trigger fingers. J Hand Surg Eur Vol. 2007 Oct;32(5):556-9. doi: 10.1016/J.JHSE.2007.06.002. Epub 2007 Aug 7.
PubMed 17950222Makkouk AH, Oetgen ME, Swigart CR, Dodds SD. Trigger finger: etiology, evaluation, and treatment. Curr Rev Musculoskelet Med. 2008 Jun;1(2):92-6. doi: 10.1007/s12178-007-9012-1.
PubMed 19468879Petchprapa CN, Vaswani D. MRI of the Fingers: An Update. AJR Am J Roentgenol. 2019 Sep;213(3):534-548. doi: 10.2214/AJR.19.21217. Epub 2019 Jul 3.
PubMed 31268729Lunsford D, Valdes K, Hengy S. Conservative management of trigger finger: A systematic review. J Hand Ther. 2019 Apr-Jun;32(2):212-221. doi: 10.1016/j.jht.2017.10.016. Epub 2017 Dec 28.
PubMed 29290504Dala-Ali BM, Nakhdjevani A, Lloyd MA, Schreuder FB. The efficacy of steroid injection in the treatment of trigger finger. Clin Orthop Surg. 2012 Dec;4(4):263-8. doi: 10.4055/cios.2012.4.4.263. Epub 2012 Nov 16.
PubMed 23205235Wojahn RD, Foeger NC, Gelberman RH, Calfee RP. Long-term outcomes following a single corticosteroid injection for trigger finger. J Bone Joint Surg Am. 2014 Nov 19;96(22):1849-54. doi: 10.2106/JBJS.N.00004.
PubMed 25410501Franko OI, Stern PJ. Use and Effectiveness of Ethyl Chloride for Hand Injections. J Hand Surg Am. 2017 Mar;42(3):175-181.e1. doi: 10.1016/j.jhsa.2016.12.013.
PubMed 28259274Moayedi M, Davis KD. Theories of pain: from specificity to gate control. J Neurophysiol. 2013 Jan;109(1):5-12. doi: 10.1152/jn.00457.2012. Epub 2012 Oct 3.
PubMed 23034364Sharma P, Czyz CN, Wulc AE. Investigating the efficacy of vibration anesthesia to reduce pain from cosmetic botulinum toxin injections. Aesthet Surg J. 2011 Nov;31(8):966-71. doi: 10.1177/1090820X11422809. Epub 2011 Oct 14.
PubMed 22001341Nanitsos E, Vartuli R, Forte A, Dennison PJ, Peck CC. The effect of vibration on pain during local anaesthesia injections. Aust Dent J. 2009 Jun;54(2):94-100. doi: 10.1111/j.1834-7819.2009.01100.x.
PubMed 19473149Nasehi A, Bhardwaj S, Kamath AT, Gadicherla S, Pentapati KC. Clinical pain evaluation with intraoral vibration device during local anesthetic injections. J Clin Exp Dent. 2015 Feb 1;7(1):e23-7. doi: 10.4317/jced.51643. eCollection 2015 Feb.
PubMed 25810837Park KY, Lee Y, Hong JY, Chung WS, Kim MN, Kim BJ. Vibration Anesthesia for Pain Reduction During Intralesional Steroid Injection for Keloid Treatment. Dermatol Surg. 2017 May;43(5):724-727. doi: 10.1097/DSS.0000000000001040.
PubMed 28244902Smith KC, Comite SL, Balasubramanian S, Carver A, Liu JF. Vibration anesthesia: a noninvasive method of reducing discomfort prior to dermatologic procedures. Dermatol Online J. 2004 Oct 15;10(2):1.
PubMed 15530291
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Vibratory Stimulus in Trigger Finger Injections
- ClinicalTrials.gov ID
- NCT05405452
- Acronym / sponsor ID
- STUDY00001135
- Conditions
- Trigger Finger, Pain, Anesthesia, Local
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 6 Jun 2022 (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.
This study aims to compare the effectiveness of the use of no topical anesthesia, topical coolant, and the use of vibration in the reduction of pain during trigger finger injections. This will be done by randomizing patients who are diagnosed with trigger finger, warrant and choose to continue with a steroid injection into each of the respective anesthetic (or lack thereof) methods described. After conducting this and gathering data on the subjects pain felt, we will compare the analgesia from each of the anesthetic methods.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No topical anesthesia | No intervention | –No topical anesthesia will be given during the trigger finger injection. |
| Topical coolant | Experimental | Drug: Gebauers Ethyl Chloride 100% Topical SprayThe subject will have 5 seconds of sterile ethyl chloride sprayed at the site of the trigger finger injections just prior to the administration of the injection. |
| Vibration | Experimental | Device: Vibration Anesthesia Device by Blaine LabsThe subject will have a vibration device placed just proximal to the site of the trigger finger injection concurrent with the administration of the injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy Adult
- Diagnosed with trigger finger
- Warrants a trigger finger injection
Key exclusion criteria (2 listed)
- Subjects with known decreased light touch sensation in the territory of the trigger finger injection.
- Not diagnosed with trigger finger or does not warrant a trigger finger injection per the typical treatment algorithm adopted by the attending physician.
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 |
|---|---|---|
| Vibration Anesthesia Device by Blaine LabsDevice which vibrates on top of skin | Device | Vibration |
| Gebauers Ethyl Chloride 100% Topical SprayAlso: P/N 0386-0001-03Sterile ethyl chloride spray | Drug | Topical coolant |
Primary outcome
Pain Felt
Time frame: Immediately after the trigger finger injection is completed
Visual Analog Pain Scale Rating (Hayes and Patterson 1921) Scale Title: Pain scale Maximum Value: 10 - The worst pain Minimum value: 0 - No pain *A lower number indicates a better outcome (less pain felt).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- BackgroundBlazar, P. and R. Aggarwal, Trigger finger (stenosing flexor tenosynovitis). 2018.
- Background: PubMed 1880372Sampson SP, Badalamente MA, Hurst LC, Seidman J. Pathobiology of the human A1 pulley in trigger finger. J Hand Surg Am. 1991 Jul;16(4):714-21. doi: 10.1016/0363-5023(91)90200-u.
- Background: PubMed 17950222Sbernardori MC, Bandiera P. Histopathology of the A1 pulley in adult trigger fingers. J Hand Surg Eur Vol. 2007 Oct;32(5):556-9. doi: 10.1016/J.JHSE.2007.06.002. Epub 2007 Aug 7.
- Background: PubMed 19468879Makkouk AH, Oetgen ME, Swigart CR, Dodds SD. Trigger finger: etiology, evaluation, and treatment. Curr Rev Musculoskelet Med. 2008 Jun;1(2):92-6. doi: 10.1007/s12178-007-9012-1.
- Background: PubMed 31268729Petchprapa CN, Vaswani D. MRI of the Fingers: An Update. AJR Am J Roentgenol. 2019 Sep;213(3):534-548. doi: 10.2214/AJR.19.21217. Epub 2019 Jul 3.
- Background: PubMed 29290504Lunsford D, Valdes K, Hengy S. Conservative management of trigger finger: A systematic review. J Hand Ther. 2019 Apr-Jun;32(2):212-221. doi: 10.1016/j.jht.2017.10.016. Epub 2017 Dec 28.
- Background: PubMed 23205235Dala-Ali BM, Nakhdjevani A, Lloyd MA, Schreuder FB. The efficacy of steroid injection in the treatment of trigger finger. Clin Orthop Surg. 2012 Dec;4(4):263-8. doi: 10.4055/cios.2012.4.4.263. Epub 2012 Nov 16.
- Background: PubMed 25410501Wojahn RD, Foeger NC, Gelberman RH, Calfee RP. Long-term outcomes following a single corticosteroid injection for trigger finger. J Bone Joint Surg Am. 2014 Nov 19;96(22):1849-54. doi: 10.2106/JBJS.N.00004.
- Background: PubMed 28259274Franko OI, Stern PJ. Use and Effectiveness of Ethyl Chloride for Hand Injections. J Hand Surg Am. 2017 Mar;42(3):175-181.e1. doi: 10.1016/j.jhsa.2016.12.013.
- Background: PubMed 23034364Moayedi M, Davis KD. Theories of pain: from specificity to gate control. J Neurophysiol. 2013 Jan;109(1):5-12. doi: 10.1152/jn.00457.2012. Epub 2012 Oct 3.
- Background: PubMed 22001341Sharma P, Czyz CN, Wulc AE. Investigating the efficacy of vibration anesthesia to reduce pain from cosmetic botulinum toxin injections. Aesthet Surg J. 2011 Nov;31(8):966-71. doi: 10.1177/1090820X11422809. Epub 2011 Oct 14.
- Background: PubMed 19473149Nanitsos E, Vartuli R, Forte A, Dennison PJ, Peck CC. The effect of vibration on pain during local anaesthesia injections. Aust Dent J. 2009 Jun;54(2):94-100. doi: 10.1111/j.1834-7819.2009.01100.x.
- Individual participant dataSharing planned: No
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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.
Tolga Turker, MD principal investigator
Associate Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vibration Anesthesia Device by Blaine Labs and Gebauers Ethyl Chloride 100% Topical Spray in people with Trigger Finger and Pain, run by University of Arizona at 2 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 3 inclusion and 2 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 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joey F Ghotmi, BS (5202486350, joeyghotmi@email.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Felt (time frame: Immediately after the trigger finger injection is completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05405452, which also lists 15 linked publications.
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 Aug 2023.