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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05405452
Other study ID # STUDY00001135
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date August 14, 2023
Est. completion date August 1, 2025

Study information

Verified date August 2023
Source University of Arizona
Contact Joey F Ghotmi, BS
Phone 5202486350
Email joeyghotmi@email.arizona.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date August 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Healthy Adult - Diagnosed with trigger finger - Warrants a trigger finger injection Exclusion Criteria: - 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.

Study Design


Intervention

Device:
Vibration Anesthesia Device by Blaine Labs
Device which vibrates on top of skin
Drug:
Gebauers Ethyl Chloride 100% Topical Spray
Sterile ethyl chloride spray

Locations

Country Name City State
United States Banner UMC North Hills Clinic Tucson Arizona
United States Banner University Alvernon Clinic Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

References & Publications (15)

Blazar, P. and R. Aggarwal, Trigger finger (stenosing flexor tenosynovitis). 2018.

Dala-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. — View Citation

Franko 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. — View Citation

Lunsford 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. — View Citation

Makkouk 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. — View Citation

Moayedi 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. — View Citation

Nanitsos 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. — View Citation

Nasehi 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. — View Citation

Park 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. — View Citation

Petchprapa 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. — View Citation

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. — View Citation

Sbernardori 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. — View Citation

Sharma 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. — View Citation

Smith 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. — View Citation

Wojahn 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. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
Immediately after the trigger finger injection is completed
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