Vibratory Anesthesia in Trigger Finger Injections

NCT05405452 | Unknown Phase 4 FDA Drug FDA Device

• 1 other identifier: STUDY00001135
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Trigger Finger; Pain; Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

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.

Device: Vibration Anesthesia Device by Blaine Labs

Interventions

Vibration Anesthesia Device by Blaine Labs DEVICE

Device which vibrates on top of skin

Vibration

Gebauers Ethyl Chloride 100% Topical Spray DRUG

Sterile ethyl chloride spray

Also known as: P/N 0386-0001-03

Topical coolant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Adult
• Diagnosed with trigger finger
• Warrants a trigger finger injection

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (2)

Banner UMC North Hills Clinic

Tucson, Arizona, 85704, United States

RECRUITING

Banner University Alvernon Clinic

Tucson, Arizona, 85711, United States

RECRUITING

Related Publications (15)

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

  BACKGROUND

• 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.

  PMID: 1880372 BACKGROUND

• 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.

  PMID: 17950222 BACKGROUND

• 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.

  PMID: 19468879 BACKGROUND

• 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.

  PMID: 31268729 BACKGROUND

• 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.

  PMID: 29290504 BACKGROUND

• 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.

  PMID: 23205235 BACKGROUND

• 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.

  PMID: 25410501 BACKGROUND

• 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.

  PMID: 28259274 BACKGROUND

• 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.

  PMID: 23034364 BACKGROUND

• 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.

  PMID: 22001341 BACKGROUND

• 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.

  PMID: 19473149 BACKGROUND

• 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.

  PMID: 25810837 BACKGROUND

• 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.

  PMID: 28244902 BACKGROUND

• 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.

  PMID: 15530291 BACKGROUND

MeSH Terms

Conditions

Trigger Finger Disorder; Pain

Interventions

Ethyl Chloride

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals

Study Officials

• Tolga Turker, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joey F Ghotmi, BS

CONTACT

5202486350; joeyghotmi@email.arizona.edu

Tolga Turker, MD

CONTACT

(520) 626-4024; tolgaturker@email.arizona.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 6, 2022
• Study Start: August 14, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)