Vibratory Anesthesia in Trigger Finger Injections

NCT ID: NCT05405452

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-14

Study Completion Date

2025-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Trigger Finger Pain Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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No topical anesthesia

No topical anesthesia will be given during the trigger finger injection.

Group Type NO_INTERVENTION

No interventions assigned to this group

Topical coolant

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.

Group Type EXPERIMENTAL

Gebauers Ethyl Chloride 100% Topical Spray

Intervention Type DRUG

Sterile ethyl chloride spray

Vibration

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.

Group Type EXPERIMENTAL

Vibration Anesthesia Device by Blaine Labs

Intervention Type DEVICE

Device which vibrates on top of skin

Interventions

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Vibration Anesthesia Device by Blaine Labs

Device which vibrates on top of skin

Intervention Type DEVICE

Gebauers Ethyl Chloride 100% Topical Spray

Sterile ethyl chloride spray

Intervention Type DRUG

Other Intervention Names

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P/N 0386-0001-03

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Tolga Turker

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tolga Turker, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Banner UMC North Hills Clinic

Tucson, Arizona, United States

Site Status RECRUITING

Banner University Alvernon Clinic

Tucson, Arizona, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joey F Ghotmi, BS

Role: CONTACT

5202486350

Tolga Turker, MD

Role: CONTACT

(520) 626-4024

Facility Contacts

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Role: primary

520-694-8888

Role: primary

520-694-8888

References

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 1880372 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17950222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19468879 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31268729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29290504 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23205235 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25410501 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28259274 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23034364 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22001341 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19473149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25810837 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28244902 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15530291 (View on PubMed)

Other Identifiers

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STUDY00001135

Identifier Type: -

Identifier Source: org_study_id

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