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Vibratory Anesthesia in Trigger Finger Injections

Primary Purpose

Trigger Finger, Pain, Anesthesia, Local

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Vibration Anesthesia Device by Blaine Labs

Gebauers Ethyl Chloride 100% Topical Spray

About this trial

This is an interventional other trial for Trigger Finger

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Banner UMC North Hills ClinicRecruiting
Banner University Alvernon ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

No topical anesthesia

Topical coolant

Vibration

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT05405452

First Posted

May 31, 2022

Last Updated

August 14, 2023

Sponsor

University of Arizona

1. Study Identification

Unique Protocol Identification Number

NCT05405452

Brief Title

Vibratory Anesthesia in Trigger Finger Injections

Official Title

Investigation of the Effectiveness of Vibratory Stimulus in Trigger Finger Injections

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 14, 2023 (Actual)

Primary Completion Date

August 1, 2025 (Anticipated)

Study Completion Date

August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trigger Finger, Pain, Anesthesia, Local

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

No topical anesthesia

Arm Type

No Intervention

Arm Description

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

Arm Title

Topical coolant

Arm Type

Experimental

Arm Description

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.

Arm Title

Vibration

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Vibration Anesthesia Device by Blaine Labs

Intervention Description

Device which vibrates on top of skin

Intervention Type

Drug

Intervention Name(s)

Gebauers Ethyl Chloride 100% Topical Spray

Other Intervention Name(s)

P/N 0386-0001-03

Intervention Description

Sterile ethyl chloride spray

Primary Outcome Measure Information:

Title

Pain Felt

Description

Time Frame

Immediately after the trigger finger injection is completed

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joey F Ghotmi, BS

Phone

5202486350

joeyghotmi@email.arizona.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Tolga Turker, MD

Phone

(520) 626-4024

tolgaturker@email.arizona.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tolga Turker, MD

Organizational Affiliation

Associate Professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Banner UMC North Hills Clinic

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Individual Site Status

Recruiting

Facility Contact:

Phone

520-694-8888

Facility Name

Banner University Alvernon Clinic

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85711

Country

United States

Individual Site Status

Recruiting

Facility Contact:

Phone

520-694-8888

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

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

Results Reference

background

PubMed Identifier

1880372

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.

Results Reference

background

PubMed Identifier

17950222

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.

Results Reference

background

PubMed Identifier

19468879

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.

Results Reference

background

PubMed Identifier

31268729

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.

Results Reference

background

PubMed Identifier

29290504

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.

Results Reference

background

PubMed Identifier

23205235

Citation

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.

Results Reference

background

PubMed Identifier

25410501

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.

Results Reference

background

PubMed Identifier

28259274

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.

Results Reference

background

PubMed Identifier

23034364

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.

Results Reference

background

PubMed Identifier

22001341

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.

Results Reference

background

PubMed Identifier

19473149

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.

Results Reference

background

PubMed Identifier

25810837

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.

Results Reference

background

PubMed Identifier

28244902

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.

Results Reference

background

PubMed Identifier

15530291

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.

Results Reference

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Vibratory Anesthesia in Trigger Finger Injections

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