Vibratory Anesthesia in Trigger Finger Injections

August 14, 2023 updated by: Tolga Turker, University of Arizona

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • Banner UMC North Hills Clinic
        • Contact:
          • Phone Number: 520-694-8888
      • Tucson, Arizona, United States, 85711
        • Recruiting
        • Banner University Alvernon Clinic
        • Contact:
          • Phone Number: 520-694-8888

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No topical anesthesia
No topical anesthesia will be given during the trigger finger injection.
Experimental: 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.
Drug: Gebauers Ethyl Chloride 100% Topical Spray
Sterile ethyl chloride spray
Other Names:
  • P/N 0386-0001-03
Experimental: 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.
Device: Vibration Anesthesia Device by Blaine Labs
Device which vibrates on top of skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Immediately after the trigger finger injection is completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Principal Investigator: Tolga Turker, MD, Associate professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

May 31, 2022

First Submitted That Met QC Criteria

May 31, 2022

First Posted (Actual)

June 6, 2022

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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