Back to results

Trigger Finger Corticosteroid Injection With and Without Local Anesthetic

Primary Purpose

Trigger Finger

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Corticosteroid with lidocaine with epinephrine

Corticosteroid with normal saline

About this trial

This is an interventional treatment trial for Trigger Finger

Eligibility Criteria

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

Inclusion Criteria:

At least 18 years old with trigger finger

Exclusion Criteria:

Preference for open trigger finger release
Not a candidate for corticosteroid injection
Contraindication to lidocaine with epinephrine

Sites / Locations

Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Corticosteroid with lidocaine with epinephrine

Corticosteroid with normal saline

Arm Description

This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine

This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine.

Outcomes

Primary Outcome Measures

Pain Outcome: Visual Analog Scale

Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever

Pain Outcome: Visual Analog Scale

Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever

Secondary Outcome Measures

Full Information

NCT ID

NCT04023695

First Posted

July 1, 2019

Last Updated

December 9, 2019

Sponsor

Vanderbilt University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04023695

Brief Title

Trigger Finger Corticosteroid Injection With and Without Local Anesthetic

Official Title

Trigger Finger Corticosteroid Injection With and Without Local Anesthetic; a Randomized, Double Blind Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

October 1, 2017 (Actual)

Primary Completion Date

August 30, 2018 (Actual)

Study Completion Date

August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Steroid injection is the first line treatment for trigger finger. Steroid injection is sometimes mixed with a local anesthetic.

Detailed Description

The treatment of trigger finger involves an injection of corticosteroid. Corticosteroid treats the underlying inflammatory pathology. Some surgeons add lidocaine with epinephrine as a local anesthetic with the injection. Lidocaine with epinephrine is associated with a burning sensation and may be the primary pain associated with the injection. We hypothesize that a corticosteroid injection without lidocaine with epinephrine will be less painful, and equally effective in treating trigger finger

6. Conditions and Keywords

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

Trigger Finger

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Corticosteroid with lidocaine with epinephrine

Arm Type

Active Comparator

Arm Description

This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine

Arm Title

Corticosteroid with normal saline

Arm Type

Experimental

Arm Description

This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine.

Intervention Type

Drug

Intervention Name(s)

Corticosteroid with lidocaine with epinephrine

Intervention Description

Trigger finger injection

Intervention Type

Drug

Intervention Name(s)

Corticosteroid with normal saline

Intervention Description

Trigger finger injection

Primary Outcome Measure Information:

Title

Pain Outcome: Visual Analog Scale

Description

Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever

Time Frame

Assessed 1 minute after injection (in clinic)

Title

Pain Outcome: Visual Analog Scale

Description

Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever

Time Frame

Assessed after 24 hours after injection (by phone)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At least 18 years old with trigger finger Exclusion Criteria: Preference for open trigger finger release Not a candidate for corticosteroid injection Contraindication to lidocaine with epinephrine

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37235

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

IPD will not be shared with other researchers

Learn more about this trial

Trigger Finger Corticosteroid Injection With and Without Local Anesthetic

We'll reach out to this number within 24 hrs