Trigger Finger Corticosteroid Injection With and Without Local Anesthetic

NCT04023695 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1064521-12
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Trigger Finger

Outcome Measures

Primary Outcomes (2)

• Pain Outcome: Visual Analog Scale

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

  Assessed 1 minute after injection (in clinic)

• Pain Outcome: Visual Analog Scale

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

  Assessed after 24 hours after injection (by phone)

Study Arms (2)

Corticosteroid with lidocaine with epinephrine

ACTIVE COMPARATOR

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

Drug: Corticosteroid with lidocaine with epinephrine

Corticosteroid with normal saline

EXPERIMENTAL

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.

Drug: Corticosteroid with normal saline

Interventions

Corticosteroid with lidocaine with epinephrine DRUG

Trigger finger injection

Corticosteroid with lidocaine with epinephrine

Corticosteroid with normal saline DRUG

Trigger finger injection

Corticosteroid with normal saline

Eligibility Criteria

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

You may qualify if:

• At least 18 years old with trigger finger

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37235, United States

Location

MeSH Terms

Conditions

Trigger Finger Disorder

Interventions

Adrenal Cortex Hormones; Lidocaine; Epinephrine; Saline Solution

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Brian Drolet, MD
• Organization: Vanderbilt University

brian.c.drolet@vumc.org

(615) 322-2350

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Plastic Surgery

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 17, 2019
• Study Start: October 1, 2017
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: December 18, 2019
• Results First Posted: October 22, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)