- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04023695
Trigger Finger Corticosteroid Injection With and Without Local Anesthetic
December 9, 2019 updated by: Brian Drolet, Vanderbilt University Medical Center
Trigger Finger Corticosteroid Injection With and Without Local Anesthetic; a Randomized, Double Blind Controlled Trial
Steroid injection is the first line treatment for trigger finger.
Steroid injection is sometimes mixed with a local anesthetic.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
110
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 Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37235
- Vanderbilt University Medical Center
-
-
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
No
Genders Eligible for Study
All
Description
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
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Corticosteroid with lidocaine with epinephrine
This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine
|
Trigger finger injection
|
Experimental: Corticosteroid with normal saline
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.
|
Trigger finger injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Outcome: Visual Analog Scale
Time Frame: Assessed 1 minute after injection (in clinic)
|
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
Time Frame: Assessed after 24 hours after injection (by phone)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
October 1, 2017
Primary Completion (Actual)
August 30, 2018
Study Completion (Actual)
August 30, 2018
Study Registration Dates
First Submitted
July 1, 2019
First Submitted That Met QC Criteria
July 15, 2019
First Posted (Actual)
July 17, 2019
Study Record Updates
Last Update Posted (Actual)
December 18, 2019
Last Update Submitted That Met QC Criteria
December 9, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Muscular Diseases
- Tendinopathy
- Tendon Entrapment
- Trigger Finger Disorder
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Lidocaine
- Epinephrine
Other Study ID Numbers
- 1064521-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
IPD will not be shared with other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
Clinical Trials on Trigger Finger
-
Stanford UniversityTerminatedTrigger Finger | Trigger Finger Disorder | Trigger Thumb | Trigger Digit | Trigger Thumb, Left Thumb | Trigger Thumb, Right Thumb | Trigger Finger, Ring Finger | Trigger Finger, Index Finger | Trigger Finger, Middle Finger | Trigger Finger, Little Finger | Trigger Thumb, Unspecified Thumb | Trigger Finger, Unspecified...United States
-
Brigham and Women's HospitalCompletedTrigger FingerUnited States
-
National and Kapodistrian University of AthensCompletedSurgical Release of Ai Pulley Trigger Finger
-
Waikato HospitalEnrolling by invitation
-
Armed Police Force Hospital, NepalCompleted
-
Sorin Daniel IordacheCompleted
-
Sharp HealthCareUniversity of UtahCompleted
-
Ericka LawlerCompletedTrigger Finger DisorderUnited States
-
Beatriz Sernajoto Cristiani PedroFederal University of São PauloUnknown
-
Jeppe Lange, MDCompleted
Clinical Trials on Corticosteroid with lidocaine with epinephrine
-
Seoul Medical CenterCompletedSpinal Anesthesia | Total Knee Replacement ArthroplastyKorea, Republic of
-
Vanderbilt University Medical CenterCompletedPlaque Psoriasis | Morphea | Alopecia Areata | Acne | Lichen Planus | Keloid | Prurigo Nodularis | Hypertrophic Scar | Frontal Fibrosing Alopecia | Keratoacanthoma | Granuloma Annulare | Nummular Eczema | Lichen Simplex Chronicus | Lichen Plano-Pilaris | Epidermal Inclusion CystUnited States
-
Bispebjerg HospitalCompleted
-
University of MiamiCompletedBlepharoptosisUnited States
-
Loma Linda UniversityWithdrawnOsteoarthritis, KneeUnited States
-
Rehabilitace MUDr. Hasan Mezian s.r.o.UnknownCarpal Tunnel SyndromeCzechia
-
Timothy EkhlassiEnrolling by invitationPain | Dermatochalasis | Dermatochalasis of Eyelid | Dermatochalasis of Both Upper Eyelids | Dermatochalasis of Both Eyes | Dermatochalasis of Right Upper Eyelid | Dermatochalasis of Left Upper EyelidCanada
-
Scott and White Hospital & ClinicCompleted
-
Tusker MedicalCompletedHealthy VolunteerUnited States
-
Tel Aviv UniversitySheba Medical Center; Private practice, Dr. Malka AshkenaziUnknown