Clinical trial NCT04023695
Conditions: Trigger Finger
Sponsor: Vanderbilt University Medical Center
Start date: 2017-10-01; Completion date: 2018-08-30
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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

Arms: arm 1: This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine arm 2: 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.
Interventions: intervention 1: Corticosteroid with lidocaine with epinephrine intervention 2: Corticosteroid with normal saline
Intervention descriptions: intervention 1: Trigger finger injection intervention 2: Trigger finger injection

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
 
 
 
 
 
Trigger finger corticosteroid injection with and without lidocaine with epineph-
rine; a randomized, double blind controlled trial 
CT Number: 1064521-12 
 
Principal Investigator: Brian Drolet, MD 
Version Date: 8/27/2019 
 
 
 
 


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Abstract 
 
Objective: To determine if there is less pain from a corticosteroid injection with or without lido-
caine with epinephrine when pharmacologically treating trigger finger (stenosis tenosynovitis). 
Research Plan: The treatment of trigger finger involves an injection of corticosteroid (e.g., 40 
mg Kenalog). Kenalog treats the underlying inflammatory pathology.  Some surgeons add lido-
caine with epinephrine as a local anesthetic with the injection. Lidocaine with epinephrine is as-
sociated 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. This hypothesis is based on experience injecting 
without lidocaine with epinephrine (i.e., Kenalog only) in clinic. Comparison of these two meth-
ods has not been done previously. Patients presenting to our clinic with trigger finger will have 
the option to electively enroll in this study comparing the two methods. 
Methods: Patients will be randomized into two groups with randomizing software. The two 
groups will include (1) 1mL corticosteroid + 1mL Lidocaine with epinephrine vs (2) 1mL cortico-
steroid + 1mL saline. The surgeon (injector) will also be blinded to the selected treatment to 
avoid bias. The pain levels will be assessed at 1 minute after the injection using the VAS pain 
scale.  
 
 
 
 
 
 
 
 
 
 
 
 


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Contents 
Table of Contents: 
 
1. 
Introduction  
2. 
Objective and Hypothesis  
3. 
Study Procedures 
3.1. 
Study Design  
3.2. 
Data Points  
3.3. 
Study Risk  
3.4. 
Recruitment Methods  
3.5. 
Informed Consent Procedures 
3.6. 
Inclusion/Exclusion Criteria  
3.7. 
Data Analysis  
3.8. 
Withdrawal of Subjects  
4. 
Adverse Event Reporting 
5. 
Privacy and Confidentiality  
6. 
Communication Plan  
7. 
References 
8. 
Appendix 
 
 
 


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1. Introduction 
 
Trigger finger is a pathology of the flexor tendons in the fingers. Under normal physio-
logic conditions, the flexor tendon slides under a close-fitting tendon sheath when the finger ex-
tends or flexes. However, in some patients, the flexor tendon can become irritated and subse-
quently develop inflammatory nodules. When this happens, the nodules catch the tendon 
sheath during finger extension and flexion. This can causes pain and dysfunction.  
 
The treatment for trigger finger involves the injection of a corticosteroid to shrink the in-
flammatory nodule on the flexor tendon. Often, the injection involves a 50:50 mixture of local an-
esthetic and corticosteroids 5,6,7,8. The lidocaine with epinephrine component of the injection 
causes a burning sensation, which causes discomfort during the procedure.  Lidocaine with epi-
nephrine is not anti-inflammatory and does not treat the underlying pathology. To date, there are 
no formal studies that have compared the pain outcomes and long-term efficacy of using corti-
costeroids + lidocaine with epinephrine vs corticosteroid injections alone. 
 
Trigger finger is present in 3-5% of the general adult population, and up to 10% of dia-
betic patients 8, 9 This project hopes to establish a treatment method that is less painful and in-
volves fewer medications without sacrificing long-term efficacy. If this project yields significant 
results, it could change the practice of trigger injections on the national level, this would impact 
millions of patients.  
 
2. Objective and hypothesis 
The purpose of this study is to see if removing lidocaine with epinephrine from trigger finger in-
jections decreases pain of the shot without decreasing the effectiveness of the treatment. We 
hypothesize that using an injection of corticosteroids (without lidocaine with epinephrine) will re-
duce the of treatment.  
3. Study Procedures 
3.1 Study Design 
This study will be a prospective randomized control trial. The study will also be double blind, as 
the patient and physician will not know which injection is being used. Both interventions (Kena-
log + Lidocaine with epinephrine and Kenalog alone) can be classified as standard of care, as 
they are already being used in our clinic and by surgeons around the world in a similar fashion. 
Syringes will be pre-filled by the study personnel with either: 
1.     1mL 1% lidocaine with epinephrine with epinephrine and 1ml of Kenalog 40 (2 mL total) 


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2.     1mL of 0.9% saline and 1ml of Kenalog 40 (2 mL total) 
Patients will have an equal (50% chance) of receiving either injection that will be determined by 
using randomizer software. 
3.2 Data points  
We will keep track of the following:  
- Patient identification (medical record number) 
- Age 
- Gender 
- Type of Injection 
- Date of injection 
- Digit/Hand 
- Reported Pain Score at 1 minute 
- Adverse effects of injection (infection, skin pigmentation, atrophy) 
We will also be keeping track of the following comorbid conditions to better analyze our data:  
- Diabetes (insulin dependent, non-insulin dependent) 
- Hypothyroidism 
- Chronic opioid use 
- Smoking history  
- Carpal tunnel syndrome 
- Rheumatologic conditions  
 
3.3 Study Risk  
This study is categorized as less than minimal risk.  We are comparing two treatment methods 
that are accepted as standard of care, and are already used on the clinic population being stud-
ied on a daily basis.  There is no new experimental intervention that would put patients at 
greater than minimal risk 
To minimize procedural risks, an experienced clinician will perform all injections. A standardized 
procedure will also be used for each injection. There will be a timeout before each procedure to 


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ensure all information is correct and accurate. The skin surrounding the injection site will be 
throughout cleaned with rubbing alcohol to minimize the risk of infection. 
3.4 Informed Consent Procedures 
Informed consent will be obtained before performing any procedures. The Principle Investigator 
or Co-investigator will be obtaining informed consent. All study personnel have successfully 
completed human subjects training.  
3.5 Inclusion/Exclusion Criteria 
Inclusion Criteria: 
- >18 years 
Exclusion Criteria: 
- Unconsentable 
- Not a candidate for injections 
3.6 Statistical Analysis 
We are planning a study of a continuous response variable from independent control and exper-
imental subjects with 1.1538 control(s) per experimental subject.  In a previous study the re-
sponse within each subject group was normally distributed with standard deviation 0.3.  If the 
true difference in the experimental and control means is 0.2, we will need to study 34 experi-
mental subjects and 39 control subjects to be able to reject the null hypothesis that the popula-
tion means of the experimental and control groups are equal with probability (power) 0.8. The 
Type I error probability associated with this test of this null hypothesis is 0.05. 
Demographic data and adverse events will be assessed with the chi-square analysis.  
Pain scores will be assessed with the Manny-Whitney U test. 
3.7   Withdrawal of Subjects 
There are no anticipated circumstances under which subjects would be withdrawn from re-
search without their consent. If subjects withdraw, there will be no penalty or consequences.  
 
4. Adverse Reporting 


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Adverse events will be reported to the IRB immediately through standard reporting mechanisms.  
The attending surgeon will be involved with the post-care along with any necessary physician 
staff. 
5. Privacy and Confidentiality 
Private health information (PHI) will used in the study, but not disclosed. All PHI will be stored 
on a secure, password-locked server. All participants in the study have obtained Human Re-
search certification to have the necessary authorization to PHI. When collecting patient data, 
only medical record numbers will be used to identify patients.   
6. Communication Plan 
Reporting will occur through standard process for the IRB.  There is one clinic at a single site 
performing this study.  
7. References 
1. Rhoades CE, Gelberman RH, Manjarris JF. Stenosing tenosynovitis of the fingers and thumb. 
Results of a prospective trial of steroid injection and splinting. Clin Orthop Relat 
Res.1984;190:236e238. 
2. Clark DD, Ricker JH, MacCollum MS. The efficacy of local steroid injection in the treatment of 
stenosing tenovaginitis. Plast Reconstr Surg. 1973;51(2):179 -180. 
3. Dardas, Agnes Z., James Vandenberg, Tony Shen, Richard H. Gelberman, and Ryan P. 
Calfee. "Long-Term Effectiveness of Repeat Corticosteroid Injections for Trigger Finger." The 
Journal of Hand Surgery 42.4 (2017): 227-35. 
4. Moore JS. Flexor tendon entrapment of the digits (trigger ﬁnger and trigger thumb). The Jour-
nal of Occupational and Environmental Medicine 2000;42(5):526–45. 
5. T. Rozental, D. Zurakowski, P. BlazarTrigger finger: prognostic indicators of recurrence fol-
lowing corticosteroid injection J Bone Jt Surg Am, 90 (8) (2008), pp. 1665–1672. 
6. Sheikh, Emran et al. “A Prospective Randomized Trial Comparing the Effectiveness of One 
versus Two (staged) Corticosteroid Injections for the Treatment of Stenosing Tenosynovitis.” 
Hand (New York, N.Y.) 9.3 (2014): 340–345. PMC 
7. Julka, Abhishek, Ana-Maria Vranceanu, Apurva S. Shah, Frank Peters, and David Ring. "Pre-
dictors of Pain During and the Day After Corticosteroid Injection for Idiopathic Trigger Finger." 
The Journal of Hand Surgery 37.2 (2012): 237-42. 


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8. Wojahn, Robert D. et al. “Long-Term Outcomes Following a Single Corticosteroid Injection for 
Trigger Finger.” The Journal of Bone and Joint Surgery. American volume 96.22 (2014): 1849–
1854 
9. Peters-Veluthamaningal C, van der Windt DA, Winters JC, Meyboom-de Jong B. Corticoste-
roid injection for trigger finger in adults. Cochrane Database Sys Rev. 2009:CD005617 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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8.    Appendix  
Appendix Item 1: Green’s Classification of Trigger Finger Severity  
 
Appendix Item 2: VAS Pain Score