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Long Term Effectiveness of Trigger Finger Injections With Triamcinolone vs. Dexamethasone

Long Term Effectiveness of Trigger Finger Injections With Triamcinolone vs. Dexamethasone

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03641508
Enrollment
69
Registered
2018-08-22
Start date
2014-01-31
Completion date
2016-10-31
Last updated
2019-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trigger Finger Disorder

Keywords

trigger finger

Brief summary

Trigger finger (stenosing tenosynovitis) is a very common condition and in office treatment with corticosteroid injection is widely accepted to be first line treatment. Previous studies have reported resolution of triggering after injection at rates ranging from 50% to 93%. Many factors contribute to this variability, including duration of symptoms, presence of diabetes, etc. This study will be a single center, prospective, randomized control trial. Patients will be collected into two different cohorts. The main cohort will be of patients with primary, idiopathic trigger finger. A second cohort of patients with diabetes will also be collected for secondary study questions. Study procedures will include clinical examination of the patient, injection of trigger fingers with mix of local anesthetic and one of two steroids, possible repeat trigger finger injections, and if patients are so indicated, surgical treatment of the trigger finger. Surgical treatment is considered clinical care of these patients who have continued or recurrent symptoms and the surgical treatment would not be considered part of this study. During the study, patients will also fill out surveys about their symptoms. The study drugs used will be 1% lidocaine without epinephrine mixed with either triamcinolone or dexamethasone. These medications are FDA approved for injection treatment of acute non-specific tenosynovitis. This indication includes trigger finger which is also known as acute stenosing tenosynovitis. The package inserts listing the indications for use of these medications are included in the attachments portion of the IRB application.

Detailed description

Upon coming to a clinical visit, patients who are complaining of trigger finger will be asked if they would like to participate in a study. After finishing the consent process, patients who elect to participate will be randomized to one of the two steroid groups. All patients will complete an initial enrollment survey as well as a DASH score (Disabilities of the Arm, Shoulder, and Hand), and the Michigan Hand Questionnaire (MHQ). Each patient will be examined by one of the attending physicians or one of the experienced physician's assistants and their Quinnell grade of trigger finger will be documented. Injection will performed in a standardized fashion in clinic. Multiple trigger fingers in any one patient will be treated but patients will be randomized, not individual fingers. The most radial finger treated will be the one followed for outcome measures. Patients will have the option to be treated with a different medication if they require further injections. However, all patients and data will be analyzed in an intention to treat manner. Follow-up visits will be arranged at 6 weeks, 6 months, 1 year, and 2 years. At each follow-up visit, patients will again fill out the DASH score, MHQ, and a study-specific survey to evaluate outcome. In anticipation of the difficulty of obtaining a high follow-up rate at the 1 year and 2 year marks, the study-specific survey and the DASH and the MHQ may be administered to the patients over the phone or be sent an electronic version of the surveys. Additionally, these patients will also receive a written copy of the surveys via mail to complete and return. All patients will be followed for a total of 2 years after their latest injection. Most of these procedures are standard of care, the only research visits are the 1 and 2 year follow-up visits. Some patients with recurrent or continued symptoms may be indicated for surgical treatment of their trigger finger. Surgical treatment is considered clinical care of these patients who have continued or recurrent symptoms and the surgical treatment would not be considered part of this study. Data collected from the patient's medical record will include demographic information such as age, sex, birthdate. The investigators will also review whether the patient is currently taking any medications for the treatment of diabetes mellitus.

Interventions

DRUGTriamcinolone

Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble). This will be mixed with 1% lidocaine without epinephrine

DRUGDexamethasone

dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble). Again, this will be mixed with 1% lidocaine without epinephrine

Sponsors

Ericka Lawler
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* Newly diagnosed primary, idiopathic trigger finger(s) * Quinnell grade II or greater. * Patients must be 18 years of age or older

Exclusion criteria

* patients taking any diabetic medications. * any history of inflammatory or autoimmune arthritis * history of prior trauma to the tendon of the affected digit * pregnancy, and breast feeding

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With no Symptoms of Trigger Finger6 weeksNumber of participants with no symptoms of trigger finger 6 weeks after the initial encounter for both groups. Outcomes were determined clinically: The Quinnell grading system was used for objectively evaluating the trigger finger. This grading system is a scale of 0-4 for severity of triggering with 0 being no triggering.

Countries

United States

Participant flow

Participants by arm

ArmCount
Triamcinolone
The study drug used will be triamcinolone mixed with 1% lidocaine without epinephrine Triamcinolone: Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble). This will be mixed with 1% lidocaine without epinephrine
37
Dexamethasone
The study drug used will be dexamethasone mixed with 1% lidocaine without epinephrine Dexamethasone: dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble). Again, this will be mixed with 1% lidocaine without epinephrine
32
Total69

Withdrawals & dropouts

PeriodReasonFG000FG001
First InjectionLost to Follow-up20

Baseline characteristics

CharacteristicDexamethasoneTotalTriamcinolone
Age, Continuous63.7 years
STANDARD_DEVIATION 11.37
61.94 years
STANDARD_DEVIATION 10.02
60.4 years
STANDARD_DEVIATION 8.55
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
32 participants69 participants37 participants
Sex: Female, Male
Female
26 Participants53 Participants27 Participants
Sex: Female, Male
Male
6 Participants16 Participants10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
10 / 377 / 32
serious
Total, serious adverse events
0 / 370 / 32

Outcome results

Primary

Number of Participants With no Symptoms of Trigger Finger

Number of participants with no symptoms of trigger finger 6 weeks after the initial encounter for both groups. Outcomes were determined clinically: The Quinnell grading system was used for objectively evaluating the trigger finger. This grading system is a scale of 0-4 for severity of triggering with 0 being no triggering.

Time frame: 6 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TriamcinoloneNumber of Participants With no Symptoms of Trigger Finger28 Participants
DexamethasoneNumber of Participants With no Symptoms of Trigger Finger9 Participants
Primary

Number of Participants With no Symptoms of Trigger Finger

Number of participants with no symptoms of trigger finger 6 months after the initial encounter for both groups. Outcomes were determined clinically: The Quinnell grading system was used for objectively evaluating the trigger finger. This grading system is a scale of 0-4 for severity of triggering with 0 being no triggering.

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TriamcinoloneNumber of Participants With no Symptoms of Trigger Finger23 Participants
DexamethasoneNumber of Participants With no Symptoms of Trigger Finger12 Participants
Primary

Number of Participants With no Symptoms of Trigger Finger

Number of participants with no symptoms of trigger finger 1 year after the initial encounter for both groups. Outcomes were determined clinically: The Quinnell grading system was used for objectively evaluating the trigger finger. This grading system is a scale of 0-4 for severity of triggering with 0 being no triggering.

Time frame: 1 year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
TriamcinoloneNumber of Participants With no Symptoms of Trigger Finger20 Participants
DexamethasoneNumber of Participants With no Symptoms of Trigger Finger13 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026