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

• Sponsor: Ericka Lawler (Other)
• Overall Status: Completed
• CT.gov ID: NCT03641508
• Collaborator: (none)
• Enrollment: 69
• Location: 1
• Arms: 2
• Actual Duration (Months): 33
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trigger Finger Disorder	Drug: Triamcinolone; Drug: Dexamethasone	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 69 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Long Term Effectiveness of Trigger Finger Injections With Triamcinolone vs. Dexamethasone
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Triamcinolone The study drug used will be triamcinolone mixed with 1% lidocaine without epinephrine	Drug: Triamcinolone; Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble). This will be mixed with 1% lidocaine without epinephrine; Other Names: Kenalog
Active Comparator: Dexamethasone The study drug used will be dexamethasone mixed with 1% lidocaine without epinephrine	Drug: Dexamethasone; dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble). Again, this will be mixed with 1% lidocaine without epinephrine; Other Names: Decadron

Outcome Measures

Primary Outcome Measures

1. Number of Participants With no Symptoms of Trigger Finger [6 weeks]

   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.

2. Number of Participants With no Symptoms of Trigger Finger [6 months]

   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.

3. Number of Participants With no Symptoms of Trigger Finger [1 year]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

• Ericka Lawler

Investigators

• Principal Investigator: Ericka Lawler, MD, University of Iowa

Study Documents (Full-Text)

None provided.

More Information

Publications

• Freiberg A, Mulholland RS, Levine R. Nonoperative treatment of trigger fingers and thumbs. J Hand Surg Am. 1989 May;14(3):553-8.
• Griggs SM, Weiss AP, Lane LB, Schwenker C, Akelman E, Sachar K. Treatment of trigger finger in patients with diabetes mellitus. J Hand Surg Am. 1995 Sep;20(5):787-9.
• Lapidus PW, Guidotti FP. Stenosing tenovaginitis of the wrist and fingers. Clin Orthop Relat Res. 1972 Mar-Apr;83:87-90.
• Marks MR, Gunther SF. Efficacy of cortisone injection in treatment of trigger fingers and thumbs. J Hand Surg Am. 1989 Jul;14(4):722-7.
• Murphy D, Failla JM, Koniuch MP. Steroid versus placebo injection for trigger finger. J Hand Surg Am. 1995 Jul;20(4):628-31. Erratum in: J Hand Surg [Am] 1995 Nov;20(6):1075.
• Newport ML, Lane LB, Stuchin SA. Treatment of trigger finger by steroid injection. J Hand Surg Am. 1990 Sep;15(5):748-50.
• 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 Nov;(190):236-8.
• Ring D, Lozano-Calderón S, Shin R, Bastian P, Mudgal C, Jupiter J. A prospective randomized controlled trial of injection of dexamethasone versus triamcinolone for idiopathic trigger finger. J Hand Surg Am. 2008 Apr;33(4):516-22; discussion 523-4. doi: 10.1016/j.jhsa.2008.01.001.
• Stahl S, Kanter Y, Karnielli E. Outcome of trigger finger treatment in diabetes. J Diabetes Complications. 1997 Sep-Oct;11(5):287-90.
• Wolfe, Scott W. "Chapter 62-Tendinopathy." Green's Operative Hand Surgery, 6th Ed. Elsevier, Philadelphia. 2011.

• Responsible Party: Ericka Lawler, Principal Investigator, University of Iowa
• ClinicalTrials.gov Identifier: NCT03641508
• Other Study ID Numbers: 201308766
• First Posted: Aug 22, 2018
• Last Update Posted: May 31, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Ericka Lawler, Principal Investigator, University of Iowa: trigger finger
• Additional relevant MeSH terms: Trigger Finger Disorder; Dexamethasone; Triamcinolone

Study Results

Participant Flow

Arm/Group Title	Triamcinolone	Dexamethasone
Arm/Group Description	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	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
Period Title: First Injection
STARTED	37	32
COMPLETED	35	32
NOT COMPLETED	2	0
Period Title: First Injection
STARTED	2	10
COMPLETED	2	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Triamcinolone	Dexamethasone	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	37	32	69
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.4 (8.55)	63.7 (11.37)	61.94 (10.02)
Sex: Female, Male (Count of Participants)
Female	27 73%	26 81.3%	53 76.8%
Male	10 27%	6 18.8%	16 23.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	37 100%	32 100%	69 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With no Symptoms of Trigger Finger
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Triamcinolone	Dexamethasone
Arm/Group Description	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	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
Measure Participants	35	32
Count of Participants [Participants]	28 75.7%	9 28.1%

2. Primary Outcome

Title	Number of Participants With no Symptoms of Trigger Finger
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Triamcinolone	Dexamethasone
Arm/Group Description	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	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
Measure Participants	35	32
Count of Participants [Participants]	23 62.2%	12 37.5%

3. Primary Outcome

Title	Number of Participants With no Symptoms of Trigger Finger
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Triamcinolone	Dexamethasone
Arm/Group Description	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	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
Measure Participants	35	32
Count of Participants [Participants]	20 54.1%	13 40.6%

Adverse Events

Arm/Group Title	Triamcinolone		Dexamethasone
Arm/Group Description	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		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
All Cause Mortality
	Triamcinolone		Dexamethasone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Triamcinolone		Dexamethasone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Triamcinolone		Dexamethasone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/37 (27%)		7/32 (21.9%)
Musculoskeletal and connective tissue disorders
Transient numbness	8/37 (21.6%)	8	5/32 (15.6%)	5
Skin and subcutaneous tissue disorders
Pigment change	2/37 (5.4%)	2	2/32 (6.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.