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

NCT03641508 | Completed Phase 4 Results

• 1 other identifier: 201308766
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigger Finger Disorder

Keywords

trigger finger

Outcome Measures

Primary Outcomes (3)

• 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.

  6 weeks

• 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.

  6 months

• 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.

  1 year

Study Arms (2)

Triamcinolone

ACTIVE COMPARATOR

The study drug used will be triamcinolone mixed with 1% lidocaine without epinephrine

Drug: Triamcinolone

Dexamethasone

ACTIVE COMPARATOR

The study drug used will be dexamethasone mixed with 1% lidocaine without epinephrine

Drug: Dexamethasone

Interventions

Triamcinolone DRUG

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

Also known as: Kenalog

Triamcinolone

Dexamethasone DRUG

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

Also known as: Decadron

Dexamethasone

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ericka Lawler: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (10)

• Freiberg A, Mulholland RS, Levine R. Nonoperative treatment of trigger fingers and thumbs. J Hand Surg Am. 1989 May;14(3):553-8. doi: 10.1016/s0363-5023(89)80024-3.

  PMID: 2738345 BACKGROUND

• 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. doi: 10.1016/S0363-5023(05)80432-0.

  PMID: 8522745 BACKGROUND

• Lapidus PW, Guidotti FP. Stenosing tenovaginitis of the wrist and fingers. Clin Orthop Relat Res. 1972 Mar-Apr;83:87-90. doi: 10.1097/00003086-197203000-00015. No abstract available.

  PMID: 5014835 BACKGROUND

• 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. doi: 10.1016/0363-5023(89)90199-8.

  PMID: 2754207 BACKGROUND

• Murphy D, Failla JM, Koniuch MP. Steroid versus placebo injection for trigger finger. J Hand Surg Am. 1995 Jul;20(4):628-31. doi: 10.1016/S0363-5023(05)80280-1.

  PMID: 7594291 BACKGROUND

• Newport ML, Lane LB, Stuchin SA. Treatment of trigger finger by steroid injection. J Hand Surg Am. 1990 Sep;15(5):748-50. doi: 10.1016/0363-5023(90)90149-l.

  PMID: 2229972 BACKGROUND

• 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.

  PMID: 6488636 BACKGROUND

• Ring D, Lozano-Calderon 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.

  PMID: 18406955 BACKGROUND

• Stahl S, Kanter Y, Karnielli E. Outcome of trigger finger treatment in diabetes. J Diabetes Complications. 1997 Sep-Oct;11(5):287-90. doi: 10.1016/s1056-8727(96)00076-1.

  PMID: 9334911 BACKGROUND

• Wolfe, Scott W. "Chapter 62-Tendinopathy." Green's Operative Hand Surgery, 6th Ed. Elsevier, Philadelphia. 2011.

  BACKGROUND

MeSH Terms

Conditions

Trigger Finger Disorder

Interventions

Triamcinolone; Triamcinolone Acetonide; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pregnadienetriols; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Dr. Ericka Lawler
• Organization: University of Iowa

ericka-lawler@uiowa.edu

3193563943

Study Officials

• Ericka Lawler, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 22, 2018
• Study Start: January 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 31, 2019
• Results First Posted: May 31, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)