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

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ClinicalTrials.gov Identifier: NCT03641508
Recruitment Status : Completed
First Posted : August 22, 2018
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Ericka Lawler, University of Iowa

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.


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Study Type : Interventional  (Clinical Trial)
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 : January 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016


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 Name: 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 Name: Decadron




Primary Outcome Measures :
  1. Number of Participants With no Symptoms of Trigger Finger [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641508


Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Ericka Lawler
Investigators
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Principal Investigator: Ericka Lawler, MD University of Iowa

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

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Responsible Party: Ericka Lawler, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03641508     History of Changes
Other Study ID Numbers: 201308766
First Posted: August 22, 2018    Key Record Dates
Results First Posted: May 31, 2019
Last Update Posted: May 31, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, University of Iowa:
trigger finger
Additional relevant MeSH terms:
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Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Dexamethasone
Dexamethasone acetate
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Lidocaine
Epinephrine
Racepinephrine
Epinephryl borate
BB 1101
Triamcinolone diacetate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action