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出境医 / 临床实验 / Long Term Effectiveness of Trigger Finger Injections With Triamcinolone vs. Dexamethasone

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

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
Layout table for study information
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
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 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
Outcome Measures
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.



Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Ericka Lawler
Investigators
Layout table for investigator information
Principal Investigator: Ericka Lawler, MD University of Iowa
Tracking Information
First Submitted Date  ICMJE August 4, 2017
First Posted Date  ICMJE August 22, 2018
Results First Submitted Date  ICMJE September 19, 2018
Results First Posted Date  ICMJE May 31, 2019
Last Update Posted Date May 31, 2019
Actual Study Start Date  ICMJE January 2014
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2018)
  • Time to onset [ Time Frame: 6 weeks ]
    Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble) vs. dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble).
  • Time to onset [ Time Frame: 6 months ]
    Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble) vs. dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble).
  • Time to onset [ Time Frame: 1 year ]
    Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble) vs. dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble).
  • Time to onset [ Time Frame: 2 years ]
    Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble) vs. dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble).
  • Duration of response [ Time Frame: 6 weeks ]
    Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble) vs. dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble).
  • Duration of response [ Time Frame: 6 months ]
    Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble) vs. dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble).
  • Duration of response [ Time Frame: 1 year ]
    Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble) vs. dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble).
  • Duration of response [ Time Frame: 2 years ]
    Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble) vs. dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Effectiveness of Trigger Finger Injections With Triamcinolone vs. Dexamethasone
Official Title  ICMJE Long Term Effectiveness of Trigger Finger Injections With Triamcinolone vs. Dexamethasone
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Trigger Finger Disorder
Intervention  ICMJE
  • Drug: Triamcinolone
    Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble). This will be mixed with 1% lidocaine without epinephrine
    Other Name: Kenalog
  • Drug: Dexamethasone
    dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble). Again, this will be mixed with 1% lidocaine without epinephrine
    Other Name: Decadron
Study Arms  ICMJE
  • Active Comparator: Triamcinolone
    The study drug used will be triamcinolone mixed with 1% lidocaine without epinephrine
    Intervention: Drug: Triamcinolone
  • Active Comparator: Dexamethasone
    The study drug used will be dexamethasone mixed with 1% lidocaine without epinephrine
    Intervention: Drug: Dexamethasone
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2019) 		69
Original Actual Enrollment  ICMJE
 (submitted: August 17, 2018) 		85
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03641508
Other Study ID Numbers  ICMJE 201308766
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ericka Lawler, University of Iowa
Study Sponsor  ICMJE Ericka Lawler
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ericka Lawler, MD University of Iowa
PRS Account University of Iowa
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP