Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04002037
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Sebastien Lalonde, University of Missouri-Columbia

Tracking Information
First Submitted Date  ICMJE June 21, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date October 30, 2020
Actual Study Start Date  ICMJE June 25, 2019
Estimated Primary Completion Date June 15, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2019)
  • Green classification of trigger finger severity [ Time Frame: 6 Weeks ]
    The degree of triggering will be determined by the investigator and recorded. The grade of triggering will be scored on a grading scale of 1, 2, 3 or 4. Grade 1 is palm pain and tenderness at A-1 pulley, Grade 2 is catching of digit, and Grade 3 is locking of digit, passively correctable, and Grade 4 is classified as a fixed or locked digit.
  • Green classification of trigger finger severity [ Time Frame: 6 Month ]
    The degree of triggering will be determined by the investigator and recorded. The grade of triggering will be scored on a grading scale of 1, 2, 3 or 4. Grade 1 is palm pain and tenderness at A-1 pulley, Grade 2 is catching of digit, and Grade 3 is locking of digit, passively correctable, and Grade 4 is classified as a fixed or locked digit.
  • Green classification of trigger finger severity [ Time Frame: 12 Weeks ]
    The degree of triggering will be determined by the investigator and recorded. The grade of triggering will be scored on a grading scale of 1, 2, 3 or 4. Grade 1 is palm pain and tenderness at A-1 pulley, Grade 2 is catching of digit, and Grade 3 is locking of digit, passively correctable, and Grade 4 is classified as a fixed or locked digit.
  • Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: 6 Weeks ]
    The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.
  • Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: 12 Weeks ]
    The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.
  • Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: 6 Month ]
    The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.
  • Pain Visual Analog Score (VAS) [ Time Frame: 6 Weeks ]
    The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
  • Pain Visual Analog Score (VAS) [ Time Frame: 12 Weeks ]
    The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
  • Pain Visual Analog Score (VAS) [ Time Frame: 6 Month ]
    The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
  • Upper Extremity Scores (PROMIS) [ Time Frame: 6 Weeks ]
    The patient will be asked to complete a questionnaire with questions related to their hand.
  • Upper Extremity Scores (PROMIS) [ Time Frame: 12 Weeks ]
    The patient will be asked to complete a questionnaire with questions related to their hand.
  • Upper Extremity Scores (PROMIS) [ Time Frame: 6 Month ]
    The patient will be asked to complete a questionnaire with questions related to their hand.
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Green classification of trigger finger severity [ Time Frame: 6 Weeks ]
    The degree of triggering will be determined by the investigator and recorded.
  • Green classification of trigger finger severity [ Time Frame: 6 Month ]
    The degree of triggering will be determined by the investigator and recorded.
  • Green classification of trigger finger severity [ Time Frame: 12 Weeks ]
    The degree of triggering will be determined by the investigator and recorded.
  • Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: 6 Weeks ]
    The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.
  • Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: 12 Weeks ]
    The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.
  • Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: 6 Month ]
    The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.
  • Pain Visual Analog Score (VAS) [ Time Frame: 6 Weeks ]
    The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
  • Pain Visual Analog Score (VAS) [ Time Frame: 12 Weeks ]
    The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
  • Pain Visual Analog Score (VAS) [ Time Frame: 6 Month ]
    The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
  • Upper Extremity Scores (PROMIS) [ Time Frame: 6 Weeks ]
    The patient will be asked to complete a questionnaire with questions related to their hand.
  • Upper Extremity Scores (PROMIS) [ Time Frame: 12 Weeks ]
    The patient will be asked to complete a questionnaire with questions related to their hand.
  • Upper Extremity Scores (PROMIS) [ Time Frame: 6 Month ]
    The patient will be asked to complete a questionnaire with questions related to their hand.
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 Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis
Official Title  ICMJE Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis: A Double-Blind Prospective Randomized Clinical Trial
Brief Summary Trigger finger is a common cause of hand pain and dysfunction. Its due to chronic inflammation of the flexor tendon that leads to a pulley system mismatch. Historically it has been managed either conservatively with corticosteroid injections or through a surgical release of the A1 pulley. Several corticosteroids have been used for injection- dexamethasone, methylprednisolone, triamcinolone, betamethasone, paramethasone, etc. The purpose of out study is to determine if a 0.5 cc injection of Triamcinolone 40 mg/mL will be the most effective steroid injection for the non-surgical treatment. Approximately 200 subjects will be enrolled and randomized to one of three treatment arms: Triamcinolone 40mg/mL, Triamcinolone 10mg/mL and Soluble dexamethasone 4mg/mL. Treatment success will be defined as lack of conversion to surgical treatment, or no desire to proceed with surgery during study period (3 months).
Detailed Description

Idiopathic stenosing tenosynovitis of the digits, more commonly known as "trigger finger", is a common cause of hand pain and dysfunction. Many previous studies have described the pathophysiology of this condition and it can be summarized as inflammation of the flexor tendons leading to a size mismatch between the tendon and the flexor pulley system. By far the most common location of this mismatch is at the A1 pulley.

The current mainstay of treatment has been:

  1. Injection of corticosteroid into the area immediately surrounding the A1 pulley and flexor tendon
  2. Surgical release of the A1 pulley

Several corticosteroids have been used for injection- dexamethasone, methylprednisolone, triamcinolone, betamethasone, paramethasone, etc. Less commonly used treatment strategies have included: topical NSAIDs and extracorporeal shock therapy. The typical progression of treatment is one or two steroid injections and then surgical release if injections have failed.

To our knowledge, there have been no head to head comparison studies of the efficacy of different corticosteroid formulations in preventing conversion to surgical treatment. In our study, the investigators will look at the efficacy of two of the most commonly used steroids: triamcinolone and dexamethasone.

Objectives:

Primary outcome: Treatment success, defined as lack of conversion to surgical treatment, or no desire to proceed with surgery during study period (3 months).

Secondary outcomes: Grade of triggering (Green classification of trigger finger severity1), DASH (Disabilities of the Arm, Shoulder and Hand) and PROMIS Upper Extremity scores, VAS.

Inclusion/Exclusion:

Inclusion criteria:

  1. Adults aged 18 years and older
  2. At least one symptomatic trigger finger
  3. Patients recommended to receive corticosteroid injections

Exclusion criteria:

  1. Previous surgeries/injections for trigger fingers in digit being treated for study
  2. Participating in another clinical trial
  3. Inability to receive corticosteroid injections (i.e. allergies, adverse reactions, etc.)
  4. Unable to sign informed consent
  5. Pregnant or plan to become pregnant

Study Procedures/Methods:

Enrollment/Randomization/Treatment Visit:

Eligible patients presenting with primary flexor tenosynovitis will be enrolled on a voluntary basis. Prior to the injection, subjects will be asked to complete the PROMIS and DASH surveys to collect data at baseline.

Enrolled patients will be randomized to one of three treatment arms:

  1. Triamcinolone 40mg/mL
  2. Triamcinolone 10mg/mL
  3. Soluble dexamethasone 4mg/mL

Each study patient will receive the appropriate corticosteroid injection in the affected digit(s), consisting of a 1:1 mixture of 1% lidocaine plain and corticosteroid, total volume 1cc.

Blinding:

Syringes will be prepared and masked with opaque tape by the clinic nurses, thus providing blinding for providers administering the injection.

Follow-Up/Clinic Visits:

Subjects will be re-evaluated at 6 weeks post-injection and, if still symptomatic, will undergo a second injection of the same corticosteroid solution. At final follow-up (12 weeks), symptomatic patients who have failed treatment after 2 injections will be offered surgical release of the A1 pulley. Subjects who refuse a second injection at 6 weeks follow-up will be offered surgery, and the reason for refusal (treatment failure) will be recorded.

The visits and all research activity will be outlined below:

6 Week Follow-Up:

Objective Measures:

- Grade of triggering (Green classification of trigger finger severity1)

Subjective Measures:

  • DASH
  • PROMIS scores
  • VAS Second Corticosteroid injection (if subject still symptomatic)

    12 Week (3 Month) Follow-Up (if applicable):

Objective Measures:

- Grade of triggering (Green classification of trigger finger severity1)

Subjective Measures:

- DASH

- PROMIS scores

- VAS

6 Month Follow-Up: The patient will be contacted to check on the status of their condition. If they are still experiencing a degree of triggering they will be advised by their physician to return to clinic for a standard of care visit. If they are no longer experiencing triggering, they will be asked to complete a survey over the phone or online only.

Specimen Collection: If a patient is recommended to undergo surgery at the end of the study, the tenosynovium that is normally resected and discarded after surgery will be collected for analysis. After collection these tissues and data will be identified from the patient and assigned a number for use in study analysis. The investigators seek to only collect tissues from patients that are normally removed and discarded during trigger finger release procedures. None of the patients will undergo additional surgical procedures for the collection of tissues in this study. For simplification purposes, potential subjects must agree to the collection of these specimens to participate in the study, even if they do not end up needing surgical intervention.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Trigger Finger
Intervention  ICMJE
  • Drug: Triamcinolone Acetonide 40mg/mL
    Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
  • Drug: Triamcinolone Acetonide 10mg/mL
    Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
  • Drug: Dexamethasone 4 mg/ml
    Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
Study Arms  ICMJE
  • Active Comparator: Triamcinolone 40mg/mL
    A corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger.
    Intervention: Drug: Triamcinolone Acetonide 40mg/mL
  • Active Comparator: Triamcinolone 10mg/mL
    A corticosteroid injection of Triamcinolone 10mg/mL will be given to subjects to treat their symptoms of trigger finger.
    Intervention: Drug: Triamcinolone Acetonide 10mg/mL
  • Active Comparator: Soluble dexamethasone 4mg/mL
    A corticosteroid injection of Soluble Dexamethasone 4mg/mL will be given to subjects to treat their symptoms of trigger finger.
    Intervention: Drug: Dexamethasone 4 mg/ml
Publications * 1- Wolfe SW, Hotchkiss RN, Pederson WC, Kozin SH, Tendinopathy, in: Green's Operative Hand Surgery, 6th edition, Churchill Livingstone, Chap. 62, p. 5, 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 15, 2025
Estimated Primary Completion Date June 15, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adults aged 18 years and older
  2. At least one symptomatic trigger finger
  3. Patients recommended to receive corticosteroid injections

Exclusion Criteria:

  1. Previous surgeries/injections for trigger fingers in digit being treated for study
  2. Participating in another clinical trial
  3. Inability to receive corticosteroid injections (i.e. allergies, adverse reactions, etc.)
  4. Unable to sign informed consent
  5. Pregnant or plan to become pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stacee Clawson 573-884-9017 clawsons@health.missouri.edu
Contact: Lauren Livesay livesayl@health.missouri.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04002037
Other Study ID Numbers  ICMJE 2014036
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sebastien Lalonde, University of Missouri-Columbia
Study Sponsor  ICMJE University of Missouri-Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sebastian Lalonde, MD University of Missouri-Columbia
PRS Account University of Missouri-Columbia
Verification Date October 2020

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