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Trial record 3 of 4 for:    "Tenosynovitis" | "Hormone Antagonists"

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

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ClinicalTrials.gov Identifier: NCT04002037
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Sebastien Lalonde, University of Missouri-Columbia

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).

Condition or disease Intervention/treatment Phase
Trigger Finger Drug: Triamcinolone Acetonide 40mg/mL Drug: Triamcinolone Acetonide 10mg/mL Drug: Dexamethasone 4 mg/ml Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis: A Double-Blind Prospective Randomized Clinical Trial
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : June 15, 2025
Estimated Study Completion Date : June 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Active Comparator: Triamcinolone 40mg/mL
A corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger.
Drug: Triamcinolone Acetonide 40mg/mL
Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.

Active Comparator: Triamcinolone 10mg/mL
A corticosteroid injection of Triamcinolone 10mg/mL will be given to subjects to treat their symptoms of trigger finger.
Drug: Triamcinolone Acetonide 10mg/mL
Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.

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.
Drug: Dexamethasone 4 mg/ml
Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Upper Extremity Scores (PROMIS) [ Time Frame: 6 Weeks ]
    The patient will be asked to complete a questionnaire with questions related to their hand.

  11. Upper Extremity Scores (PROMIS) [ Time Frame: 12 Weeks ]
    The patient will be asked to complete a questionnaire with questions related to their hand.

  12. Upper Extremity Scores (PROMIS) [ Time Frame: 6 Month ]
    The patient will be asked to complete a questionnaire with questions related to their hand.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04002037


Contacts
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Contact: Stacee Clawson 573-884-9017 clawsons@health.missouri.edu
Contact: Lauren Livesay livesayl@health.missouri.edu

Locations
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United States, Missouri
University of Missouri Health Care Recruiting
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Sebastian Lalonde, MD University of Missouri-Columbia

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.

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Responsible Party: Sebastien Lalonde, Hand and Microvascular Surgeon, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04002037     History of Changes
Other Study ID Numbers: 2014036
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019

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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
Keywords provided by Sebastien Lalonde, University of Missouri-Columbia:
Trigger Finger
Additional relevant MeSH terms:
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Tenosynovitis
Hormones, Hormone Substitutes, and Hormone Antagonists
Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Dexamethasone
Dexamethasone acetate
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
BB 1101
Triamcinolone diacetate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors