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Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger

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ClinicalTrials.gov Identifier: NCT01486420
Recruitment Status : Completed
First Posted : December 6, 2011
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Jeppe Lange, MD, Regionshospitalet Silkeborg

Brief Summary:
The purpose of the study is to investigate which strategy is superior in trigger finger Quinell grade IIb-V; conventional open surgery or ultrasound guided corticosteroid injections.

Condition or disease Intervention/treatment Phase
Trigger Finger Procedure: Corticosteroid injections Procedure: Open surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Surgery Versus Ultrasound Guided Local Corticosteroid Injections in Treatment of Trigger Finger - a Randomized Controlled Trial.
Study Start Date : January 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Active Comparator: Open surgery Procedure: Open surgery
Open A1-pulley release

Active Comparator: Corticosteroid Injection Procedure: Corticosteroid injections
Corticosteroid injections in and around A1-pulley.




Primary Outcome Measures :
  1. Quinell grade [ Time Frame: 12 months ]

    Dicotomized outcome defined as +/- failure. Failure defined as Quinell grade equal to or above IIb.

    Quinell grade defined as: I Normal movement, IIa normal movement with pain/tenderness to A1-pulley, IIb anamnestic triggering but not evident at clinical exam, III triggering without locking, IV triggering with locking but actively correctable, V Locked digit, passive correctable only.



Secondary Outcome Measures :
  1. Numerical Rating Scale (NRS) score [ Time Frame: 12 weeks ]
    Pain following either procedure measured by NRS (score 0-10, 10 is severe pain)

  2. infection [ Time Frame: 12 weeks ]
    Infection occurence following either procedure



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Trigger finger Quinell grade IIb-V in digit I-V

Exclusion Criteria:

  • Former treatment of Trigger finger in affected digit
  • Dupuytrens contracture in affected digit
  • Allergies or intolerance to used medications
  • Rheumatoid Arthritis
  • Insulin dependent Diabetes Mellitus
  • Amyloidosis
  • Mucopolysaccharidosis
  • Already included in study with another digit

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): NCT01486420


Locations
Denmark
Center for Planned surgery - Regionalhospital Silkeborg
Silkeborg, Denmark, 8600
Sponsors and Collaborators
Jeppe Lange, MD
Investigators
Study Director: Jeppe Lange, M.D. Center for Planned Surgery - Regionalhospital Silkeborg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeppe Lange, MD, Senior project superviser, Regionshospitalet Silkeborg
ClinicalTrials.gov Identifier: NCT01486420     History of Changes
Other Study ID Numbers: M-20110157
First Posted: December 6, 2011    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015

Keywords provided by Jeppe Lange, MD, Regionshospitalet Silkeborg:
Quinell grade
Open surgery
corticosteroid injections
randomized controlled trial
Trigger finger

Additional relevant MeSH terms:
Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases