This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeppe Lange, MD, Regionshospitalet Silkeborg
ClinicalTrials.gov Identifier:
NCT01486420
First received: December 1, 2011
Last updated: October 27, 2015
Last verified: October 2015
  Purpose
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 Intervention
Trigger Finger Procedure: Corticosteroid injections Procedure: Open surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Surgery Versus Ultrasound Guided Local Corticosteroid Injections in Treatment of Trigger Finger - a Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Jeppe Lange, MD, Regionshospitalet Silkeborg:

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

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


Enrollment: 166
Study Start Date: January 2012
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: December 1, 2011
Last Updated: October 27, 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
Tenosynovitis
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 21, 2017