Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jeppe Lange, MD, Regionshospitalet Silkeborg
ClinicalTrials.gov Identifier:
NCT01486420
First received: December 1, 2011
Last updated: March 3, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
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 Regionshospitalet Silkeborg:

Primary Outcome Measures:
  • Quinell grade [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Pain following either procedure measured by NRS (score 0-10, 10 is severe pain)

  • infection [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Infection occurence following either procedure


Estimated Enrollment: 166
Study Start Date: January 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: February 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 and older
Genders Eligible for Study:   Both
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

No publications provided

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: March 3, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by 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 September 30, 2014