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
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 April 23, 2014