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

December 1, 2011
October 27, 2015
January 2012
October 2015   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01486420 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger
Open Surgery Versus Ultrasound Guided Local Corticosteroid Injections in Treatment of Trigger Finger - a Randomized Controlled Trial.
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Trigger Finger
  • Procedure: Corticosteroid injections
    Corticosteroid injections in and around A1-pulley.
  • Procedure: Open surgery
    Open A1-pulley release
  • Active Comparator: Open surgery
    Intervention: Procedure: Open surgery
  • Active Comparator: Corticosteroid Injection
    Intervention: Procedure: Corticosteroid injections
Hansen RL, Lange J. Surgery versus ultrasound-guided steroid injections for trigger finger disease: protocol of a randomized controlled trial. Dan Med J. 2013 May;60(5):A4633.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
166
October 2015
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01486420
M-20110157
No
Not Provided
Not Provided
Jeppe Lange, MD, Regionshospitalet Silkeborg
Jeppe Lange, MD
Not Provided
Study Director: Jeppe Lange, M.D. Center for Planned Surgery - Regionalhospital Silkeborg
Regionshospitalet Silkeborg
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP