Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01486420|
Recruitment Status : Completed
First Posted : December 6, 2011
Last Update Posted : October 28, 2015
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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.
- 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
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
|Center for Planned surgery - Regionalhospital Silkeborg|
|Silkeborg, Denmark, 8600|
|Study Director:||Jeppe Lange, M.D.||Center for Planned Surgery - Regionalhospital Silkeborg|