Back to resultsOpen Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger
Primary Purpose
Trigger Finger
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Corticosteroid injections
Open surgery
Sponsored by
About this trial
This is an interventional treatment trial for Trigger Finger focused on measuring Quinell grade, Open surgery, corticosteroid injections, randomized controlled trial, Trigger finger
Eligibility 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
Sites / Locations
- Center for Planned surgery - Regionalhospital Silkeborg
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Open surgery
Corticosteroid Injection
Arm Description
Outcomes
Primary Outcome Measures
Quinell grade
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
Pain following either procedure measured by NRS (score 0-10, 10 is severe pain)
infection
Infection occurence following either procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01486420
Brief Title
Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger
Official Title
Open Surgery Versus Ultrasound Guided Local Corticosteroid Injections in Treatment of Trigger Finger - a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeppe Lange, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger
Keywords
Quinell grade, Open surgery, corticosteroid injections, randomized controlled trial, Trigger finger
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open surgery
Arm Type
Active Comparator
Arm Title
Corticosteroid Injection
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Corticosteroid injections
Intervention Description
Corticosteroid injections in and around A1-pulley.
Intervention Type
Procedure
Intervention Name(s)
Open surgery
Intervention Description
Open A1-pulley release
Primary Outcome Measure Information:
Title
Quinell grade
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Numerical Rating Scale (NRS) score
Description
Pain following either procedure measured by NRS (score 0-10, 10 is severe pain)
Time Frame
12 weeks
Title
infection
Description
Infection occurence following either procedure
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeppe Lange, M.D.
Organizational Affiliation
Center for Planned Surgery - Regionalhospital Silkeborg
Official's Role
Study Director
Facility Information:
Facility Name
Center for Planned surgery - Regionalhospital Silkeborg
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
23673265
Citation
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.
Results Reference
derived
Learn more about this trial
Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger
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