Ultrasound Guided Corticosteroid Injection at A1 Pulley in Comparison to Percutaneous A1 Pulley Release as a Treatment for Idiopathic Trigger Finger
Primary Purpose
US-guided Release of the A1 Pulley Responsible for Trigger Finger is Feasible With a 21-gauge Needle
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasonography-guided injection
pullae A1 release
Sponsored by
About this trial
This is an interventional treatment trial for US-guided Release of the A1 Pulley Responsible for Trigger Finger is Feasible With a 21-gauge Needle
Eligibility Criteria
Inclusion Criteria:
- Idiopathic trigger finger present for at least 3 months.
Exclusion Criteria:
- Patients with diabetes mellitus, previous history of open release for trigger finger, different inflammatory arthritis and multiple trigger fingers affections.
Sites / Locations
- Assiut governorate
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
. Group A
Group B
Arm Description
Underwent ultrasound guided methyl prednisolone acetate injection, between A1 pulley and tendons
Underwent ultrasonography-guided percutaneous A1 pulley needle release
Outcomes
Primary Outcome Measures
trigger finger classification grade
trigger finger classification grade
Secondary Outcome Measures
Pain score
visual analogue scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05170152
Brief Title
Ultrasound Guided Corticosteroid Injection at A1 Pulley in Comparison to Percutaneous A1 Pulley Release as a Treatment for Idiopathic Trigger Finger
Official Title
The Efficacy of Ultrasound Guided Corticosteroid Injection at A1 Pulley in Comparison to Percutaneous A1 Pulley Release as a Treatment for Idiopathic Trigger Finger
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objectives: To compare the efficacy of ultrasonography guided corticosteroid injection at A1 pulley and percutaneous A1 pulley release as a treatment for trigger finger.
Methods: 75 patients with idiopathic trigger finger were enrolled in our prospective study. Patients with diabetes mellitus, previous history of open release for trigger finger, different inflammatory arthritis and multiple trigger fingers affections were excluded. Group A 40 patients: Underwent ultrasound guided methyl prednisolone acetate injection, between A1 pulley and tendons .Group B 35 patients :Underwent ultrasonography-guided percutaneous A1 pulley needle release .All patients were subjected to the following before and after intervention by 1 and 3 months , DASH, trigger finger classification grade & VAS
Detailed Description
Trigger finger ( TF) is a pathologic problem of the finger leads to a painful tendon snap or click on flexion and extension, and/or locking of the metacarpophalangealor proximal interphalngeal joint (1) . Entrapment of the affected tendon at the first annular (A1) pulley occurs because of a differencein the diameter of the flexor tendon and its sheath as a result of thickening of the sheath and or localized tendon thickening.(1) . Most cases of trigger fingers are idiopathic and the incidence is around 28 cases per 100 000 population per year, or a lifetime risk of 2.6% in the general population and about 10% of patients are diabetics (1). Women are usually more affected than men, usually in the fifth and sixth decades(2) it is more common in women than in men, usually in the dominant hand, and most often in the thumb or ring fingers followed . (2) The diagnosis of trigger finger is based mainly on the medical history and clinical examination. The most important characteristic clinical sign is the mechanical blocking of the finger when flexed with painful snapping extended. (3). Management includes many options such as conservative treatment in the form of splinting, physical therapy, non-steroidal anti-inflammatory drugs, and local steroid injections, and surgical pulley release
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
US-guided Release of the A1 Pulley Responsible for Trigger Finger is Feasible With a 21-gauge Needle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
. Group A
Arm Type
Active Comparator
Arm Description
Underwent ultrasound guided methyl prednisolone acetate injection, between A1 pulley and tendons
Arm Title
Group B
Arm Type
Experimental
Arm Description
Underwent ultrasonography-guided percutaneous A1 pulley needle release
Intervention Type
Procedure
Intervention Name(s)
ultrasonography-guided injection
Intervention Description
ultrasonography-guided injection
Intervention Type
Procedure
Intervention Name(s)
pullae A1 release
Intervention Description
ultrasonography-guided pullae A1 release
Primary Outcome Measure Information:
Title
trigger finger classification grade
Description
trigger finger classification grade
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pain score
Description
visual analogue scale
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Idiopathic trigger finger present for at least 3 months.
Exclusion Criteria:
Patients with diabetes mellitus, previous history of open release for trigger finger, different inflammatory arthritis and multiple trigger fingers affections.
Facility Information:
Facility Name
Assiut governorate
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
yes after publication
Learn more about this trial
Ultrasound Guided Corticosteroid Injection at A1 Pulley in Comparison to Percutaneous A1 Pulley Release as a Treatment for Idiopathic Trigger Finger
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