search
Back to results

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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 22, 2021
Last Updated
August 29, 2022
Sponsor
Assiut University
search

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

We'll reach out to this number within 24 hrs