US-guided Release of the A1 Pulley Responsible for Trigger Finger is Feasible With a 21-gauge NeedleNCT05170152
Ultrasound Guided Corticosteroid Injection at A1 Pulley in Comparison to Percutaneous A1 Pulley Release as a Treatment for Idiopathic Trigger Finger
A study testing ultrasonography-guided injection and pullae A1 release in people with US-guided Release of the A1 Pulley Responsible for Trigger Finger is Feasible With a 21-gauge Needle, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- US-guided Release of the A1 Pulley Responsible for Trigger Finger is Feasible With a 21-gauge Needle
- What is being tested?
- ultrasonography-guided injection and pullae A1 release
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic trigger finger present for at least 3 months.
Who cannot join
- Patients with diabetes mellitus, previous history of open release for trigger finger, different inflammatory arthritis and multiple trigger fingers affections.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- US-guided Release of the A1 Pulley Responsible for Trigger Finger is Feasible With a 21-gauge Needle
- Being tested
- ultrasonography-guided injection, pullae A1 release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonography-guided injectionProcedure or surgery
ultrasonography-guided injection
pullae A1 releaseProcedure or surgery
ultrasonography-guided pullae A1 release
| Study group | Role | What they receive |
|---|---|---|
| . Group A | Active comparator | Underwent ultrasound guided methyl prednisolone acetate injection, between A1 pulley and tendons Receives: Procedure: ultrasonography-guided injection |
| Group B | Experimental | Underwent ultrasonography-guided percutaneous A1 pulley needle release Receives: Procedure: pullae A1 release |
What is being measured
The primary outcome is the main question the study is designed to answer.
trigger finger classification grade
trigger finger classification grade
Measured: 3 months
Secondary outcomes (1)
Pain score
visual analogue scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start1 Nov 2020
- Primary completion1 Feb 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for US-guided Release of the A1 Pulley Responsible for Trigger Finger is Feasible With a 21-gauge NeedleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Hassanien, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170152
- Sponsor's protocol ID
- trigger finger
- Status last verified
- Aug 2022
- First submitted
- 22 Dec 2021
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: yes after publication
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05170152
- Acronym / sponsor ID
- trigger finger
- Conditions
- US-guided Release of the A1 Pulley Responsible for Trigger Finger is Feasible With a 21-gauge Needle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| . Group A | Active comparator | Procedure: ultrasonography-guided injectionUnderwent ultrasound guided methyl prednisolone acetate injection, between A1 pulley and tendons |
| Group B | Experimental | Procedure: pullae A1 releaseUnderwent ultrasonography-guided percutaneous A1 pulley needle release |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Idiopathic trigger finger present for at least 3 months.
Key exclusion criteria (1 listed)
- Patients with diabetes mellitus, previous history of open release for trigger finger, different inflammatory arthritis and multiple trigger fingers affections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonography-guided injectionultrasonography-guided injection | Procedure or surgery | . Group A |
| pullae A1 releaseultrasonography-guided pullae A1 release | Procedure or surgery | Group B |
Primary outcome
trigger finger classification grade
Time frame: 3 months
trigger finger classification grade
1 secondary outcome
Pain score
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Individual participant dataSharing planned: Undecided. yes after publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonography-guided injection and pullae A1 release in people with US-guided Release of the A1 Pulley Responsible for Trigger Finger is Feasible With a 21-gauge Needle, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
trigger finger classification grade (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.