Trigger FingerNCT06785935
Comparison Between 2 Treatment Modalities of Trigger Finger: Ultrasound-guided Percutaneous Release of A1 Pulley by a Needle Knife Versus Ultrasound-guided Corticosteroid Injection in the Treatment of Trigger Finger
A study testing Needle knife and Corticosteroid: Betamethasone in people with Trigger Finger, run by Mansoura University Hospital at 1 site in Egypt.
Trial summary
Trigger finger is a common cause of hand disability and pain in the general population. It is a pathologic condition of the digital pulleys and flexor tendons. Although the pathogenesis is incompletely clear and multifactorial, the most common cause of the trigger finger is the thickened flexor tendon and/or thickened… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trigger Finger
- What is being tested?
- Needle knife and Corticosteroid: Betamethasone
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Idiopathic trigger finger
- Trigger finger at the level of A1 pulley
- Trigger finger of Green's grades II or III
Who cannot join
- Patients with secondary causes of trigger fingers like diabetes mellitus, rheumatoid arthritis, gout, hypothyroidism, amyloidosis, and sarcoidosis.
- Patients with a previous history of first annular pulley release or injection.
- Patients with trigger fingers of Green's grade I and IV.
- Patients with trigger fingers at any level other than the A1 pulley.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Percutaneous Release of A1 Pulley by a Needle Knife Versus Ultrasound-guided Corticosteroid Injection in the Treatment of Trigger Finger: a Randomized Clinical Trial
Trigger finger is a common cause of hand disability and pain in the general population. It is a pathologic condition of the digital pulleys and flexor tendons. Although the pathogenesis is incompletely clear and multifactorial, the most common cause of the trigger finger is the thickened flexor tendon and/or thickened first annular (A1) pulley located at the metacarpophalangeal joint. Currently, ultrasound is considered an effective and valuable tool for assessing the trigger finger, providing static and dynamic evaluations of this condition and a comparison with the adjacent normal digits. Recently, it has been reported that ultrasound-guided percutaneous A1 pulley precise release using a needle knife has received increasing attention in the clinical treatment of trigger fingers and achieved good results. To our knowledge, this is the first clinical study comparing the efficacy and safety of ultrasonic-guided percutaneous A1 pulley release with a needle knife and the ultrasonic-guided steroid injection in treating trigger fingers.
- Conditions
- Trigger Finger
- Being tested
- Needle knife, Corticosteroid: Betamethasone
- Medical subject headings
- Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle knifeDevice
ultrasonography-guided percutaneous A1 pulley release using a needle knife
Corticosteroid: BetamethasoneDrug
ultrasonography-guided corticosteroid injection under the A1 pulley
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing ultrasonography-guided percutaneous A1 pulley release using a needle knife | Active comparator | Not described Receives: Device: Needle knife |
| Patients undergoing ultrasonography-guided corticosteroid injection under the A1 pulley | Active comparator | Not described Receives: Drug: Corticosteroid: Betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity using the visual analog scale (VAS) scoring system
Measured: Before the procedure as well as after one week, one month, and three months
Functional ability according to the standard quick disabilities of the arm, shoulder, and hand score (Q DASH) questionnaire
Measured: Before the procedure as well as after one week, one month, and three months
Recurrence: The grade of trigger finger according to Green's classification
Measured: Before the procedure as well as after one week, one month, and three months
Complications such as inflammation, infection, scarring, wound healing problems, and sensory changes
Measured: After one week of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start11 Nov 2024
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger FingerStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran Khalid Ibrahim Sallam, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785935
- Sponsor's protocol ID
- MS.24.10.2929
- Status last verified
- Dec 2024
- First submitted
- 15 Jan 2025
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Percutaneous Release of A1 Pulley by a Needle Knife Versus Ultrasound-guided Corticosteroid Injection in the Treatment of Trigger Finger: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06785935
- Acronym / sponsor ID
- MS.24.10.2929
- Conditions
- Trigger Finger
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Jan 2025 (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.
Trigger finger is a common cause of hand disability and pain in the general population. It is a pathologic condition of the digital pulleys and flexor tendons. Although the pathogenesis is incompletely clear and multifactorial, the most common cause of the trigger finger is the thickened flexor tendon and/or thickened first annular (A1) pulley located at the metacarpophalangeal joint. Currently, ultrasound is considered an effective and valuable tool for assessing the trigger finger, providing static and dynamic evaluations of this condition and a comparison with the adjacent normal digits. Recently, it has been reported that ultrasound-guided percutaneous A1 pulley precise release using a needle knife has received increasing attention in the clinical treatment of trigger fingers and achieved good results. To our knowledge, this is the first clinical study comparing the efficacy and safety of ultrasonic-guided percutaneous A1 pulley release with a needle knife and the ultrasonic-guided steroid injection in treating trigger fingers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing ultrasonography-guided percutaneous A1 pulley release using a needle knife | Active comparator | Device: Needle knife |
| Patients undergoing ultrasonography-guided corticosteroid injection under the A1 pulley | Active comparator | Drug: Corticosteroid: Betamethasone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic trigger finger
- Trigger finger at the level of A1 pulley
- Trigger finger of Green's grades II or III
Key exclusion criteria (4 listed)
- Patients with secondary causes of trigger fingers like diabetes mellitus, rheumatoid arthritis, gout, hypothyroidism, amyloidosis, and sarcoidosis.
- Patients with a previous history of first annular pulley release or injection.
- Patients with trigger fingers of Green's grade I and IV.
- Patients with trigger fingers at any level other than the A1 pulley.
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 |
|---|---|---|
| Needle knifeultrasonography-guided percutaneous A1 pulley release using a needle knife | Device | Patients undergoing ultrasonography-guided percutaneous A1 pulley release using a needle knife |
| Corticosteroid: Betamethasoneultrasonography-guided corticosteroid injection under the A1 pulley | Drug | Patients undergoing ultrasonography-guided corticosteroid injection under the A1 pulley |
Primary outcome
Pain intensity using the visual analog scale (VAS) scoring system
Time frame: Before the procedure as well as after one week, one month, and three months
Functional ability according to the standard quick disabilities of the arm, shoulder, and hand score (Q DASH) questionnaire
Time frame: Before the procedure as well as after one week, one month, and three months
Recurrence: The grade of trigger finger according to Green's classification
Time frame: Before the procedure as well as after one week, one month, and three months
Complications such as inflammation, infection, scarring, wound healing problems, and sensory changes
Time frame: After one week of the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2025.
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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 Needle knife and Corticosteroid: Betamethasone in people with Trigger Finger, run by Mansoura University Hospital 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pain intensity using the visual analog scale (VAS) scoring system (time frame: Before the procedure as well as after one week, one month, and three months). The study lists 4 primary outcomes in all. 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 21 Jan 2025.