Trigger DigitNCT06747962
Pull-out Tenolysis Versus Simple A1 Pulley Release in Trigger Digits
A study testing A1 pulley release and pull out tenolysis and Simple A1 pulley release in people with Trigger Digit, run by Eleni Karagergou at 1 site in Greece.
Trial summary
Trigger finger is a common tendinopathy and clinically presents with painful catching or popping as the patient flexes and extends the digit, due to mechanical impingement of the thickened flexor tendons as they pass through a narrow tendon sheath canal at the level of the metacarpal head. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Trigger Digit
- What is being tested?
- A1 pulley release and pull out tenolysis and Simple A1 pulley release
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2025to Jan 2027
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with single trigger finger that failed conservative treatment
- Patients with single trigger finger that had recurrence of symptoms after conservative treatment
Who cannot join
- Patients with limited range of movement before appearance of triggering
- Patients with osteoarthritis / rheumatoid arthritis
- Patients that had a second procedure at the same time of trigger finger release (eg carpal tunnel release).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dimitrios Kitridis, MD contact
Greece1 site
Aristotle University of Thessaloniki, 1st Orthopaedic Department, G. Papanikolaou Hospital
Thessaloniki, Thessaloniki, 57010
Panagiotis Givissis, Professor, Head of Orthopaedic, +302313307681, orthopaedikipapanikolaou@gmail.com
Panagiotis Givissis, Professor
About this study
Official title: A1 Pulley Release and Pull-out Tenolysis Versus Simple A1 Pulley Release in Trigger Fingers and Thumb. a Randomized Controlled Trial
Trigger finger is a common tendinopathy and clinically presents with painful catching or popping as the patient flexes and extends the digit, due to mechanical impingement of the thickened flexor tendons as they pass through a narrow tendon sheath canal at the level of the metacarpal head. If conservative management with corticosteroid injection and splinting fails or if symptoms recur, surgery and division of the A1 pulley are indicated. Traction (or pull- out) tenolysis is a maneuver based on pulling of the flexor tendons out of the wound, to release any adhesions that might have occurred due to long- standing triggering. Although it has been associated with postoperative pain and stiffness, no robust evidence exists to support its benefit or not. In view of the low quality evidence regarding the pros and cons of traction (or pull-out) tenolysis following A1 pulley release, the investigators will compare simple A1 pulley release versus A1 pulley release and pull-out tenolysis in a prospective randomized study design. Hypothesis of the study is that the pull- out tenolysis yields better results in terms of total active range of movement, pinch and grip strength, pain and quick-DASH scoring when compared to simple pulley release. The confirmation of the hypothesis will justify the use of pull-out tenolysis as a means of breaking any tendon adhesions and returning to normal function sooner. On the contrary, if the pull-out tenolysis is linked to a less favorable functional outcome, simple A1 pulley release will be recommended.
Read the detailed description
Trigger finger is a common condition that can cause hand pain and disability. It involves entrapment of the flexor tendons of the fingers and thumb within their flexor tendon sheath at the level of the metacarpal head. This phenomenon is due to the mechanical impingement of the thickened flexor tendons as they pass through a narrow tendon sheath canal. It can cause painful catching or popping as the patient flexes and extends the digit. On occasion, the digit will lock in flexion and require passive manipulation to extend. Initial management can be conservative with corticosteroid injection and splinting. If conservative management fails or if symptoms recur, surgical release of the A1 pulley is indicated. This is a common procedure which is performed under local anaesthesia. Intraoperatively, following division of A1 pulley, a traction tenolysis is occasionally performed by some surgeons. This maneuver, which is based on pulling of the flexor tendons out of the wound, is believed to release any adhesions that might have occurred due to long- standing triggering but it has been reported to result in prolonged postoperative pain and stiffness. However, there is no robust evidence to support a less favorable outcome following traction tenolysis. Aim of the study: In view of the low quality evidence regarding the pros and cons of traction (or pull-out) tenolysis following A1 pulley release, the investigators will compare simple A1 pulley release versus A1 pulley release and pull-out tenolysis in a prospective randomized study design. Hypothesis of the study is that the pull-out tenolysis yields better results in terms of total active range of movement, pinch and grip strength, pain and quick-DASH scoring when compared to simple pulley release. The confirmation of the hypothesis will justify the use of pull-out tenolysis as a means of breaking any tendon adhesions and returning to normal function sooner. On the contrary, if the pull- out tenolysis is linked to a less favorable functional outcome, simple A1 pulley release will be recommended. The study will be conducted in accordance with the Declaration of Helsinki and the Guidelines on Good Clinical Practice.
- Conditions
- Trigger Digit
- Being tested
- A1 pulley release and pull out tenolysis, Simple A1 pulley release
- Keywords
- trigger finger, trigger thumb, traction tenolysis, pull-out tenolysis, A1 pulley
- 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.
A1 pulley release and pull out tenolysisProcedure or surgery
A short transverse incision will be made over the proximal or distal palmar crease, according to the digit involved. Blunt dissection will be used to spread the subcutaneous tissue and the palmar fascia to expose the A1 pulley. The digital nerves and vessels will be retracted and protected. The proximal edge of the A1 pulley will be identified and a scalpel blade will be used to divide the entire A1 pulley under direct vision. Flexor digitorum superficialis and flexor digitorum profundus tendons or flexor pollicis longus tendon (for the thumb) will be gently pulled out of the wound with two mosquito forceps to break any adhesions. The wound will be closed primarily with sutures. The patient will be asked to actively move the digit to confirm complete relief of triggering.The wound will be closed primarily with sutures.
Simple A1 pulley releaseProcedure or surgery
A short transverse incision will be made over the proximal or distal palmar crease, according to the digit involved. Blunt dissection will be used to spread the subcutaneous tissue and the palmar fascia to expose the A1 pulley. The digital nerves and vessels will be retracted and protected. The proximal edge of the A1 pulley will be identified and a scalpel blade will be used to divide the entire A1 pulley vision. After release, the patient will be asked to actively move the digit to confirm complete relief of triggering.The wound will be closed primarily with sutures.
| Study group | Role | What they receive |
|---|---|---|
| Pull out tenolysis group | Active comparator | A1 pulley release and pull out tenolysis for the treatment of trigger fingers and thumb Receives: Procedure: A1 pulley release and pull out tenolysis |
| Simple A1 pulley release group | Placebo comparator | Simple A1 pulley release for the treatment of trigger fingers and thumb Receives: Procedure: Simple A1 pulley release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total active range of motion (AROM) of the affected finger
Comparison of total (AROM) between the groups. Measurements will be done with a goniometer
Measured: 2 weeks
Total active range of motion (AROM) of the affected finger
Comparison of total (AROM) between the groups. Measurements will be done with a goniometer.
Measured: 6 weeks
Total active range of motion (AROM) of the affected finger
Comparison of total (AROM) between the groups. Measurements will be done with a goniometer.
Measured: 3 months
Visual Analog Scale (VAS) for pain relief
Comparison of the VAS for pain between the groups. Minimum 0, Maximum 10, higher scores mean a worse outcome
Measured: 2 weeks
Visual Analog Scale (VAS) for pain relief
Comparison of the VAS for pain between the groups. Minimum 0, Maximum 10, higher scores mean a worse outcome
Measured: 6 weeks
Visual Analog Scale (VAS) for pain relief
Comparison of the VAS for pain between the groups. Minimum 0, Maximum 10, higher scores mean a worse outcome
Measured: 3 months
Secondary outcomes (4)
Grip and Pinch strength
Comparison of grip and pinch strength between the groups, as measured by a dynamometer
Measured: 6 weeks
Grip and Pinch strength
Comparison of grip and pinch strength between the groups, as measured by a dynamometer
Measured: 3 months
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) functional score
Comparison of the QuickDASH score between the two groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.
Measured: 6 weeks
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) functional score
Comparison of the QuickDASH score between the two groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.
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 posted24 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Trigger DigitStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eleni Karagergou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eleni Karagergou, Aristotle University Of Thessaloniki
- Investigators
- Panagiotis Givissis, Professor, Study chair, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747962
- Sponsor's protocol ID
- 1543/ 18.11.2024
- Status last verified
- Jan 2025
- First submitted
- 19 Dec 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choudhury MM, Tay SC. Outcome of traction tenolysis in open trigger finger release--a retrospective review. Hand Surg. 2013;18(3):375-9. doi: 10.1142/S0218810413500421.
PubMed 24156581Baek JH, Chung DW, Lee JH. Factors Causing Prolonged Postoperative Symptoms Despite Absence of Complications After A1 Pulley Release for Trigger Finger. J Hand Surg Am. 2019 Apr;44(4):338.e1-338.e6. doi: 10.1016/j.jhsa.2018.06.023. Epub 2018 Jul 25.
PubMed 30054030Yang TC, Fufa D, Huang HK, Huang YC, Chang MC, Wang JP. Percutaneous A1 Pulley Release Combined with Finger Splint for Trigger Finger with Proximal Interphalangeal Joint Flexion Contracture. J Hand Surg Asian Pac Vol. 2019 Sep;24(3):270-275. doi: 10.1142/S2424835519500334.
PubMed 31438789
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A1 Pulley Release and Pull-out Tenolysis Versus Simple A1 Pulley Release in Trigger Fingers and Thumb. a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06747962
- Acronym / sponsor ID
- 1543/ 18.11.2024
- Conditions
- Trigger Digit
- Keywords
- trigger finger, trigger thumb, traction tenolysis, pull-out tenolysis, A1 pulley
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eleni KaragergouUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 Dec 2024 (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 tendinopathy and clinically presents with painful catching or popping as the patient flexes and extends the digit, due to mechanical impingement of the thickened flexor tendons as they pass through a narrow tendon sheath canal at the level of the metacarpal head. If conservative management with corticosteroid injection and splinting fails or if symptoms recur, surgery and division of the A1 pulley are indicated. Traction (or pull- out) tenolysis is a maneuver based on pulling of the flexor tendons out of the wound, to release any adhesions that might have occurred due to long- standing triggering. Although it has been associated with postoperative pain and stiffness, no robust evidence exists to support its benefit or not. In view of the low quality evidence regarding the pros and cons of traction (or pull-out) tenolysis following A1 pulley release, the investigators will compare simple A1 pulley release versus A1 pulley release and pull-out tenolysis in a prospective randomized study design. Hypothesis of the study is that the pull- out tenolysis yields better results in terms of total active range of movement, pinch and grip strength, pain and quick-DASH scoring when compared to simple pulley release. The confirmation of the hypothesis will justify the use of pull-out tenolysis as a means of breaking any tendon adhesions and returning to normal function sooner. On the contrary, if the pull-out tenolysis is linked to a less favorable functional outcome, simple A1 pulley release will be recommended.
Detailed description
Trigger finger is a common condition that can cause hand pain and disability. It involves entrapment of the flexor tendons of the fingers and thumb within their flexor tendon sheath at the level of the metacarpal head. This phenomenon is due to the mechanical impingement of the thickened flexor tendons as they pass through a narrow tendon sheath canal. It can cause painful catching or popping as the patient flexes and extends the digit. On occasion, the digit will lock in flexion and require passive manipulation to extend. Initial management can be conservative with corticosteroid injection and splinting. If conservative management fails or if symptoms recur, surgical release of the A1 pulley is indicated. This is a common procedure which is performed under local anaesthesia. Intraoperatively, following division of A1 pulley, a traction tenolysis is occasionally performed by some surgeons. This maneuver, which is based on pulling of the flexor tendons out of the wound, is believed to release any adhesions that might have occurred due to long- standing triggering but it has been reported to result in prolonged postoperative pain and stiffness. However, there is no robust evidence to support a less favorable outcome following traction tenolysis. Aim of the study: In view of the low quality evidence regarding the pros and cons of traction (or pull-out) tenolysis following A1 pulley release, the investigators will compare simple A1 pulley release versus A1 pulley release and pull-out tenolysis in a prospective randomized study design. Hypothesis of the study is that the pull-out tenolysis yields better results in terms of total active range of movement, pinch and grip strength, pain and quick-DASH scoring when compared to simple pulley release. The confirmation of the hypothesis will justify the use of pull-out tenolysis as a means of breaking any tendon adhesions and returning to normal function sooner. On the contrary, if the pull- out tenolysis is linked to a less favorable functional outcome, simple A1 pulley release will be recommended. The study will be conducted in accordance with the Declaration of Helsinki and the Guidelines on Good Clinical Practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pull out tenolysis group | Active comparator | Procedure: A1 pulley release and pull out tenolysisA1 pulley release and pull out tenolysis for the treatment of trigger fingers and thumb |
| Simple A1 pulley release group | Placebo comparator | Procedure: Simple A1 pulley releaseSimple A1 pulley release for the treatment of trigger fingers and thumb |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with single trigger finger that failed conservative treatment
- Patients with single trigger finger that had recurrence of symptoms after conservative treatment
Key exclusion criteria (3 listed)
- Patients with limited range of movement before appearance of triggering
- Patients with osteoarthritis / rheumatoid arthritis
- Patients that had a second procedure at the same time of trigger finger release (eg carpal tunnel release).
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 |
|---|---|---|
| A1 pulley release and pull out tenolysisA short transverse incision will be made over the proximal or distal palmar crease, according to the digit involved. Blunt dissection will be used to spread the subcutaneous tissue and the palmar fascia to expose the A1 pulley. The digital nerves and vessels will be retracted and protected. The proximal edge of the A1 pulley will be identified and a scalpel blade will be used to divide the entire A1 pulley under direct vision. Flexor digitorum superficialis and flexor digitorum profundus tendons or flexor pollicis longus tendon (for the thumb) will be gently pulled out of the wound with two mosquito forceps to break any adhesions. The wound will be closed primarily with sutures. The patient will be asked to actively move the digit to confirm complete relief of triggering.The wound will be closed primarily with sutures. | Procedure or surgery | Pull out tenolysis group |
| Simple A1 pulley releaseA short transverse incision will be made over the proximal or distal palmar crease, according to the digit involved. Blunt dissection will be used to spread the subcutaneous tissue and the palmar fascia to expose the A1 pulley. The digital nerves and vessels will be retracted and protected. The proximal edge of the A1 pulley will be identified and a scalpel blade will be used to divide the entire A1 pulley vision. After release, the patient will be asked to actively move the digit to confirm complete relief of triggering.The wound will be closed primarily with sutures. | Procedure or surgery | Simple A1 pulley release group |
Primary outcome
Total active range of motion (AROM) of the affected finger
Time frame: 2 weeks
Comparison of total (AROM) between the groups. Measurements will be done with a goniometer
Total active range of motion (AROM) of the affected finger
Time frame: 6 weeks
Comparison of total (AROM) between the groups. Measurements will be done with a goniometer.
Total active range of motion (AROM) of the affected finger
Time frame: 3 months
Comparison of total (AROM) between the groups. Measurements will be done with a goniometer.
Visual Analog Scale (VAS) for pain relief
Time frame: 2 weeks
Comparison of the VAS for pain between the groups. Minimum 0, Maximum 10, higher scores mean a worse outcome
Visual Analog Scale (VAS) for pain relief
Time frame: 6 weeks
Comparison of the VAS for pain between the groups. Minimum 0, Maximum 10, higher scores mean a worse outcome
Visual Analog Scale (VAS) for pain relief
Time frame: 3 months
Comparison of the VAS for pain between the groups. Minimum 0, Maximum 10, higher scores mean a worse outcome
4 secondary outcomes
Grip and Pinch strength
Time frame: 6 weeks
Grip and Pinch strength
Time frame: 3 months
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) functional score
Time frame: 6 weeks
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) functional score
Time frame: 3 months
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 14 Jan 2025.
- Background: PubMed 24156581Choudhury MM, Tay SC. Outcome of traction tenolysis in open trigger finger release--a retrospective review. Hand Surg. 2013;18(3):375-9. doi: 10.1142/S0218810413500421.
- Background: PubMed 30054030Baek JH, Chung DW, Lee JH. Factors Causing Prolonged Postoperative Symptoms Despite Absence of Complications After A1 Pulley Release for Trigger Finger. J Hand Surg Am. 2019 Apr;44(4):338.e1-338.e6. doi: 10.1016/j.jhsa.2018.06.023. Epub 2018 Jul 25.
- Background: PubMed 31438789Yang TC, Fufa D, Huang HK, Huang YC, Chang MC, Wang JP. Percutaneous A1 Pulley Release Combined with Finger Splint for Trigger Finger with Proximal Interphalangeal Joint Flexion Contracture. J Hand Surg Asian Pac Vol. 2019 Sep;24(3):270-275. doi: 10.1142/S2424835519500334.
- Individual participant dataSharing planned: No
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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.
Dimitrios Kitridis, MD contact
Panagiotis Givissis, Professor study chair
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A1 pulley release and pull out tenolysis and Simple A1 pulley release in people with Trigger Digit, run by Eleni Karagergou at 1 site in Greece.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 14 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 Greece. 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. Some participants in this study may receive a placebo. 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?
Contact Eleni Karagergou, MD, PhD (+306972386716, krgeleni@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total active range of motion (AROM) of the affected finger (time frame: 2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06747962, which also lists 3 linked publications.
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 14 Jan 2025; AzTrials last refreshed its copy on 27 Oct 2026.