Functional Disturbance as ResultNCT06267105
A Clinical Study to Compare Functional Outcomes After Surgery Using a Transverse or Longitudinal Surgical Incision in the Skin.
A study testing Longitudinal incision and Transverse incision in people with Functional Disturbance as Result, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Trigger finger is a common pathology in the hand. Patients suffer from pain and depending on which tasks, patients have difficulty to perform them. Its treatment in initial and less serious phases includes conservative measures, but failure of these may require releasing the trigger finger with surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Functional Disturbance as Result
- What is being tested?
- Longitudinal incision and Transverse incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2024to Mar 2028
- 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 over 18 years of age.
- Clinical diagnosis of trigger finger grade II to IV.
- Grade I (pre-trigger) Pain, history of entrapment, but not demonstrable on physical examination, tenderness over the A1 pulley.
- Grade II (active) Demonstrable entrapment, but the patient can actively extend the finger.
- Grade III (passive) Demonstrable entrapment, patient requires passive extension IIIA or inability to actively flex IIIB.
- Grade IV (contracture) Demonstrable entrapment with fixed flexion contracture of the PIP.
Who cannot join
- Thumb
- Polydigital
- Allergy to local anesthetics and/or vasoconstrictor agents.
- Previous surgery
- Patients who, in the researcher's opinion, are not good candidates for the study (e.g. inability to comply with the follow-up program, comorbidity, poor physical or mental health in general, drug or alcohol abuse problems...).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Parc taulí
Sabadell, Barcelona, 08208
Mireia
About this study
Official title: Clinical Study to Compare Functional Results in Patients Affected by Trigger Finger When Surgery is Performed Through a Transverse or Longitudinal Surgical Incision in the Skin.
Trigger finger is a common pathology in the hand. Patients suffer from pain and depending on which tasks, patients have difficulty to perform them. Its treatment in initial and less serious phases includes conservative measures, but failure of these may require releasing the trigger finger with surgery. The surgical technique performed for trigger finger is the opening of the A1 pulley, the skin incisions used for this surgery are various (transverse, longitudinal, oblique). Trigger finger surgery presents good results in terms of resolution, but complications may also occur. The reason for this study is to assess whether there are functional differences using the Dash scale when we perform a transverse or longitudinal incision in trigger finger surgery.
- Conditions
- Functional Disturbance as Result
- Being tested
- Longitudinal incision, Transverse incision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longitudinal incisionProcedure or surgery
Incision performed longitudinally
Transverse incisionProcedure or surgery
Incision performed transversally
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal incision | Experimental | Incision performed longitudinally Receives: Procedure: Longitudinal incision |
| Transverse incision | Experimental | Incision performed transversally Receives: Procedure: Transverse incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional improvement of the patient after surgery
functional improvement of the patient after surgery, which will be assessed with the Dash scale, 1 being difficult while 5 being unable
Measured: Immediately after surgery
Secondary outcomes (10)
Surgeon comfort
Ecellent, good, poor
Measured: Immediately after surgery
Resolution
Presence or absence of engagment
Measured: 1, 3 and 6 months
Flushed
Red or not red
Measured: 1, 3 and 6 months
Pain feeling
EVA scale from 0 to 10, being 10 a lot of pain
Measured: 1, 3 and 6 months
Contracture
Range of motion in degrees
Measured: 1, 3 and 6 months
Infection
Septic signs such the area is red, hot, swelling or has drain pus
Measured: 1, 3 and 6 months
Nerve injury
Allen test to evaluate correct circulation, the hand should turn white when pressing
Measured: 1, 3 and 6 months
Return to work
How many weeks after surgery
Measured: 1, 3 and 6 months
Reincorporation to activities
How many weeks after surgery
Measured: 1, 3 and 6 months
Sensitivity Test
In a scale from 0 to 10
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 May 2024
- Primary completionOct 2027 (estimated)
- Study completionMar 2028 (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 Functional Disturbance as ResultStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corona Poy, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267105
- Sponsor's protocol ID
- A1-LORT
- Status last verified
- Oct 2026
- First submitted
- 31 Jan 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohd Rashid MZ, Sapuan J, Abdullah S. A randomized controlled trial of trigger finger release under digital anesthesia with (WALANT) and without adrenaline. J Orthop Surg (Hong Kong). 2019 Jan-Apr;27(1):2309499019833002. doi: 10.1177/2309499019833002.
PubMed 30852960Kazmers NH, Holt D, Tyser AR, Wang A, Hutchinson DT. A prospective, randomized clinical trial of transverse versus longitudinal incisions for trigger finger release. J Hand Surg Eur Vol. 2019 Oct;44(8):810-815. doi: 10.1177/1753193419859375. Epub 2019 Jul 4.
PubMed 31272265Kloeters O, Ulrich DJ, Bloemsma G, van Houdt CI. Comparison of three different incision techniques in A1 pulley release on scar tissue formation and postoperative rehabilitation. Arch Orthop Trauma Surg. 2016 May;136(5):731-7. doi: 10.1007/s00402-016-2430-z. Epub 2016 Feb 29.
PubMed 26926477
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Compare Functional Results in Patients Affected by Trigger Finger When Surgery is Performed Through a Transverse or Longitudinal Surgical Incision in the Skin.
- ClinicalTrials.gov ID
- NCT06267105
- Acronym / sponsor ID
- A1-LORT
- Conditions
- Functional Disturbance as Result
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 20 Feb 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 pathology in the hand. Patients suffer from pain and depending on which tasks, patients have difficulty to perform them. Its treatment in initial and less serious phases includes conservative measures, but failure of these may require releasing the trigger finger with surgery. The surgical technique performed for trigger finger is the opening of the A1 pulley, the skin incisions used for this surgery are various (transverse, longitudinal, oblique). Trigger finger surgery presents good results in terms of resolution, but complications may also occur. The reason for this study is to assess whether there are functional differences using the Dash scale when we perform a transverse or longitudinal incision in trigger finger surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Longitudinal incision | Experimental | Procedure: Longitudinal incisionIncision performed longitudinally |
| Transverse incision | Experimental | Procedure: Transverse incisionIncision performed transversally |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients over 18 years of age.
- Clinical diagnosis of trigger finger grade II to IV.
- Grade I (pre-trigger) Pain, history of entrapment, but not demonstrable on physical examination, tenderness over the A1 pulley.
- Grade II (active) Demonstrable entrapment, but the patient can actively extend the finger.
- Grade III (passive) Demonstrable entrapment, patient requires passive extension IIIA or inability to actively flex IIIB.
Key exclusion criteria (5 listed)
- Thumb
- Polydigital
- Allergy to local anesthetics and/or vasoconstrictor agents.
- Previous surgery
- Patients who, in the researcher's opinion, are not good candidates for the study (e.g. inability to comply with the follow-up program, comorbidity, poor physical or mental health in general, drug or alcohol abuse problems...).
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 |
|---|---|---|
| Longitudinal incisionIncision performed longitudinally | Procedure or surgery | Longitudinal incision |
| Transverse incisionIncision performed transversally | Procedure or surgery | Transverse incision |
Primary outcome
Functional improvement of the patient after surgery
Time frame: Immediately after surgery
functional improvement of the patient after surgery, which will be assessed with the Dash scale, 1 being difficult while 5 being unable
10 secondary outcomes
Surgeon comfort
Time frame: Immediately after surgery
Resolution
Time frame: 1, 3 and 6 months
Flushed
Time frame: 1, 3 and 6 months
Pain feeling
Time frame: 1, 3 and 6 months
Contracture
Time frame: 1, 3 and 6 months
Infection
Time frame: 1, 3 and 6 months
Nerve injury
Time frame: 1, 3 and 6 months
Return to work
Time frame: 1, 3 and 6 months
Reincorporation to activities
Time frame: 1, 3 and 6 months
Sensitivity Test
Time frame: 1, 3 and 6 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 21 Oct 2026.
- Background: PubMed 30852960Mohd Rashid MZ, Sapuan J, Abdullah S. A randomized controlled trial of trigger finger release under digital anesthesia with (WALANT) and without adrenaline. J Orthop Surg (Hong Kong). 2019 Jan-Apr;27(1):2309499019833002. doi: 10.1177/2309499019833002.
- Background: PubMed 31272265Kazmers NH, Holt D, Tyser AR, Wang A, Hutchinson DT. A prospective, randomized clinical trial of transverse versus longitudinal incisions for trigger finger release. J Hand Surg Eur Vol. 2019 Oct;44(8):810-815. doi: 10.1177/1753193419859375. Epub 2019 Jul 4.
- Background: PubMed 26926477Kloeters O, Ulrich DJ, Bloemsma G, van Houdt CI. Comparison of three different incision techniques in A1 pulley release on scar tissue formation and postoperative rehabilitation. Arch Orthop Trauma Surg. 2016 May;136(5):731-7. doi: 10.1007/s00402-016-2430-z. Epub 2016 Feb 29.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Longitudinal incision and Transverse incision in people with Functional Disturbance as Result, run by Corporacion Parc Tauli at 1 site in Spain.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. 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 Spain. 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?
Contact Mireia Vinas (+34 93 723 10 10 ext. 21652, mmvinas@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional improvement of the patient after surgery (time frame: Immediately after surgery). 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 NCT06267105, 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 21 Oct 2026.