Trigger FingerNCT07364695
Early Postoperative Function After Open Versus Ultrasound-Guided Trigger Finger Release
An observational study of Trigger Finger, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
Clinical outcomes after open trigger finger release are excellent. Minimally invasive techiques with ultrasound guidance theoretically offer advantages for faster recovery but this technique has not been compared prospectively with the standard of care (open trigger release). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigger Finger
- What is being tested?
- UltraGuideTFR (Sonex Health, MN, USA)
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jun 2023to 31 Dec 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing trigger finger release for the index through small fingers was conducted from June 2023 through June 2024 at two tertiary care academic medical centers in an integrated health network
Who may be able to join
- undergoing trigger finger release for the index through small fingers due to symptoms refractory to conservative treatment and elected for surgical intervention through shared decision-making
- English-speaking adults (≥18 years of age)
- Patients with inflammatory arthritis were included if their diagnosis had been established ≥5 years prior without exacerbations in the past 5 years. Those on immunomodulatory therapy were required to have been on a stable regimen for ≥5 years without flare-ups.
Who cannot join
- prior surgery on the affected finger
- corticosteroid injection in the affected hand within 6 weeks
- additional hand or wrist pathology requiring concurrent surgery
- symptomatic trigger finger in the contralateral extremity
- prior surgical pulley release in either hand within 6 months of enrollment
- Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus) not controlled
Show all 14Show fewer
- inflammatory arthritis if diagnosis established <5 years, exacerbation within the past 5 years, or modifications to immunomodulatory therapy within 5 years of enrollment
- Amyloidosis
- Diabetes not controlled by a stable dose of medication over the past three months
- Pregnant or planning pregnancy in the next 6 months
- Workers' compensation subjects
- Inability to provide a legally acceptable Informed Consent Form and/or comply with all follow-up requirements, including patients who do not speak English
- other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
- Trigger Thumb
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02114
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Early Postoperative Function After Open Versus Ultrasound-Guided Trigger Finger Release: A Prospective Comparative Cohort Study
Clinical outcomes after open trigger finger release are excellent. Minimally invasive techiques with ultrasound guidance theoretically offer advantages for faster recovery but this technique has not been compared prospectively with the standard of care (open trigger release). This study aims to prospectively analyze patient-reported outcomes in patients undergoing open vs. ultrasound-guided trigger finger release.
Read the detailed description
Trigger finger is initially treated conservatively. Conservative treatment options include modification of activities, painkiller administration, splinting, and corticosteroid injections (1). Open or minimally invasive surgical treatment can be considered if conservative treatment fails. Minimally invasive surgery options consist of ultrasound-guided or blind percutaneous trigger finger release.
Many studies have reported good clinical outcomes after ultrasound-guided trigger finger release, including low rates of catching or locking recurrence rates, high QuickDASH scores and high patient satisfaction (2-4).
Postoperative clinical outcomes of open surgery have been widely compared to percutaneous surgery (5-8). However, the comparison of postoperative results between ultrasound-guided and open trigger finger release has been scarcely reported. Nikolaou et al. reported that ultrasound-guided trigger finger release resulted in a significantly sooner return to normal activities and better patient-reported cosmetic outcomes than open trigger finger release (9). Success rates and mean QuickDASH scores did not differ significantly between these groups in this cohort.
The potential benefits of ultrasound-guided trigger finger release compared to open trigger finger release have yet to be investigated. This study aims to prospectively analyze patient-reported outcomes in patients undergoing open vs. ultrasound-guided trigger finger release.
- Conditions
- Trigger Finger
- Being tested
- UltraGuideTFR (Sonex Health, MN, USA)
- Keywords
- trigger finger release, ultrasound, open, clinical outcomes, return to work
- 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.
UltraGuideTFR (Sonex Health, MN, USA)Device
SonexHealth percutaneous trigger finger release device used in ultrasound-guided release cohort
| Study group | Role | What they receive |
|---|---|---|
| Open Release | Patients who underwent open trigger finger release | |
| Ultrasound-Guided Release | Patients who underwent ultrasound-guided trigger finger release Receives: Device: UltraGuideTFR (Sonex Health, MN, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities of Daily Living (Study-specific questionnaire)
Study-specific survey of limitations with Activities of Daily Living. Responses for questions on the study-specific survey for limitations with ADLS utilized a Likert scale with 1 representing no difficulty with the task and 5 being unable to perform the task due to limitations from trigger finger symptoms. Likert scale responses for the 12 ADLs on the survey were summated for final scores ranging from 14 (no difficulty with any ADLs) to 70 (unable to perform any ADLs). These were standardized to a 100-point scale to facilitate clinical interpretation of outcomes. A score of 0 represented no functional limitations with ADLs and a score of 100 represented inability to perform any ADL on the survey.
Measured: From enrollment to final follow-up at 6 months
Pain on the Visual Analogue Scale
VAS pain score on a scale from 1 to 10 with a score of 1 representating no pain and score or 10 representing maximal pain.
Measured: From enrollment to final follow-up at 6 months
Secondary outcomes (2)
Timing of Return to work
Timing of return to work in days as reported by patient. Minimum value is 0 days, meaning patient reported returning to work on the day of the procedure. No maximum value applicable.
Measured: From 2 days post-procedure to final follow-up at 6 months
Patient satisfaction with procedure
Patient reported satisfaction with procedure. Response of either yes or no to the following question: Are you satisfied with the procedure, and would you choose to have it again for a similar problem?
Measured: Single evaluation at final follow-up 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start20 Jun 2023
- Primary completion26 Jun 2024
- Study completion31 Dec 2024
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.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rohit Garg, Massachusetts General Hospital
- Investigators
- Rohit Garg, MBBS, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364695
- Sponsor's protocol ID
- 2023P003220
- Status last verified
- Mar 2026
- First submitted
- 11 Dec 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Anonymized patient data can be shared upon reasonable request for transparency
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Function After Open Versus Ultrasound-Guided Trigger Finger Release: A Prospective Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT07364695
- Acronym / sponsor ID
- 2023P003220
- Conditions
- Trigger Finger
- Keywords
- trigger finger release, ultrasound, open, clinical outcomes, return to work
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 23 Jan 2026 (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.
Clinical outcomes after open trigger finger release are excellent. Minimally invasive techiques with ultrasound guidance theoretically offer advantages for faster recovery but this technique has not been compared prospectively with the standard of care (open trigger release). This study aims to prospectively analyze patient-reported outcomes in patients undergoing open vs. ultrasound-guided trigger finger release.
Detailed description
Trigger finger is initially treated conservatively. Conservative treatment options include modification of activities, painkiller administration, splinting, and corticosteroid injections (1). Open or minimally invasive surgical treatment can be considered if conservative treatment fails. Minimally invasive surgery options consist of ultrasound-guided or blind percutaneous trigger finger release.
Many studies have reported good clinical outcomes after ultrasound-guided trigger finger release, including low rates of catching or locking recurrence rates, high QuickDASH scores and high patient satisfaction (2-4).
Postoperative clinical outcomes of open surgery have been widely compared to percutaneous surgery (5-8). However, the comparison of postoperative results between ultrasound-guided and open trigger finger release has been scarcely reported. Nikolaou et al. reported that ultrasound-guided trigger finger release resulted in a significantly sooner return to normal activities and better patient-reported cosmetic outcomes than open trigger finger release (9). Success rates and mean QuickDASH scores did not differ significantly between these groups in this cohort.
The potential benefits of ultrasound-guided trigger finger release compared to open trigger finger release have yet to be investigated. This study aims to prospectively analyze patient-reported outcomes in patients undergoing open vs. ultrasound-guided trigger finger release.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Release | – | –Patients who underwent open trigger finger release |
| Ultrasound-Guided Release | – | Device: UltraGuideTFR (Sonex Health, MN, USA)Patients who underwent ultrasound-guided trigger finger release |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing trigger finger release for the index through small fingers was conducted from June 2023 through June 2024 at two tertiary care academic medical centers in an integrated health network
Key inclusion criteria (3 listed)
- undergoing trigger finger release for the index through small fingers due to symptoms refractory to conservative treatment and elected for surgical intervention through shared decision-making
- English-speaking adults (≥18 years of age)
- Patients with inflammatory arthritis were included if their diagnosis had been established ≥5 years prior without exacerbations in the past 5 years. Those on immunomodulatory therapy were required to have been on a stable regimen for ≥5 years without flare-ups.
Key exclusion criteria (14 listed)
- prior surgery on the affected finger
- corticosteroid injection in the affected hand within 6 weeks
- additional hand or wrist pathology requiring concurrent surgery
- symptomatic trigger finger in the contralateral extremity
- prior surgical pulley release in either hand within 6 months of enrollment
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 |
|---|---|---|
| UltraGuideTFR (Sonex Health, MN, USA)SonexHealth percutaneous trigger finger release device used in ultrasound-guided release cohort | Device | Ultrasound-Guided Release |
Primary outcome
Activities of Daily Living (Study-specific questionnaire)
Time frame: From enrollment to final follow-up at 6 months
Study-specific survey of limitations with Activities of Daily Living. Responses for questions on the study-specific survey for limitations with ADLS utilized a Likert scale with 1 representing no difficulty with the task and 5 being unable to perform the task due to limitations from trigger finger symptoms. Likert scale responses for the 12 ADLs on the survey were summated for final scores ranging from 14 (no difficulty with any ADLs) to 70 (unable to perform any ADLs). These were standardized to a 100-point scale to facilitate clinical interpretation of outcomes. A score of 0 represented no functional limitations with ADLs and a score of 100 represented inability to perform any ADL on the survey.
Pain on the Visual Analogue Scale
Time frame: From enrollment to final follow-up at 6 months
VAS pain score on a scale from 1 to 10 with a score of 1 representating no pain and score or 10 representing maximal pain.
2 secondary outcomes
Timing of Return to work
Time frame: From 2 days post-procedure to final follow-up at 6 months
Patient satisfaction with procedure
Time frame: Single evaluation at final follow-up 6 months post-procedure
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 25 Mar 2026.
- Individual participant dataSharing planned: Yes. Anonymized patient data can be shared upon reasonable request for transparency
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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.
Rohit Garg, MBBS principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigger Finger, run by Massachusetts General Hospital at 2 sites in United States.
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 14 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 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Activities of Daily Living (Study-specific questionnaire) (time frame: From enrollment to final follow-up at 6 months). The study lists 2 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 25 Mar 2026.