Trigger FingerPhase 3NCT06288685
Percutaneous Trigger Finger Release Concomitant Steroid Injection Versus Percutaneous Trigger Finger Release Alone
A Phase 3 study testing percutaneous A1 pulley release and Triamcinolone in people with Trigger Finger and Percutaneous A1 Pulley Release, run by Police General Hospital, Thailand at 1 site in Thailand.
Trial summary
Background: Percutaneous A1 pulley release is a cost-effective and straightforward procedure with outcomes comparable to open A1 pulley release. Postoperative pain is a prevalent concern. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigger Finger, Percutaneous A1 Pulley Release, Steroid Injection
- What is being tested?
- percutaneous A1 pulley release and Triamcinolone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteThailand
- Study dates
- 11 Oct 2023to 30 Jan 2024
- Phase
- Phase 3
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinical diagnosis of trigger finger
- aged 18 years or older
- trigger finger are classified under Quinell's grade 2, 3, or 4
Who cannot join
- a history of prior hand surgery
- Dupuytren's disease
- type 1 diabetes
- previous phalangeal fractures
- recent steroid injection within the last month
- autoimmune diseases
Trial locations and contacts
1 site in 1 country.
About this study
Background:
Percutaneous A1 pulley release is a cost-effective and straightforward procedure with outcomes comparable to open A1 pulley release. Postoperative pain is a prevalent concern. Corticosteroid injection is a common nonoperative treatment for trigger finger, providing favorable outcomes but associated with a notable risk of recurrence. Numerous studies have explored the combined approach of percutaneous trigger finger release with corticosteroid injection. However, to date, there is no report on early postoperative results.
Read more
Objective:
To conduct a comparative analysis of early postoperative outcomes between percutaneous A1 pulley release with steroid injection and percutaneous A1 pulley release alone.
Study Design \& Methods:
This study constitutes a randomized controlled trial involving patients with trigger finger who underwent percutaneous release surgery from October 2023 to January 2024. A total of 38 patients were enrolled, with 18 assigned to the percutaneous A1 pulley release with steroid injection group and 20 to the percutaneous A1 pulley release alone group. Postoperative assessments included pain scores using the Visual Analog Scale (VAS), evaluation of quality of life through the QuickDASH score (qDASH), patient satisfaction, and complications.
Read the detailed description
Material and Methods
Study Population:
Patients diagnosed with trigger finger, aged 18 years or older, and classified under Quinell's grade 2, 3, or 4, were included in the study [ ]. Recruitment took place at the Outpatient Orthopedic Department of the Police General Hospital between October 2023 and January 2024. Exclusion criteria encompassed individuals with a history of prior hand surgery, Dupuytren's disease, type 1 diabetes, previous phalangeal fractures, recent steroid injection within the last month, and autoimmune diseases.
Group allocation and Randomization:
Patients were enrolled and randomized into two groups, percutaneous A1 pulley release with steroid injection (Group A) and percutaneous A1 pulley release alone (Group B), by utilizing computer generate randomization and the results were put in opaque sealed envelopes. Informed consent was obtained from all participants, and surgeries were performed by the same surgeon (WJ).
Surgical Technique:
The surgical procedure followed Eastwood's method [ ], involving the following steps:
- Preparation of the sterile field.
- Injection of 1% lidocaine with epinephrine at the surgical site.
- Insertion of an 18-gauge needle following the tract from the previous injection.
- Patient extension of the finger to bring flexor tendons close to the skin, moving the neurovascular structures away.
- Slow penetration of the needle until it is over the A1 pulley.
- Gentle flexion of the finger while observing the needle tip to prevent penetrating the flexor tendon.
- Rotation of the needle bevel into a longitudinal orientation to the flexor tendon.
- Release of the A1 pulley by moving the needle upward and downward parallel to the flexor tendon until complete release is achieved.
- Withdrawal of the needle while hyperextending the finger.
- Flexion and extension of the finger to check for triggering.
- Injection of triamcinolone (40mg/ml) 1 ml in the study group.
- Closure of the wound with a small elastic dressing.
Postoperative Protocols:
Both groups received identical postoperative protocols, including the same medications (Augmentin, Naproxen, Tolperisone) for 7 days. Patients were encouraged for early finger range of motion without restriction.
Outcome Measures:
The primary outcome measure was pain score assessed by the VAS. Secondary outcomes included quality of life measured by the qDASH score, patient satisfaction, and surgical complications.
Follow-Up:
All cases underwent follow-up via telephone on postoperative days 1 to 6, in the clinic during the first and second weeks, and at 1 to 2 months postoperative.
Statistical analysis In this study, all data calculations were conducted using Stata software (version 17.0). Group comparisons involved the application of Pearson's chi-squared test or Continuity Correction chi-squared test for categorical variables, and the student's t-test was employed for continuous variables. Statistically significant differences were defined as those with a P-value < 0.05.
- Being tested
- percutaneous A1 pulley release, Triamcinolone
- Medical subject headings
- Trigger Finger Disorder, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous A1 pulley releaseProcedure or surgery
Treatment trigger finger by release A1 pulley by percutaneous procedure
TriamcinoloneDrug
Triamcinolone 40mg/ml 1 ml injection concomitant percutaneous A1 pulley release
| Study group | Role | What they receive |
|---|---|---|
| group1 | Experimental | percutaneous A1 pulley release with Triamcinolone injection Receives: Procedure: percutaneous A1 pulley release; Drug: Triamcinolone |
| group0 | Active comparator | percutaneous A1 pulley release alone Receives: Procedure: percutaneous A1 pulley release |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain score
VAS(visual analog scale) from 0 to 10, 0 mean there is no pain, 10 there is the most pain in participants life
Measured: post operative Day0 until 2 months
Secondary outcomes (2)
hand function by quickDASH
quickDASH(questionnaire in Thai version), score from 0-100, 0 mean there is no limitation of daily hand activity, 100 mean participants got disability in that upper limb
Measured: post operative Day0 until 2 months
patients satisfaction
1 is lowest satisfaction, 5 is most satisfaction
Measured: post operative Day0 until 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start11 Oct 2023
- Primary completion23 Jan 2024
- Study completion30 Jan 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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients diagnosed with trigger finger, aged 18 years or older, and classified under Quinell's grade 2, 3, or 4, were included in the study \[ \]. Recruitment took place at the Outpatient Orthopedic Department of the Police General Hospital between October 2023 and January 2024. Exclusion criteria encompassed individuals with a history of prior hand surgery, Dupuytren's disease, type 1 diabetes, previous phalangeal fractures, recent steroid injection within the last month, and autoimmune diseases.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Police General Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weeraphat Saartying, Police General Hospital, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288685
- Sponsor's protocol ID
- 73/256
- Other IDs
- 73/256
- Status last verified
- Mar 2024
- First submitted
- 17 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing the Dermographic data of the participants including age, BMI, Occupation and sharing of pain score, quality of life and satisfaction in result table
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Trigger Finger Release Concomitant Steroid Injection Versus Percutaneous Trigger Finger Release Alone
- ClinicalTrials.gov ID
- NCT06288685
- Acronym / sponsor ID
- 73/256
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Police General Hospital, ThailandUniversity, hospital or other
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 1 Mar 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.
Background:
Percutaneous A1 pulley release is a cost-effective and straightforward procedure with outcomes comparable to open A1 pulley release. Postoperative pain is a prevalent concern. Corticosteroid injection is a common nonoperative treatment for trigger finger, providing favorable outcomes but associated with a notable risk of recurrence. Numerous studies have explored the combined approach of percutaneous trigger finger release with corticosteroid injection. However, to date, there is no report on early postoperative results.
Objective:
To conduct a comparative analysis of early postoperative outcomes between percutaneous A1 pulley release with steroid injection and percutaneous A1 pulley release alone.
Study Design \& Methods:
This study constitutes a randomized controlled trial involving patients with trigger finger who underwent percutaneous release surgery from October 2023 to January 2024. A total of 38 patients were enrolled, with 18 assigned to the percutaneous A1 pulley release with steroid injection group and 20 to the percutaneous A1 pulley release alone group. Postoperative assessments included pain scores using the Visual Analog Scale (VAS), evaluation of quality of life through the QuickDASH score (qDASH), patient satisfaction, and complications.
Detailed description
Material and Methods
Study Population:
Patients diagnosed with trigger finger, aged 18 years or older, and classified under Quinell's grade 2, 3, or 4, were included in the study [ ]. Recruitment took place at the Outpatient Orthopedic Department of the Police General Hospital between October 2023 and January 2024. Exclusion criteria encompassed individuals with a history of prior hand surgery, Dupuytren's disease, type 1 diabetes, previous phalangeal fractures, recent steroid injection within the last month, and autoimmune diseases.
Group allocation and Randomization:
Patients were enrolled and randomized into two groups, percutaneous A1 pulley release with steroid injection (Group A) and percutaneous A1 pulley release alone (Group B), by utilizing computer generate randomization and the results were put in opaque sealed envelopes. Informed consent was obtained from all participants, and surgeries were performed by the same surgeon (WJ).
Surgical Technique:
The surgical procedure followed Eastwood's method [ ], involving the following steps:
- Preparation of the sterile field.
- Injection of 1% lidocaine with epinephrine at the surgical site.
- Insertion of an 18-gauge needle following the tract from the previous injection.
- Patient extension of the finger to bring flexor tendons close to the skin, moving the neurovascular structures away.
- Slow penetration of the needle until it is over the A1 pulley.
- Gentle flexion of the finger while observing the needle tip to prevent penetrating the flexor tendon.
- Rotation of the needle bevel into a longitudinal orientation to the flexor tendon.
- Release of the A1 pulley by moving the needle upward and downward parallel to the flexor tendon until complete release is achieved.
- Withdrawal of the needle while hyperextending the finger.
- Flexion and extension of the finger to check for triggering.
- Injection of triamcinolone (40mg/ml) 1 ml in the study group.
- Closure of the wound with a small elastic dressing.
Postoperative Protocols:
Both groups received identical postoperative protocols, including the same medications (Augmentin, Naproxen, Tolperisone) for 7 days. Patients were encouraged for early finger range of motion without restriction.
Outcome Measures:
The primary outcome measure was pain score assessed by the VAS. Secondary outcomes included quality of life measured by the qDASH score, patient satisfaction, and surgical complications.
Follow-Up:
All cases underwent follow-up via telephone on postoperative days 1 to 6, in the clinic during the first and second weeks, and at 1 to 2 months postoperative.
Statistical analysis In this study, all data calculations were conducted using Stata software (version 17.0). Group comparisons involved the application of Pearson's chi-squared test or Continuity Correction chi-squared test for categorical variables, and the student's t-test was employed for continuous variables. Statistically significant differences were defined as those with a P-value < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients diagnosed with trigger finger, aged 18 years or older, and classified under Quinell's grade 2, 3, or 4, were included in the study [ ]. Recruitment took place at the Outpatient Orthopedic Department of the Police General Hospital between October 2023 and January 2024. Exclusion criteria encompassed individuals with a history of prior hand surgery, Dupuytren's disease, type 1 diabetes, previous phalangeal fractures, recent steroid injection within the last month, and autoimmune diseases.
| Arm | Type | Receives |
|---|---|---|
| group1 | Experimental | Procedure: percutaneous A1 pulley release, Drug: Triamcinolonepercutaneous A1 pulley release with Triamcinolone injection |
| group0 | Active comparator | Procedure: percutaneous A1 pulley releasepercutaneous A1 pulley release alone |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of trigger finger
- aged 18 years or older
- trigger finger are classified under Quinell's grade 2, 3, or 4
Key exclusion criteria (6 listed)
- a history of prior hand surgery
- Dupuytren's disease
- type 1 diabetes
- previous phalangeal fractures
- recent steroid injection within the last month
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 |
|---|---|---|
| percutaneous A1 pulley releaseTreatment trigger finger by release A1 pulley by percutaneous procedure | Procedure or surgery | group0, group1 |
| TriamcinoloneTriamcinolone 40mg/ml 1 ml injection concomitant percutaneous A1 pulley release | Drug | group1 |
Primary outcome
postoperative pain score
Time frame: post operative Day0 until 2 months
VAS(visual analog scale) from 0 to 10, 0 mean there is no pain, 10 there is the most pain in participants life
2 secondary outcomes
hand function by quickDASH
Time frame: post operative Day0 until 2 months
patients satisfaction
Time frame: post operative Day0 until 2 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 12 Mar 2024.
- Individual participant dataSharing planned: Yes. Sharing the Dermographic data of the participants including age, BMI, Occupation and sharing of pain score, quality of life and satisfaction in result table
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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 Phase 3 study testing percutaneous A1 pulley release and Triamcinolone in people with Trigger Finger and Percutaneous A1 Pulley Release, run by Police General Hospital, Thailand at 1 site in Thailand.
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 6 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 12 Mar 2024. 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 Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
postoperative pain score (time frame: post operative Day0 until 2 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 12 Mar 2024.