Trigger FingerNCT01781130
Effect of Steroid Injection Which is Added to Percutaneous Trigger Finger Release: a Double-blinded Randomized Controlled Trial.
A study testing Steroid injection in people with Trigger Finger, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Background Present treatment strategies for trigger finger when conservative management including steroid injection was failed include percutaneous or open A1 pulley release, but some people showed prolonged swelling and delay of complete healing. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Trigger Finger
- What is being tested?
- Steroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Jun 2014
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trigger finger patients who require surgical intervention due to failuer of sufficient time of conservative treatment
Who cannot join
- Age under 18 years old
- Rheumatoid arthritis patients
- Patients who got steroid injection more than 4 times previously
- Multiple finger affected at presentation
- Previous surgery history
- Any recent trauma history of affected hand
Trial locations and contacts
1 site in 1 country.
About this study
Background
Present treatment strategies for trigger finger when conservative management including steroid injection was failed include percutaneous or open A1 pulley release, but some people showed prolonged swelling and delay of complete healing.
Read more
We aimed to test the hypothesis that an improved outcome can be achieved by employing steroid injection simultaneously with percutaneous release compared with conventional percutaneous release alone
Methods
We designed a double-blind, randomized controlled trial.
Inclusion criteria is the patient who has symptom of trigger finger warranted surgical release after sufficient time of conservative treatment.
Exclusion criteria are as follow: 1) multiple fingers at presentation; 2) Rheumatoid arthritis patients; 3) Pregnant or lactating patients; 4) Younger than 18 years old; 5) Previous surgery history of finger 6); the patients who got steroid injection more than 4 time previously; 7) coagulation abnormality including usage of anti-thrombotic agent.
After power analysis by a statistician, total 40 patients would be required for each group (percutaneous alone group versus percutaneous alone + steroid injection group).
The surgery will be performed by outpatients clinic basis with local injection. Additional steroid injection will be given to half of patients after allocation with randomized selection by permutaed block randomization.
Primary outcome measure is mean fall in pain visual analogue scale (pVAS) and secondary outcome will be proportion of patients with good response (defined as "Perfect" or "much better" as reported by patients).
Follow-up will be conducted 3 weeks and 3 month after index procedure
- Conditions
- Trigger Finger
- Being tested
- Steroid injection
- 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.
Steroid injectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous release alone | Placebo comparator | The patients who perform percutaneous release of trigger finger only |
| Percutaneous release + Steroid injection | Experimental | Steroid local injection after percutaneous release of trigger finger Receives: Procedure: Steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain VAS
Measured: 3 month after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trigger FingerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Jong Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781130
- Sponsor's protocol ID
- 2012-11-112-002
- Status last verified
- May 2015
- First submitted
- 15 Jan 2013
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Patel MR, Moradia VJ. Percutaneous release of trigger digit with and without cortisone injection. J Hand Surg Am. 1997 Jan;22(1):150-5. doi: 10.1016/S0363-5023(05)80196-0.
PubMed 9018629
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Steroid Injection Which is Added to Percutaneous Trigger Finger Release: a Double-blinded Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01781130
- Acronym / sponsor ID
- 2012-11-112-002
- Conditions
- Trigger Finger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 31 Jan 2013 (estimated)
- 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
Present treatment strategies for trigger finger when conservative management including steroid injection was failed include percutaneous or open A1 pulley release, but some people showed prolonged swelling and delay of complete healing.
We aimed to test the hypothesis that an improved outcome can be achieved by employing steroid injection simultaneously with percutaneous release compared with conventional percutaneous release alone
Methods
We designed a double-blind, randomized controlled trial.
Inclusion criteria is the patient who has symptom of trigger finger warranted surgical release after sufficient time of conservative treatment.
Exclusion criteria are as follow: 1) multiple fingers at presentation; 2) Rheumatoid arthritis patients; 3) Pregnant or lactating patients; 4) Younger than 18 years old; 5) Previous surgery history of finger 6); the patients who got steroid injection more than 4 time previously; 7) coagulation abnormality including usage of anti-thrombotic agent.
After power analysis by a statistician, total 40 patients would be required for each group (percutaneous alone group versus percutaneous alone + steroid injection group).
The surgery will be performed by outpatients clinic basis with local injection. Additional steroid injection will be given to half of patients after allocation with randomized selection by permutaed block randomization.
Primary outcome measure is mean fall in pain visual analogue scale (pVAS) and secondary outcome will be proportion of patients with good response (defined as "Perfect" or "much better" as reported by patients).
Follow-up will be conducted 3 weeks and 3 month after index procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous release alone | Placebo comparator | –The patients who perform percutaneous release of trigger finger only |
| Percutaneous release + Steroid injection | Experimental | Procedure: Steroid injectionSteroid local injection after percutaneous release of trigger finger |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Trigger finger patients who require surgical intervention due to failuer of sufficient time of conservative treatment
Key exclusion criteria (6 listed)
- Age under 18 years old
- Rheumatoid arthritis patients
- Patients who got steroid injection more than 4 times previously
- Multiple finger affected at presentation
- Previous surgery history
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 |
|---|---|---|
| Steroid injection | Procedure or surgery | Percutaneous release + Steroid injection |
Primary outcome
pain VAS
Time frame: 3 month after 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 18 May 2015.
- Background: PubMed 9018629Patel MR, Moradia VJ. Percutaneous release of trigger digit with and without cortisone injection. J Hand Surg Am. 1997 Jan;22(1):150-5. doi: 10.1016/S0363-5023(05)80196-0.
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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 Steroid injection in people with Trigger Finger, run by Samsung Medical Center at 1 site in South Korea.
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 1 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 18 May 2015. 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 South Korea. 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?
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?
pain VAS (time frame: 3 month after procedure). 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 NCT01781130, which also lists 1 linked publication.
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 18 May 2015.