Trigger FingerNCT01486420
Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger
A study testing Corticosteroid injections and Open surgery in people with Trigger Finger, run by Jeppe Lange, MD at 1 site in Denmark.
Trial summary
The purpose of the study is to investigate which strategy is superior in trigger finger Quinell grade IIb-V; conventional open surgery or ultrasound guided corticosteroid injections. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Trigger Finger
- What is being tested?
- Corticosteroid injections and Open surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Oct 2015
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Trigger finger Quinell grade IIb-V in digit I-V
Who cannot join
- Former treatment of Trigger finger in affected digit
- Dupuytrens contracture in affected digit
- Allergies or intolerance to used medications
- Rheumatoid Arthritis
- Insulin dependent Diabetes Mellitus
- Amyloidosis
- Mucopolysaccharidosis
- Already included in study with another digit
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Planned surgery - Regionalhospital Silkeborg
Silkeborg, 8600
About this study
Official title: Open Surgery Versus Ultrasound Guided Local Corticosteroid Injections in Treatment of Trigger Finger - a Randomized Controlled Trial.
The purpose of the study is to investigate which strategy is superior in trigger finger Quinell grade IIb-V; conventional open surgery or ultrasound guided corticosteroid injections.
- Conditions
- Trigger Finger
- Being tested
- Corticosteroid injections, Open surgery
- Keywords
- Quinell grade, Open surgery, corticosteroid injections, randomized controlled trial, Trigger finger
- 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.
Corticosteroid injectionsProcedure or surgery
Corticosteroid injections in and around A1-pulley.
Open surgeryProcedure or surgery
Open A1-pulley release
| Study group | Role | What they receive |
|---|---|---|
| Open surgery | Active comparator | Not described Receives: Procedure: Open surgery |
| Corticosteroid Injection | Active comparator | Not described Receives: Procedure: Corticosteroid injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quinell grade
Dicotomized outcome defined as +/- failure. Failure defined as Quinell grade equal to or above IIb.
Quinell grade defined as: I Normal movement, IIa normal movement with pain/tenderness to A1-pulley, IIb anamnestic triggering but not evident at clinical exam, III triggering without locking, IV triggering with locking but actively correctable, V Locked digit, passive correctable only.
Measured: 12 months
Secondary outcomes (2)
Numerical Rating Scale (NRS) score
Pain following either procedure measured by NRS (score 0-10, 10 is severe pain)
Measured: 12 weeks
infection
Infection occurence following either procedure
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionOct 2015
- Study completionOct 2015
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.
- 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
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeppe Lange, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeppe Lange, MD, Regionshospitalet Silkeborg
- Investigators
- Jeppe Lange, M.D., Study director, Center for Planned Surgery - Regionalhospital Silkeborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486420
- Sponsor's protocol ID
- M-20110157
- Status last verified
- Oct 2015
- First submitted
- 1 Dec 2011
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hansen RL, Lange J. Surgery versus ultrasound-guided steroid injections for trigger finger disease: protocol of a randomized controlled trial. Dan Med J. 2013 May;60(5):A4633.
PubMed 23673265
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Surgery Versus Ultrasound Guided Local Corticosteroid Injections in Treatment of Trigger Finger - a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01486420
- Acronym / sponsor ID
- M-20110157
- Conditions
- Trigger Finger
- Keywords
- Quinell grade, Open surgery, corticosteroid injections, randomized controlled trial, Trigger finger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Jeppe Lange, MDUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 6 Dec 2011 (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.
The purpose of the study is to investigate which strategy is superior in trigger finger Quinell grade IIb-V; conventional open surgery or ultrasound guided corticosteroid injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open surgery | Active comparator | Procedure: Open surgery |
| Corticosteroid Injection | Active comparator | Procedure: Corticosteroid injections |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Trigger finger Quinell grade IIb-V in digit I-V
Key exclusion criteria (8 listed)
- Former treatment of Trigger finger in affected digit
- Dupuytrens contracture in affected digit
- Allergies or intolerance to used medications
- Rheumatoid Arthritis
- Insulin dependent Diabetes Mellitus
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 |
|---|---|---|
| Corticosteroid injectionsCorticosteroid injections in and around A1-pulley. | Procedure or surgery | Corticosteroid Injection |
| Open surgeryOpen A1-pulley release | Procedure or surgery | Open surgery |
Primary outcome
Quinell grade
Time frame: 12 months
Dicotomized outcome defined as +/- failure. Failure defined as Quinell grade equal to or above IIb. Quinell grade defined as: I Normal movement, IIa normal movement with pain/tenderness to A1-pulley, IIb anamnestic triggering but not evident at clinical exam, III triggering without locking, IV triggering with locking but actively correctable, V Locked digit, passive correctable only.
2 secondary outcomes
Numerical Rating Scale (NRS) score
Time frame: 12 weeks
infection
Time frame: 12 weeks
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 28 Oct 2015.
- Derived from this study: PubMed 23673265Hansen RL, Lange J. Surgery versus ultrasound-guided steroid injections for trigger finger disease: protocol of a randomized controlled trial. Dan Med J. 2013 May;60(5):A4633.
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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.
Jeppe Lange, M.D. study director
Center for Planned Surgery - Regionalhospital Silkeborg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corticosteroid injections and Open surgery in people with Trigger Finger, run by Jeppe Lange, MD at 1 site in Denmark.
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 8 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 28 Oct 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 Denmark. 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?
Quinell grade (time frame: 12 months). 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 NCT01486420, 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 28 Oct 2015.