Trigger FingerNCT03790969
Minimizing Pain Experience In Trigger Finger Steroid Injection.
A study testing 26 gauge needle and 23 gauge needle in people with Trigger Finger, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
To study the pain experience of trigger finger steroid injection with 26 gauge needle as compared to 23 gauge needle. 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?
- 26 gauge needle and 23 gauge needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Jan 2019to 31 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 year old
- Male or female(non-pregnant)
- Single trigger finger
- Clinically diagnosed trigger finger- Green classification Grade I or II
- No prior surgery to the involved finger
- Subject is able to provide voluntary, written informed consent
Who cannot join
- Age less than 18 year old
- Allergy to lignocaine or corticosteroid
- Trigger finger with Green classification grade III or IV
- Previous surgery on the affected finger
- Any wound, neurovascular injury, or skin disease at injection site
- Concomitant ipsilateral fingers/wrist/forearm/arm injury
- Preexisting congenital/acquired deformities of hand (such as rheumatoid arthritis, contracture)
- Insensate hand
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Chuah Sion Keat
Cheras, Kuala Lumpur, 56000
CHUAH S KEAT, 173818580, cskeat@hotmail.com
About this study
To study the pain experience of trigger finger steroid injection with 26 gauge needle as compared to 23 gauge needle.
Read the detailed description
compare pain experience of trigger finger steroid injection between 26 gauge needle and 23 gauge needle.
- Conditions
- Trigger Finger
- Being tested
- 26 gauge needle, 23 gauge needle
- Keywords
- steroid injection, pain, needle gauge, trigger finger
- Medical subject headings
- Trigger Finger Disorder, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
26 gauge needleDevice
smaller gauge needle
23 gauge needleDevice
control group
| Study group | Role | What they receive |
|---|---|---|
| 26 gauge needle | Experimental | intervention group Receives: Device: 26 gauge needle |
| 23 gauge needle | Active comparator | control group Receives: Device: 23 gauge needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale-pain
A numerical rating scale of 0 to 100, with 0 meaning no pain and 100 meaning the worst pain
Measured: one minute after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start15 Jan 2019
- Primary completion30 Nov 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHUAH SION KEAT, National University of Malaysia
- Investigators
- Chuah Sion Keat, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790969
- Sponsor's protocol ID
- JEP-2018-654
- Status last verified
- Mar 2019
- First submitted
- 29 Dec 2018
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Pain Experience In Trigger Finger Steroid Injection.
- ClinicalTrials.gov ID
- NCT03790969
- Acronym / sponsor ID
- JEP-2018-654
- Conditions
- Trigger Finger
- Keywords
- steroid injection, pain, needle gauge, trigger finger
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 2 Jan 2019 (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.
To study the pain experience of trigger finger steroid injection with 26 gauge needle as compared to 23 gauge needle.
Detailed description
compare pain experience of trigger finger steroid injection between 26 gauge needle and 23 gauge needle.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 26 gauge needle | Experimental | Device: 26 gauge needleintervention group |
| 23 gauge needle | Active comparator | Device: 23 gauge needlecontrol group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age above 18 year old
- Male or female(non-pregnant)
- Single trigger finger
- Clinically diagnosed trigger finger- Green classification Grade I or II
- No prior surgery to the involved finger
Key exclusion criteria (8 listed)
- Age less than 18 year old
- Allergy to lignocaine or corticosteroid
- Trigger finger with Green classification grade III or IV
- Previous surgery on the affected finger
- Any wound, neurovascular injury, or skin disease at injection site
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 |
|---|---|---|
| 26 gauge needlesmaller gauge needle | Device | 26 gauge needle |
| 23 gauge needlecontrol group | Device | 23 gauge needle |
Primary outcome
Visual analog scale-pain
Time frame: one minute after injection
A numerical rating scale of 0 to 100, with 0 meaning no pain and 100 meaning the worst pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- 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. This study is not recruiting at the moment.
Chuah Sion Keat principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 26 gauge needle and 23 gauge needle in people with Trigger Finger, run by National University of Malaysia at 1 site in Malaysia.
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 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: status not confirmed, as of the sponsor's last update on 13 Mar 2019. 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 Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuah Sion Keat (+617-3818580, cskeat@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale-pain (time frame: one minute after injection). 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 13 Mar 2019.