Trigger DigitPhase 2/3NCT03131882
Efficacy of Ultrasound Guided Hyaluronic Injection in Treatment of Trigger Finger
A Phase 2/3 study testing Hyaluronic Acid and Triamcinolone Acetonide in people with Trigger Digit, run by Mahidol University at 1 site in Thailand.
Trial summary
Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection with Ultrasound Guided Corticosteroid Injection in Treatment of Trigger Finger Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Trigger Digit
- What is being tested?
- Hyaluronic Acid and Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2016to 30 Sep 2017
- Phase
- Phase 2/3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 20 years old
- Quinnell grade I, II, III
- Acute (< 6 months)
Who cannot join
- Quinnell grade IV
- Diabetes mellitus
- Rheumatoid arthritis
- Pregnancy
- Patient with prior injection or surgery of trigger finger
- Patient who are allergy to hyaluronic acid
Trial locations and contacts
1 site in 1 country.
Thepparat Kanchanathepsak, M.D. contact
Thailand1 site, 1 recruiting
- Recruiting
Faculty of medicine Ramathibodi hospital, Mahidol University
Ratchathewi, Bangkok, 10400
Picharn Pichyangkul, M.D., +6685-1197710, ppicharn@hotmail.com
Picharn Pichyangkul, M.D.
About this study
Official title: Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection With Ultrasound Guided Corticosteroid Injection in Treatment of Trigger Finger
Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection with Ultrasound Guided Corticosteroid Injection in Treatment of Trigger Finger
Read the detailed description
Randomized controlled trial which designed to compare the success rate, recurrence rate and functional outcomes of patients with trigger finger whom was treated with ultrasound guided hyaluronic acid injection to ultrasound guided corticosteroid injection
- Conditions
- Trigger Digit
- Being tested
- Hyaluronic Acid, Triamcinolone Acetonide
- Keywords
- trigger finger, trigger thumb, ultrasound guided, hyaluronic acid
- 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.
Hyaluronic AcidDrug
Also called Hyalgan
1 ml of Low molecular weight hyaluronic acid injection under ultrasound guidance after subcutaneous 0.5ml of 1%lidocaine injection
Triamcinolone AcetonideDrug
Also called Shincort inj.
1ml of 10 mg of triamcinolone injection under ultrasound guidance after subcutaneous 0.5 ml 1%lidocaine injection
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid | Experimental | Hyaluronic acid Receives: Drug: Hyaluronic Acid |
| Triamcinolone acetonide | Active comparator | 10mg/ml Triamcinolone acetonide Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
reduction of symptom which needed no further treatment at follow up
Measured: 1 month, 3 month, 6 months
Secondary outcomes (2)
Pain score
Visual analogue scale changes
Measured: 1 month, 3 month, 6 months
Functional outcome
Disability of the arm, shoulder and hand score
Measured: 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start1 Oct 2016
- Primary completion30 Jun 2017 (estimated)
- Study completion30 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger DigitStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thepparat Kanchanathepsak, M.D., Principal investigator, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131882
- Sponsor's protocol ID
- 05-58-04
- Status last verified
- May 2017
- First submitted
- 24 Apr 2017
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection With Ultrasound Guided Corticosteroid Injection in Treatment of Trigger Finger
- ClinicalTrials.gov ID
- NCT03131882
- Acronym / sponsor ID
- 05-58-04
- Conditions
- Trigger Digit
- Keywords
- trigger finger, trigger thumb, ultrasound guided, hyaluronic acid
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Jun 2017 (estimated)
- Study completion
- 30 Sep 2017 (estimated)
- First posted
- 27 Apr 2017 (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.
Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection with Ultrasound Guided Corticosteroid Injection in Treatment of Trigger Finger
Detailed description
Randomized controlled trial which designed to compare the success rate, recurrence rate and functional outcomes of patients with trigger finger whom was treated with ultrasound guided hyaluronic acid injection to ultrasound guided corticosteroid injection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid | Experimental | Drug: Hyaluronic AcidHyaluronic acid |
| Triamcinolone acetonide | Active comparator | Drug: Triamcinolone Acetonide10mg/ml Triamcinolone acetonide |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 20 years old
- Quinnell grade I, II, III
- Acute (< 6 months)
Key exclusion criteria (6 listed)
- Quinnell grade IV
- Diabetes mellitus
- Rheumatoid arthritis
- Pregnancy
- Patient with prior injection or surgery of trigger finger
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 |
|---|---|---|
| Hyaluronic AcidAlso: Hyalgan1 ml of Low molecular weight hyaluronic acid injection under ultrasound guidance after subcutaneous 0.5ml of 1%lidocaine injection | Drug | Hyaluronic acid |
| Triamcinolone AcetonideAlso: Shincort inj.1ml of 10 mg of triamcinolone injection under ultrasound guidance after subcutaneous 0.5 ml 1%lidocaine injection | Drug | Triamcinolone acetonide |
Primary outcome
Success rate
Time frame: 1 month, 3 month, 6 months
reduction of symptom which needed no further treatment at follow up
2 secondary outcomes
Pain score
Time frame: 1 month, 3 month, 6 months
Functional outcome
Time frame: 1 month, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- 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.
Thepparat Kanchanathepsak, M.D. contact
Thepparat Kanchanathepsak, M.D. principal investigator
Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hyaluronic Acid and Triamcinolone Acetonide in people with Trigger Digit, run by Mahidol University 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: status not confirmed, as of the sponsor's last update on 3 May 2017. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Picharn Pchyangkul, M.D. (+6685-1197710, ppicharn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: 1 month, 3 month, 6 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 3 May 2017.