De Quervain DiseaseNCT05261737
Steroid Injection in De Quervain Tenosynovitis
An observational study of De Quervain Disease, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This study is carried out to find out the degree of pain relief achieved with standard treatment as steroid injection as well as its time to onset. It will recruit 50 subjects over a period of 18 months. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- De Quervain Disease
- What is being tested?
- Corticosteroid Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 14 Mar 2019to Dec 2022
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants of the study will be selected by attending physician in Hand and Reconstructive Microsurgery outpatient clinic. Estimated sample size is 50 patients.Statistical power calculation (error type II) is 0.8The Kaplan-Meier product-limit method will be used to estimate the rates of freedom from recurrence of symptoms. Confidence intervals for Kaplan-Meier survivorship functions will be based on Greenwood's variance estimated. A multivariable Cox proportional hazards regression model is planned to identify independent predictors of outcome.
Who may be able to join
- >21 years old
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Vanessa Wan, 67728237, vanessa_wan@nuhs.edu.sg
Renita Sirisena
About this study
Official title: Effectiveness of Steroid Injection in Treating Pain in De Quervain Tenosynovitis
This study is carried out to find out the degree of pain relief achieved with standard treatment as steroid injection as well as its time to onset. It will recruit 50 subjects over a period of 18 months.
Read the detailed description
The aim of the study is determine how effective these injections are and when will the patient start feeling relief of his/her symptoms.The aim of the study is not to change the current practice, but provide hand surgeons enough data to clarify their patients the expected outcomes and onset timing of the treatment performed.
- Conditions
- De Quervain Disease
- Being tested
- Corticosteroid Injection
- Medical subject headings
- De Quervain Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid InjectionProcedure or surgery
Steroid injection effectiveness will be determined by relief of pain scored by patient using Visual Analogue Scale (VAS). Data will be collected during clinic visit and contacting patients in a determined protocol for the following 6 weeks after steroid injection.After approval of the study, data will collected from participants over a period of 6 weeks follow up; the whole study will be conducted over a total of 2 years.Since the study will not conduct any further test to participants and follow up regimen will only state pain related to the specific condition (De Quervain tenosynovitis) and quick-DASH score, it will not result in any anticipated/unanticipated incidental findings, therefore participants will not be recontacted.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine efficacy of steroid injection
a single steroid injection over first dorsal compartment for patients diagnosed with de Quervain tenosynovitis will make effect within 7 days from injection, relieving pain to less or equal than 1 in Visual Analogue Scale (VAS)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start14 Mar 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for De Quervain DiseaseStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renita Sirisena, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261737
- Sponsor's protocol ID
- 2018/00787
- Other IDs
- 2018
- Status last verified
- Feb 2022
- First submitted
- 14 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Steroid Injection in Treating Pain in De Quervain Tenosynovitis
- ClinicalTrials.gov ID
- NCT05261737
- Acronym / sponsor ID
- 2018/00787
- Conditions
- De Quervain Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Mar 2022 (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.
This study is carried out to find out the degree of pain relief achieved with standard treatment as steroid injection as well as its time to onset. It will recruit 50 subjects over a period of 18 months.
Detailed description
The aim of the study is determine how effective these injections are and when will the patient start feeling relief of his/her symptoms.The aim of the study is not to change the current practice, but provide hand surgeons enough data to clarify their patients the expected outcomes and onset timing of the treatment performed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants of the study will be selected by attending physician in Hand and Reconstructive Microsurgery outpatient clinic. Estimated sample size is 50 patients.Statistical power calculation (error type II) is 0.8The Kaplan-Meier product-limit method will be used to estimate the rates of freedom from recurrence of symptoms. Confidence intervals for Kaplan-Meier survivorship functions will be based on Greenwood's variance estimated. A multivariable Cox proportional hazards regression model is planned to identify independent predictors of outcome.
Key inclusion criteria (1 listed)
- >21 years old
Key exclusion criteria (1 listed)
- Pregnancy
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 InjectionSteroid injection effectiveness will be determined by relief of pain scored by patient using Visual Analogue Scale (VAS). Data will be collected during clinic visit and contacting patients in a determined protocol for the following 6 weeks after steroid injection.After approval of the study, data will collected from participants over a period of 6 weeks follow up; the whole study will be conducted over a total of 2 years.Since the study will not conduct any further test to participants and follow up regimen will only state pain related to the specific condition (De Quervain tenosynovitis) and quick-DASH score, it will not result in any anticipated/unanticipated incidental findings, therefore participants will not be recontacted. | Procedure or surgery | – |
Primary outcome
Determine efficacy of steroid injection
Time frame: 7 days
a single steroid injection over first dorsal compartment for patients diagnosed with de Quervain tenosynovitis will make effect within 7 days from injection, relieving pain to less or equal than 1 in Visual Analogue Scale (VAS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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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.
Renita Sirisena principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of De Quervain Disease, run by National University Hospital, Singapore at 1 site in Singapore.
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 1 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 2 Mar 2022. 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 Singapore. 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 Vanessa Wan (67728237, vanessa_wan@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine efficacy of steroid injection (time frame: 7 days). 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 2 Mar 2022.