NCT05261737

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

3.7 years

First QC Date

February 14, 2022

Last Update Submit

February 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    7 days

Interventions

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.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • \>21 years old

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

MeSH Terms

Conditions

De Quervain Disease

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Renita Sirisena

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2022

First Posted

March 2, 2022

Study Start

March 14, 2019

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations