Steroid Injection in De Quervain Tenosynovitis

February 20, 2022 updated by: National University Hospital, Singapore

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 119074
        • Recruiting
        • National University Hospital
        • Contact:
        • Principal Investigator:
          • Renita Sirisena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • >21 years old

Exclusion Criteria:

  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Investigators

  • Principal Investigator: Renita Sirisena, National University Hospital, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2019

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

February 20, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 20, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/00787

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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