- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03790969
Minimizing Pain Experience In Trigger Finger Steroid Injection.
March 11, 2019 updated by: CHUAH SION KEAT, National University of Malaysia
To study the pain experience of trigger finger steroid injection with 26 gauge needle as compared to 23 gauge needle.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
compare pain experience of trigger finger steroid injection between 26 gauge needle and 23 gauge needle.
Study Type
Interventional
Enrollment (Anticipated)
112
Phase
- Not Applicable
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
- Name: Chuah Sion Keat
- Phone Number: +617-3818580
- Email: cskeat@hotmail.com
Study Locations
-
-
Kuala Lumpur
-
Cheras, Kuala Lumpur, Malaysia, 56000
- Recruiting
- Chuah Sion Keat
-
Contact:
- CHUAH S KEAT
- Phone Number: 173818580
- Email: cskeat@hotmail.com
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 26 gauge needle
intervention group
|
smaller gauge needle
|
Active Comparator: 23 gauge needle
control group
|
control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
one minute after injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chuah Sion Keat
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)
January 15, 2019
Primary Completion (Anticipated)
November 30, 2019
Study Completion (Anticipated)
December 31, 2019
Study Registration Dates
First Submitted
December 29, 2018
First Submitted That Met QC Criteria
December 29, 2018
First Posted (Actual)
January 2, 2019
Study Record Updates
Last Update Posted (Actual)
March 13, 2019
Last Update Submitted That Met QC Criteria
March 11, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JEP-2018-654
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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