Minimizing Pain Experience In Trigger Finger Steroid Injection.
Primary Purpose
Trigger Finger
Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
26 gauge needle
23 gauge needle
Sponsored by
About this trial
This is an interventional supportive care trial for Trigger Finger focused on measuring steroid injection, pain, needle gauge, trigger finger
Eligibility Criteria
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
Sites / Locations
- Chuah Sion KeatRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
26 gauge needle
23 gauge needle
Arm Description
intervention group
control group
Outcomes
Primary Outcome Measures
Visual analog scale-pain
A numerical rating scale of 0 to 100, with 0 meaning no pain and 100 meaning the worst pain
Secondary Outcome Measures
Full Information
NCT ID
NCT03790969
First Posted
December 29, 2018
Last Updated
March 11, 2019
Sponsor
National University of Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT03790969
Brief Title
Minimizing Pain Experience In Trigger Finger Steroid Injection.
Official Title
Minimizing Pain Experience In Trigger Finger Steroid Injection.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Malaysia
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
To study the pain experience of trigger finger steroid injection with 26 gauge needle as compared to 23 gauge needle.
Detailed Description
compare pain experience of trigger finger steroid injection between 26 gauge needle and 23 gauge needle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger
Keywords
steroid injection, pain, needle gauge, trigger finger
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
26 gauge needle
Arm Type
Experimental
Arm Description
intervention group
Arm Title
23 gauge needle
Arm Type
Active Comparator
Arm Description
control group
Intervention Type
Device
Intervention Name(s)
26 gauge needle
Intervention Description
smaller gauge needle
Intervention Type
Device
Intervention Name(s)
23 gauge needle
Intervention Description
control group
Primary Outcome Measure Information:
Title
Visual analog scale-pain
Description
A numerical rating scale of 0 to 100, with 0 meaning no pain and 100 meaning the worst pain
Time Frame
one minute after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chuah Sion Keat
Phone
+617-3818580
Email
cskeat@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chuah Sion Keat
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chuah Sion Keat
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHUAH S KEAT
Phone
173818580
Email
cskeat@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Minimizing Pain Experience In Trigger Finger Steroid Injection.
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