Minimizing Pain Experience In Trigger Finger Steroid Inje... | NCT03790969

Studies
Minimizing Pain Experience In Trigger Finger Steroid Injection.

NCT03790969

Sponsor

National University of Malaysia

Status

Unknown status

Last Update Posted

Mar 13, 2019Actual

Enrollment

112Estimated

Phase

Not Applicable

Conditions

Trigger Finger

Interventions

26 gauge needle
23 gauge needle

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2019Actual

Primary Completion Date

Nov 30, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Dec 29, 2018

First Submission Date that Met QC Criteria

Dec 29, 2018

First Posted Date

Jan 2, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2019

Last Update Posted Date

Mar 13, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

CHUAH SION KEAT, medical officer, National University of MalaysiaPrincipal Investigator

Lead Sponsor

National University of MalaysiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

112Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
26 gauge needle	Experimental	intervention group	Device: 26 gauge needle
23 gauge needle	Active Comparator	control group	Device: 23 gauge needle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
26 gauge needle	Device	smaller gauge needle	26 gauge needle
23 gauge needle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual analog scale-pain	A numerical rating scale of 0 to 100, with 0 meaning no pain and 100 meaning the worst pain	one minute after injection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chuah Sion Keat	Contact	+617-3818580		cskeat@hotmail.com

Overall Officials

Name	Affiliation	Role
Chuah Sion Keat		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chuah Sion Keat	Recruiting	Cheras	Kuala Lumpur	56000	Malaysia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D052582	Trigger Finger Disorder
D010146	Pain

Ancestor Terms

ID	Term
D053682	Tendon Entrapment
D052256	Tendinopathy
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided