NCT03790969

Brief Summary

To study the pain experience of trigger finger steroid injection with 26 gauge needle as compared to 23 gauge needle.

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
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

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

First Submitted

Initial submission to the registry

December 29, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 2, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

11 months

First QC Date

December 29, 2018

Last Update Submit

March 11, 2019

Conditions

Trigger Finger

Keywords

steroid injectionpainneedle gaugetrigger finger

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

26 gauge needle

EXPERIMENTAL

intervention group

Device: 26 gauge needle

23 gauge needle

ACTIVE COMPARATOR

control group

Device: 23 gauge needle

Interventions

26 gauge needleDEVICE

smaller gauge needle

26 gauge needle
23 gauge needleDEVICE

control group

23 gauge needle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chuah Sion Keat

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

Trigger Finger DisorderPain

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chuah Sion Keat

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chuah Sion Keat

CONTACT

+617-3818580cskeat@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical officer

Study Record Dates

First Submitted

December 29, 2018

First Posted

January 2, 2019

Study Start

January 15, 2019

Primary Completion

November 30, 2019

Study Completion

December 31, 2019

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)