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 Locations

  • Malaysia
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Recruiting
        • Chuah Sion Keat
        • Contact:

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
Device: 26 gauge needle
smaller gauge needle
Active Comparator: 23 gauge needle
control group
Device: 23 gauge needle
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

National University of Malaysia

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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