Open Surgery Versus Corticosteroid Injections in Treatment of Trigger Finger

October 27, 2015 updated by: Jeppe Lange, MD

Open Surgery Versus Ultrasound Guided Local Corticosteroid Injections in Treatment of Trigger Finger - a Randomized Controlled Trial.

The purpose of the study is to investigate which strategy is superior in trigger finger Quinell grade IIb-V; conventional open surgery or ultrasound guided corticosteroid injections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

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

  • Denmark
      • Silkeborg, Denmark, 8600
        • Center for Planned surgery - Regionalhospital Silkeborg

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Trigger finger Quinell grade IIb-V in digit I-V

Exclusion Criteria:

  • Former treatment of Trigger finger in affected digit
  • Dupuytrens contracture in affected digit
  • Allergies or intolerance to used medications
  • Rheumatoid Arthritis
  • Insulin dependent Diabetes Mellitus
  • Amyloidosis
  • Mucopolysaccharidosis
  • Already included in study with another digit

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Open surgery
Procedure: Open surgery
Open A1-pulley release
Active Comparator: Corticosteroid Injection
Procedure: Corticosteroid injections
Corticosteroid injections in and around A1-pulley.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quinell grade
Time Frame: 12 months

Dicotomized outcome defined as +/- failure. Failure defined as Quinell grade equal to or above IIb.

Quinell grade defined as: I Normal movement, IIa normal movement with pain/tenderness to A1-pulley, IIb anamnestic triggering but not evident at clinical exam, III triggering without locking, IV triggering with locking but actively correctable, V Locked digit, passive correctable only.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale (NRS) score
Time Frame: 12 weeks
Pain following either procedure measured by NRS (score 0-10, 10 is severe pain)
12 weeks
infection
Time Frame: 12 weeks
Infection occurence following either procedure
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeppe Lange, MD

Investigators

  • Study Director: Jeppe Lange, M.D., Center for Planned surgery - Regionalhospital Silkeborg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

December 1, 2011

First Submitted That Met QC Criteria

December 3, 2011

First Posted (Estimate)

December 6, 2011

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 27, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-20110157

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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