A Comparison Between Sonoguided Injection Corticosteroid and Hyaluronic Acid Injection in Treatment of Trigger Finger

November 2, 2014 updated by: Taipei Veterans General Hospital, Taiwan

Steroid Versus Hyaluronic Acid Ultrasound-guided Injection for Trigger Finger: A Comparative Study of Outcomes

The study is to compare the effect between steroid injection and Hyaluronic acid in treatment trigger finger. Using sonoguided injection technique achieves more accurate injection location and therapeutic effect. We hypothesize hyaluronic acid has both lubricant and anti-inflammation effect in treatment of trigger finger, and can provide better outcome and lower adverse effect than steroid injection.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a prospective, randomized, double-blinded controlled study. Patients with the diagnosis of trigger finger will be recruited and enrolled from Taipei Veteran General Hospital PM&R outpatient clinic. Subjects will be randomized into two groups; hyaluronic acid and triamcinolone acetonide injections, both via ultrasound-guided with one injection only.We hypothesize that through the anti-inflammatory property of the hyaluronate acid, the treatment effects will be as effective as the traditionally used steroid injections with equal or even lower recurrence rate for treatment of trigger finger. We expect that injections of hyaluronate into tendon sheath could become a new treatment option for trigger finger.

Study Type

Interventional

Enrollment (Actual)

36

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

      • Taipei, Taiwan
        • Taipei Veterans General Hospital

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with trigger digits and patients
  • without previous treatment of the trigger digit

Exclusion Criteria:

  • patients with prior treatment of the trigger digit (eg, splinting, injection, or therapy),
  • patients less than
  • 20 years old,
  • patients with allergy or contraindication to hyaluronic acid,
  • patients with trigger digits due to rheumatoid arthritis,
  • and patients with infection at the site of injection.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: steroid

used ultrasound-guided inject 1c.c triamcinolone acetonide 10mg/mL (Shincort®, YSP, Taiwan)into the sheath of the flexor tendons, penetrated to the A1 pulley.

One injection only

used ultrasound-guided inject 1c.c triamcinolone acetonide 10mg/mL (Shincort®, YSP, Taiwan)into the sheath of the flexor tendons, penetrated to the A1 pulley.

One injection only Steroid

Other Names:
  • triamcinolone acetonide 10mg/mL (Shincort®, YSP, Taiwan)
Experimental: Hyaluronic acid

used ultrasound-guided inject 1c.c Hyaluronic acid (Artz®, Seikagaku, Japan)into the sheath of the flexor tendons, penetrated to the A1 pulley.

One injection only

used ultrasound-guided inject 1c.c Hyaluronic acid (Artz®, Seikagaku, Japan)into the sheath of the flexor tendons, penetrated to the A1 pulley.

One injection only

Other Names:
  • Hyaluronic acid (Artz®, Seikagaku, Japan)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quinnell classification
Time Frame: Pre-injection; 3-weeks and 3-months post-injections

he Quinnell system grades trigger fingers as:

0 - normal movement

  1. - uneven movement
  2. - locking can be corrected with active motion
  3. - locking corrected with passive motion
  4. - unable to correct deformity
Pre-injection; 3-weeks and 3-months post-injections

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hand functional evaluation
Time Frame: Pre-injection; 3-weeks and 3-months post-injections
using the Michigan Hand Outcome Questionnaire (MHQ)
Pre-injection; 3-weeks and 3-months post-injections
visual analog scale
Time Frame: Pre-injection; 3-weeks and 3-months post-injections
Pre-injection; 3-weeks and 3-months post-injections
total active motion (TAM)
Time Frame: Pre-injection; 3-weeks and 3-months post-injections
Defi ned as the total ROM achieved when all three joints-metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) of a digit are actively fl exed or extended simultaneously, minus any extension defi cit at any of the three joints
Pre-injection; 3-weeks and 3-months post-injections
grip strength
Time Frame: Pre-injection; 3-weeks and 3-months post-injections
dynamometer strength test (JAMAR grip)
Pre-injection; 3-weeks and 3-months post-injections

Collaborators and Investigators

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

Investigators

  • Study Chair: Chung-Lan Kao, MD, PhD, Taipei Veterans General Hospital, Taiwan

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.

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

November 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

September 23, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (Estimate)

September 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 4, 2014

Last Update Submitted That Met QC Criteria

November 2, 2014

Last Verified

November 1, 2014

More Information

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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