Efficacy of Ultrasound Guided Hyaluronic Injection in Treatment of Trigger Finger

May 1, 2017 updated by: Mahidol University

Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection With Ultrasound Guided Corticosteroid Injection in Treatment of Trigger Finger

Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection with Ultrasound Guided Corticosteroid Injection in Treatment of Trigger Finger

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Randomized controlled trial which designed to compare the success rate, recurrence rate and functional outcomes of patients with trigger finger whom was treated with ultrasound guided hyaluronic acid injection to ultrasound guided corticosteroid injection

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Thepparat Kanchanathepsak, M.D.
  • Phone Number: +662-2011589

Study Locations

  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Recruiting
        • Faculty of Medicine Ramathibodi Hospital, Mahidol University
        • Contact:
        • Sub-Investigator:
          • Picharn Pichyangkul, M.D.
        • Principal Investigator:
          • Thepparat Kanchanathepsak, M.D.

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 20 years old
  • Quinnell grade I, II, III
  • Acute (< 6 months)

Exclusion Criteria:

  • Quinnell grade IV
  • Diabetes mellitus
  • Rheumatoid arthritis
  • Pregnancy
  • Patient with prior injection or surgery of trigger finger
  • Patient who are allergy to hyaluronic acid

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronic acid
Drug: Hyaluronic Acid
1 ml of Low molecular weight hyaluronic acid injection under ultrasound guidance after subcutaneous 0.5ml of 1%lidocaine injection
Other Names:
  • Hyalgan
Active Comparator: Triamcinolone acetonide
10mg/ml Triamcinolone acetonide
Drug: Triamcinolone Acetonide
1ml of 10 mg of triamcinolone injection under ultrasound guidance after subcutaneous 0.5 ml 1%lidocaine injection
Other Names:
  • Shincort inj.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate
Time Frame: 1 month, 3 month, 6 months
reduction of symptom which needed no further treatment at follow up
1 month, 3 month, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: 1 month, 3 month, 6 months
Visual analogue scale changes
1 month, 3 month, 6 months
Functional outcome
Time Frame: 1 month, 3 months, 6 months
Disability of the arm, shoulder and hand score
1 month, 3 months, 6 months

Collaborators and Investigators

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

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Thepparat Kanchanathepsak, M.D., Faculty of Medicine Ramathibodi Hospital, Mahidol University

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)

October 1, 2016

Primary Completion (Anticipated)

June 30, 2017

Study Completion (Anticipated)

September 30, 2017

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

April 24, 2017

First Posted (Actual)

April 27, 2017

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-58-04

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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