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Efficacy of Ultrasound Guided Hyaluronic Injection in Treatment of Trigger Finger

Primary Purpose

Trigger Digit

Status
Unknown status
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Hyaluronic Acid
Triamcinolone Acetonide
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Digit focused on measuring trigger finger, trigger thumb, ultrasound guided, hyaluronic acid

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of medicine Ramathibodi hospital, Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hyaluronic acid

Triamcinolone acetonide

Arm Description

Hyaluronic acid

10mg/ml Triamcinolone acetonide

Outcomes

Primary Outcome Measures

Success rate
reduction of symptom which needed no further treatment at follow up

Secondary Outcome Measures

Pain score
Visual analogue scale changes
Functional outcome
Disability of the arm, shoulder and hand score

Full Information

First Posted
April 24, 2017
Last Updated
May 1, 2017
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT03131882
Brief Title
Efficacy of Ultrasound Guided Hyaluronic Injection in Treatment of Trigger Finger
Official Title
Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection With Ultrasound Guided Corticosteroid Injection in Treatment of Trigger Finger
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Anticipated)
Study Completion Date
September 30, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Digit
Keywords
trigger finger, trigger thumb, ultrasound guided, hyaluronic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyaluronic acid
Arm Type
Experimental
Arm Description
Hyaluronic acid
Arm Title
Triamcinolone acetonide
Arm Type
Active Comparator
Arm Description
10mg/ml Triamcinolone acetonide
Intervention Type
Drug
Intervention Name(s)
Hyaluronic Acid
Other Intervention Name(s)
Hyalgan
Intervention Description
1 ml of Low molecular weight hyaluronic acid injection under ultrasound guidance after subcutaneous 0.5ml of 1%lidocaine injection
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
Shincort inj.
Intervention Description
1ml of 10 mg of triamcinolone injection under ultrasound guidance after subcutaneous 0.5 ml 1%lidocaine injection
Primary Outcome Measure Information:
Title
Success rate
Description
reduction of symptom which needed no further treatment at follow up
Time Frame
1 month, 3 month, 6 months
Secondary Outcome Measure Information:
Title
Pain score
Description
Visual analogue scale changes
Time Frame
1 month, 3 month, 6 months
Title
Functional outcome
Description
Disability of the arm, shoulder and hand score
Time Frame
1 month, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Picharn Pchyangkul, M.D.
Phone
+6685-1197710
Email
ppicharn@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Thepparat Kanchanathepsak, M.D.
Phone
+662-2011589
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thepparat Kanchanathepsak, M.D.
Organizational Affiliation
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine Ramathibodi hospital, Mahidol University
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Picharn Pichyangkul, M.D.
Phone
+6685-1197710
Email
ppicharn@hotmail.com
First Name & Middle Initial & Last Name & Degree
Picharn Pichyangkul, M.D.
First Name & Middle Initial & Last Name & Degree
Thepparat Kanchanathepsak, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Ultrasound Guided Hyaluronic Injection in Treatment of Trigger Finger

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