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Efficacy of Ultrasound Guided Hyaluronic Injection in Treatment of Trigger Finger

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ClinicalTrials.gov Identifier: NCT03131882
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Mahidol University

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

Condition or disease Intervention/treatment Phase
Trigger Digit Drug: Hyaluronic Acid Drug: Triamcinolone Acetonide Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection With Ultrasound Guided Corticosteroid Injection in Treatment of Trigger Finger
Actual Study Start Date : October 1, 2016
Estimated Primary Completion Date : June 30, 2017
Estimated Study Completion Date : September 30, 2017


Arm Intervention/treatment
Experimental: Hyaluronic acid
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 Name: 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 Name: Shincort inj.




Primary Outcome Measures :
  1. Success rate [ Time Frame: 1 month, 3 month, 6 months ]
    reduction of symptom which needed no further treatment at follow up


Secondary Outcome Measures :
  1. Pain score [ Time Frame: 1 month, 3 month, 6 months ]
    Visual analogue scale changes

  2. Functional outcome [ Time Frame: 1 month, 3 months, 6 months ]
    Disability of the arm, shoulder and hand score



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131882


Contacts
Contact: Picharn Pchyangkul, M.D. +6685-1197710 ppicharn@hotmail.com
Contact: Thepparat Kanchanathepsak, M.D. +662-2011589

Locations
Thailand
Faculty of medicine Ramathibodi hospital, Mahidol University Recruiting
Ratchathewi, Bangkok, Thailand, 10400
Contact: Picharn Pichyangkul, M.D.    +6685-1197710    ppicharn@hotmail.com   
Sub-Investigator: Picharn Pichyangkul, M.D.         
Principal Investigator: Thepparat Kanchanathepsak, M.D.         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Thepparat Kanchanathepsak, M.D. Faculty of medicine Ramathibodi hospital, Mahidol university

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT03131882     History of Changes
Other Study ID Numbers: 05-58-04
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Mahidol University:
trigger finger
trigger thumb
ultrasound guided
hyaluronic acid

Additional relevant MeSH terms:
Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Hyaluronic Acid
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Viscosupplements
Protective Agents