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

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ClinicalTrials.gov Identifier: NCT01950793
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : November 4, 2014
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Trigger Finger Drug: triamcinolone acetonide Drug: Hyaluronic Acid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Steroid Versus Hyaluronic Acid Ultrasound-guided Injection for Trigger Finger: A Comparative Study of Outcomes
Study Start Date : November 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : August 2014


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

Drug: triamcinolone acetonide

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 Name: 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

Drug: 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

Other Name: Hyaluronic acid (Artz®, Seikagaku, Japan)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. hand functional evaluation [ Time Frame: Pre-injection; 3-weeks and 3-months post-injections ]
    using the Michigan Hand Outcome Questionnaire (MHQ)

  2. visual analog scale [ Time Frame: Pre-injection; 3-weeks and 3-months post-injections ]
  3. 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

  4. grip strength [ Time Frame: Pre-injection; 3-weeks and 3-months post-injections ]
    dynamometer strength test (JAMAR grip)



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT01950793


Locations
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Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Study Chair: Chung-Lan Kao, MD, PhD Taipei Veterans General Hospital, Taiwan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT01950793     History of Changes
Other Study ID Numbers: 2012-11-001A
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: November 2014

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Hyaluronic acid, trigger finger

Additional relevant MeSH terms:
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Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
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