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

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

Overview[ - collapse ][ - ]

Purpose	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	Trigger Finger
Intervention	Drug: triamcinolone acetonide Drug: Hyaluronic Acid
Phase	N/A
Sponsor	Taipei Veterans General Hospital, Taiwan
Responsible Party	Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier	NCT01950793
First Received	September 23, 2013
Last Updated	September 24, 2013
Last verified	August 2012

Tracking Information[ + expand ][ + ]

First Received Date	September 23, 2013
Last Updated Date	September 24, 2013
Start Date	November 2012
Estimated Primary Completion Date	December 2013
Current Primary Outcome Measures	Quinnell classification [Time Frame: Pre-injection; 3-weeks and 3-months post-injections] [Designated as safety issue: No]he Quinnell system grades trigger fingers as: 0 - normal movement - uneven movement - locking can be corrected with active motion - locking corrected with passive motion - unable to correct deformity
Current Secondary Outcome Measures	hand functional evaluation [Time Frame: Pre-injection; 3-weeks and 3-months post-injections] [Designated as safety issue: No]using the Michigan Hand Outcome Questionnaire (MHQ) visual analog scale [Time Frame: Pre-injection; 3-weeks and 3-months post-injections] [Designated as safety issue: Yes] total active motion (TAM) [Time Frame: Pre-injection; 3-weeks and 3-months post-injections] [Designated as safety issue: No]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 grip strength [Time Frame: Pre-injection; 3-weeks and 3-months post-injections] [Designated as safety issue: No]dynamometer strength test (JAMAR grip)

Descriptive Information[ + expand ][ + ]

Brief Title	A Comparison Between Sonoguided Injection Corticosteroid and Hyaluronic Acid Injection in Treatment of Trigger Finger
Official Title	Steroid Versus Hyaluronic Acid Ultrasound-guided Injection for Trigger Finger: A Comparative Study of Outcomes
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.
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
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Condition	Trigger Finger
Intervention	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 Names: triamcinolone acetonide 10mg/mL (Shincort®, YSP, Taiwan)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 Names: Hyaluronic acid (Artz®, Seikagaku, Japan)
Study Arm (s)	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 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

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	80
Estimated Completion Date	December 2013
Estimated Primary Completion Date	November 2013
Eligibility 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.
Gender	Both
Ages	20 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Taiwan

Administrative Information[ + expand ][ + ]

NCT Number	NCT01950793
Other Study ID Numbers	2012-11-001A
Has Data Monitoring Committee	Yes
Information Provided By	Taipei Veterans General Hospital, Taiwan
Study Sponsor	Taipei Veterans General Hospital, Taiwan
Collaborators	Not Provided
Investigators	Study Chair: Chung-Lan Kao, MD, PhD Taipei Veterans General Hospital, Taiwan
Verification Date	August 2012

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