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

Trigger Finger Clinical Trial

Official title:

Steroid Versus Hyaluronic Acid Ultrasound-guided Injection for Trigger Finger: A Comparative Study of Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01950793
• Other study ID #: 2012-11-001A
• Status: Completed
• Phase: N/A
• First received: September 23, 2013
• Last updated: November 2, 2014
• Start date: November 2012
• Est. completion date: August 2014

Study information

• Verified date: November 2014
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Trigger Finger
• Trigger Finger Disorder

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
• 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

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quinnell classification	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	Pre-injection; 3-weeks and 3-months post-injections	No
Secondary	hand functional evaluation	using the Michigan Hand Outcome Questionnaire (MHQ)	Pre-injection; 3-weeks and 3-months post-injections	No
Secondary	visual analog scale		Pre-injection; 3-weeks and 3-months post-injections	Yes
Secondary	total active motion (TAM)	De? ned as the total ROM achieved when all three joints—metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) of a digit are actively ? exed or extended simultaneously, minus any extension de? cit at any of the three joints	Pre-injection; 3-weeks and 3-months post-injections	No
Secondary	grip strength	dynamometer strength test (JAMAR grip)	Pre-injection; 3-weeks and 3-months post-injections	No