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

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Completed

CT.gov ID

NCT01950793

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Nov 1, 2012

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

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 Names: 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 Names: Hyaluronic acid (Artz®, Seikagaku, Japan)

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 Names:

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 Names:

Hyaluronic acid (Artz®, Seikagaku, Japan)

Outcome Measures

Primary Outcome Measures

Quinnell classification [Pre-injection; 3-weeks and 3-months post-injections]
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

Secondary Outcome Measures

hand functional evaluation [Pre-injection; 3-weeks and 3-months post-injections]
using the Michigan Hand Outcome Questionnaire (MHQ)
visual analog scale [Pre-injection; 3-weeks and 3-months post-injections]
total active motion (TAM) [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
grip strength [Pre-injection; 3-weeks and 3-months post-injections]
dynamometer strength test (JAMAR grip)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.