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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01950793
Other study ID # 2012-11-001A
Secondary ID
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


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
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