NCT01950793

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 4, 2014

Status Verified

November 1, 2014

Enrollment Period

1.5 years

First QC Date

September 23, 2013

Last Update Submit

November 2, 2014

Conditions

Trigger Finger

Keywords

Hyaluronic acid, trigger finger

Outcome Measures

Primary Outcomes (1)

  • Quinnell classification

    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

    Pre-injection; 3-weeks and 3-months post-injections

Secondary Outcomes (4)

  • hand functional evaluation

    Pre-injection; 3-weeks and 3-months post-injections

  • 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

  • grip strength

    Pre-injection; 3-weeks and 3-months post-injections

Study Arms (2)

steroid

ACTIVE COMPARATOR

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

Hyaluronic acid

EXPERIMENTAL

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

Interventions

triamcinolone acetonideDRUG

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

Also known as: triamcinolone acetonide 10mg/mL (Shincort®, YSP, Taiwan)
steroid
Hyaluronic AcidDRUG

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

Also known as: Hyaluronic acid (Artz®, Seikagaku, Japan)
Hyaluronic acid

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with trigger digits and patients
  • without previous treatment of the trigger digit

You may not qualify if:

  • patients with prior treatment of the trigger digit (eg, splinting, injection, or therapy),
  • patients less than
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • Liu DH, Tsai MW, Lin SH, Chou CL, Chiu JW, Chiang CC, Kao CL. Ultrasound-Guided Hyaluronic Acid Injections for Trigger Finger: A Double-Blinded, Randomized Controlled Trial. Arch Phys Med Rehabil. 2015 Dec;96(12):2120-7. doi: 10.1016/j.apmr.2015.08.421. Epub 2015 Sep 1.

    PMID: 26340807DERIVED

MeSH Terms

Conditions

Trigger Finger Disorder

Interventions

Triamcinolone AcetonideHyaluronic Acid

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Chung-Lan Kao, MD, PhD

    Taipei Veterans General Hospital, Taiwan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2013

First Posted

September 25, 2013

Study Start

November 1, 2012

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

November 4, 2014

Record last verified: 2014-11

Locations

TW(1)