A Comparison Between Sonoguided Injection Corticosteroid and Hyaluronic Acid Injection in Treatment of Trigger Finger
Primary Purpose
Trigger Finger
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
triamcinolone acetonide
Hyaluronic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Trigger Finger focused on measuring Hyaluronic acid, trigger finger
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.
Sites / Locations
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
steroid
Hyaluronic acid
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
hand functional evaluation
using the Michigan Hand Outcome Questionnaire (MHQ)
visual analog scale
total active motion (TAM)
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
dynamometer strength test (JAMAR grip)
Full Information
NCT ID
NCT01950793
First Posted
September 23, 2013
Last Updated
November 2, 2014
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT01950793
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger
Keywords
Hyaluronic acid, trigger finger
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
steroid
Arm Type
Active Comparator
Arm Description
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
Arm Title
Hyaluronic acid
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
triamcinolone acetonide
Other Intervention Name(s)
triamcinolone acetonide 10mg/mL (Shincort®, YSP, Taiwan)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Hyaluronic Acid
Other Intervention Name(s)
Hyaluronic acid (Artz®, Seikagaku, Japan)
Intervention Description
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
Primary Outcome Measure Information:
Title
Quinnell classification
Description
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
Time Frame
Pre-injection; 3-weeks and 3-months post-injections
Secondary Outcome Measure Information:
Title
hand functional evaluation
Description
using the Michigan Hand Outcome Questionnaire (MHQ)
Time Frame
Pre-injection; 3-weeks and 3-months post-injections
Title
visual analog scale
Time Frame
Pre-injection; 3-weeks and 3-months post-injections
Title
total active motion (TAM)
Description
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
Time Frame
Pre-injection; 3-weeks and 3-months post-injections
Title
grip strength
Description
dynamometer strength test (JAMAR grip)
Time Frame
Pre-injection; 3-weeks and 3-months post-injections
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung-Lan Kao, MD, PhD
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
26340807
Citation
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.
Results Reference
derived
Learn more about this trial
A Comparison Between Sonoguided Injection Corticosteroid and Hyaluronic Acid Injection in Treatment of Trigger Finger
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