Efficacy of Ultrasound Guided Hyaluronic Injection in Tre... | NCT03131882

Studies
Efficacy of Ultrasound Guided Hyaluronic Injection in Treatment of Trigger Finger

NCT03131882

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

May 3, 2017Actual

Enrollment

120Estimated

Phase

Phase 2Phase 3

Conditions

Trigger Digit

Interventions

Hyaluronic Acid
Triamcinolone Acetonide

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2016Actual

Primary Completion Date

Jun 30, 2017Estimated

Completion Date

Sep 30, 2017Estimated

First Submitted Date

Apr 24, 2017

First Submission Date that Met QC Criteria

Apr 24, 2017

First Posted Date

Apr 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2017

Last Update Posted Date

May 3, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Comparing the Efficacy of Ultrasound Guided Hyaluronic Injection with Ultrasound Guided Corticosteroid Injection in Treatment of Trigger Finger

Detailed Description

Randomized controlled trial which designed to compare the success rate, recurrence rate and functional outcomes of patients with trigger finger whom was treated with ultrasound guided hyaluronic acid injection to ultrasound guided corticosteroid injection

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hyaluronic acid	Experimental	Hyaluronic acid	Drug: Hyaluronic Acid
Triamcinolone acetonide	Active Comparator	10mg/ml Triamcinolone acetonide	Drug: Triamcinolone Acetonide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyaluronic Acid	Drug	1 ml of Low molecular weight hyaluronic acid injection under ultrasound guidance after subcutaneous 0.5ml of 1%lidocaine injection	Hyaluronic acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success rate	reduction of symptom which needed no further treatment at follow up	1 month, 3 month, 6 months

Secondary Outcomes

Measure	Description	Time Frame
Pain score	Visual analogue scale changes	1 month, 3 month, 6 months
Functional outcome	Disability of the arm, shoulder and hand score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 20 years old
Quinnell grade I, II, III
Acute (< 6 months)

Exclusion Criteria:

Quinnell grade IV
Diabetes mellitus
Rheumatoid arthritis
Pregnancy
Patient with prior injection or surgery of trigger finger
Patient who are allergy to hyaluronic acid

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Picharn Pchyangkul, M.D.	Contact	+6685-1197710		ppicharn@hotmail.com
Thepparat Kanchanathepsak, M.D.	Contact	+662-2011589

Overall Officials

Name	Affiliation	Role
Thepparat Kanchanathepsak, M.D.	Ramathibodi Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine Ramathibodi hospital, Mahidol University	Recruiting	Ratchathewi	Bangkok	10400	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D052582	Trigger Finger Disorder

Ancestor Terms

ID	Term
D053682	Tendon Entrapment
D052256	Tendinopathy
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006820	Hyaluronic Acid
D014222	Triamcinolone Acetonide

Ancestor Terms

ID	Term
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates
D014221	Triamcinolone

Browse Leaves

Not provided

Browse Branches

Not provided