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Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger

Primary Purpose

Trigger Finger

Status
Unknown status
Phase
Early Phase 1
Locations
United Arab Emirates
Study Type
Interventional
Intervention
hyaluronic acid (20 mg/2 mL)
Triamcinolone acetonide 10mg/ml
Sponsored by
Dubai Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Finger focused on measuring Trigger finger, Hyaluronic Acid, Corticosteroid, Ultrasound-guided injection

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult (>18 years)
  • Patients with a clinical diagnosis of trigger finger grade 1-3 on the Quinnell grading scale and confirmed diagnosis by ultrasound.

Exclusion Criteria:

  • Quinnell's classification grade IV (contracture)
  • Prior injection within 6 months
  • Prior operation of the affected finger
  • Presence of any contracture in the proximal interphalangeal or metacarpophalangeal joint, and
  • History of diabetes, hypothyroidism, and
  • Rheumatic or connective tissue disease
  • Allergy to triamcinolone or hyaluronic acid
  • Pregnancy
  • Secondary triggering e.g. Trauma, infection
  • Trigger finger symptoms duration >6 months

Sites / Locations

  • Dubai Hospital- Dubai Health AuthorityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hyaluronic acid

Triamcinolone acetonide

Arm Description

1mL of hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) infiltration at A1-Pulley under ultrasound guidance after subcutaneous 2% lidocaine without epinephrine infiltration of the skin overlying the A1-pulley.

1 mL of Triamcinolone acetonide 10mg/ml infiltration at A1-Pulley under ultrasound guidance after subcutaneous 2% lidocaine without epinephrine infiltration of the skin overlying the A1 pulley.

Outcomes

Primary Outcome Measures

Change in Quinnell trigger finger grading system:
Change in Quinnell grading overtime within 3 months after injection. Trigger fingers are rated as follows: Grade 0: normal finger movements, Grade 1: uneven finger movements, Grade 2: actively correctable triggering, Grade 3: passively correctable triggering, and Grade 4: locked digit.

Secondary Outcome Measures

Visual analogue scale (VAS) of pain
Change in pain Visual analogue scale will be recorded. The patient marks on the 100 mm in length line the point that he/she feels to represent his/her perception of pain at the current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks ( a higher score indicates greater pain intensity). Categorization of none, mild, moderate and severe pain will be also used (none = 0, mild = 1-4, moderate = 5-6, and severe = 7-10).
Frequency of tender trigger nodules
Identifying the presence of tender nodules at A1-pulley of the affected finger by palpation
The Quick Disability of the Arm, Shoulder and Hand score
Patients will be asked to fill a questionnaire form. It is an 11-item form that assesses the upper limb function on a scale of 1-5, with scores ranging from 11 to 55, with the higher scores representing more disability and worse upper limb function.
Changes in Grip strength
Measured by the dynamometer strength test (Jamar grip dynamometer)
Patient satisfaction with therapy
Participating patients will be asked to classify their result into 1 of 4 categories: (1) complete resolution of symptoms, (2) improved result, but incomplete resolution of symptoms, not warranting further treatment, (3) partial response, but unsatisfactory, warranting further treatment, and (4) no response.
Ultrasound evaluation of A1-Pulley
Detailed ultrasonography evaluation of A1-Pulley. Comparing the A1-Pulley ultrasonographic parameters over 3 months after injection (at the follow-up appointment)

Full Information

First Posted
November 4, 2020
Last Updated
November 25, 2020
Sponsor
Dubai Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT04645303
Brief Title
Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger
Official Title
Ultrasound-Guided Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 6, 2020 (Actual)
Primary Completion Date
April 5, 2021 (Anticipated)
Study Completion Date
June 4, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dubai Health Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the study is to compare the therapeutic effects of hyaluronic acid versus steroid injections in treating trigger fingers using ultrasound guidance
Detailed Description
A prospective randomized controlled study designed to compare the outcomes of injecting patients with trigger finger with hyaluronic acid versus corticosteroid under ultrasound guidance

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger
Keywords
Trigger finger, Hyaluronic Acid, Corticosteroid, Ultrasound-guided injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyaluronic acid
Arm Type
Experimental
Arm Description
1mL of hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) infiltration at A1-Pulley under ultrasound guidance after subcutaneous 2% lidocaine without epinephrine infiltration of the skin overlying the A1-pulley.
Arm Title
Triamcinolone acetonide
Arm Type
Active Comparator
Arm Description
1 mL of Triamcinolone acetonide 10mg/ml infiltration at A1-Pulley under ultrasound guidance after subcutaneous 2% lidocaine without epinephrine infiltration of the skin overlying the A1 pulley.
Intervention Type
Drug
Intervention Name(s)
hyaluronic acid (20 mg/2 mL)
Other Intervention Name(s)
Hyalgan 20 mg in 2 ML Prefilled Syringe
Intervention Description
A1-Pulley infiltration for trigger finger
Intervention Type
Drug
Intervention Name(s)
Triamcinolone acetonide 10mg/ml
Other Intervention Name(s)
Kenalog 10 mg/ml
Intervention Description
A1-Pulley infiltration for trigger finger
Primary Outcome Measure Information:
Title
Change in Quinnell trigger finger grading system:
Description
Change in Quinnell grading overtime within 3 months after injection. Trigger fingers are rated as follows: Grade 0: normal finger movements, Grade 1: uneven finger movements, Grade 2: actively correctable triggering, Grade 3: passively correctable triggering, and Grade 4: locked digit.
Time Frame
1 and 3 months post-injection
Secondary Outcome Measure Information:
Title
Visual analogue scale (VAS) of pain
Description
Change in pain Visual analogue scale will be recorded. The patient marks on the 100 mm in length line the point that he/she feels to represent his/her perception of pain at the current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks ( a higher score indicates greater pain intensity). Categorization of none, mild, moderate and severe pain will be also used (none = 0, mild = 1-4, moderate = 5-6, and severe = 7-10).
Time Frame
1 and 3 months post-injection
Title
Frequency of tender trigger nodules
Description
Identifying the presence of tender nodules at A1-pulley of the affected finger by palpation
Time Frame
1 and 3 months post-injection
Title
The Quick Disability of the Arm, Shoulder and Hand score
Description
Patients will be asked to fill a questionnaire form. It is an 11-item form that assesses the upper limb function on a scale of 1-5, with scores ranging from 11 to 55, with the higher scores representing more disability and worse upper limb function.
Time Frame
1 and 3 months post-injection
Title
Changes in Grip strength
Description
Measured by the dynamometer strength test (Jamar grip dynamometer)
Time Frame
1 and 3 months post-injection
Title
Patient satisfaction with therapy
Description
Participating patients will be asked to classify their result into 1 of 4 categories: (1) complete resolution of symptoms, (2) improved result, but incomplete resolution of symptoms, not warranting further treatment, (3) partial response, but unsatisfactory, warranting further treatment, and (4) no response.
Time Frame
1 and 3 months post-injection
Title
Ultrasound evaluation of A1-Pulley
Description
Detailed ultrasonography evaluation of A1-Pulley. Comparing the A1-Pulley ultrasonographic parameters over 3 months after injection (at the follow-up appointment)
Time Frame
1 and 3 months post-injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (>18 years) Patients with a clinical diagnosis of trigger finger grade 1-3 on the Quinnell grading scale and confirmed diagnosis by ultrasound. Exclusion Criteria: Quinnell's classification grade IV (contracture) Prior injection within 6 months Prior operation of the affected finger Presence of any contracture in the proximal interphalangeal or metacarpophalangeal joint, and History of diabetes, hypothyroidism, and Rheumatic or connective tissue disease Allergy to triamcinolone or hyaluronic acid Pregnancy Secondary triggering e.g. Trauma, infection Trigger finger symptoms duration >6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sahar S Khalil, SSR
Phone
00971557557453
Email
sskhalil@dha.gov.ae
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M Abdulla, Consultant
Phone
00971506584352
Email
mmabdulla@dha.gov.ae
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar S Khalil, SSR
Organizational Affiliation
Specialist Senior Registrar- Physical Medicine and rehabilitation Department- Dubai hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed M Abdulla, Consultant
Organizational Affiliation
Consultant and Head of Physical Medicine and rehabilitation Department- Dubai hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Dubai Hospital- Dubai Health Authority
City
Dubai
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
Phone
442195718
Ext
00971
Email
mmabdulla@dha.gov.ae
First Name & Middle Initial & Last Name & Degree
Sahar Khalil, SSR
First Name & Middle Initial & Last Name & Degree
Mohamed Abdulla

12. IPD Sharing Statement

Plan to Share IPD
No
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
background
PubMed Identifier
21545190
Citation
Callegari L, Spano E, Bini A, Valli F, Genovese E, Fugazzola C. Ultrasound-guided injection of a corticosteroid and hyaluronic acid: a potential new approach to the treatment of trigger finger. Drugs R D. 2011;11(2):137-45. doi: 10.2165/11591220-000000000-00000.
Results Reference
background
PubMed Identifier
24895610
Citation
Abate M, Schiavone C, Salini V. The use of hyaluronic acid after tendon surgery and in tendinopathies. Biomed Res Int. 2014;2014:783632. doi: 10.1155/2014/783632. Epub 2014 May 8.
Results Reference
background

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Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger

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