Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger

NCT04645303 | Unknown Early Phase 1 DMC FDA Drug

• 1 other identifier: DSREC-12/2019_03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Trigger Finger

Keywords

Trigger finger; Hyaluronic Acid; Corticosteroid; Ultrasound-guided injection

Outcome Measures

Primary Outcomes (1)

• 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.

  1 and 3 months post-injection

Secondary Outcomes (6)

• Visual analogue scale (VAS) of pain

  1 and 3 months post-injection

• Frequency of tender trigger nodules

  1 and 3 months post-injection

• The Quick Disability of the Arm, Shoulder and Hand score

  1 and 3 months post-injection

• Changes in Grip strength

  1 and 3 months post-injection

• Patient satisfaction with therapy

  1 and 3 months post-injection

Study Arms (2)

Hyaluronic acid

EXPERIMENTAL

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.

Drug: hyaluronic acid (20 mg/2 mL)

Triamcinolone acetonide

ACTIVE COMPARATOR

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.

Drug: Triamcinolone acetonide 10mg/ml

Interventions

hyaluronic acid (20 mg/2 mL) DRUG

A1-Pulley infiltration for trigger finger

Also known as: Hyalgan 20 mg in 2 ML Prefilled Syringe

Hyaluronic acid

Triamcinolone acetonide 10mg/ml DRUG

A1-Pulley infiltration for trigger finger

Also known as: Kenalog 10 mg/ml

Triamcinolone acetonide

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dubai Health Authority: lead

Study Sites (1)

Dubai Hospital- Dubai Health Authority

Dubai, United Arab Emirates

RECRUITING

Related Publications (3)

• 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: 26340807 BACKGROUND

• 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.

  PMID: 21545190 BACKGROUND

• 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.

  PMID: 24895610 BACKGROUND

MeSH Terms

Conditions

Trigger Finger Disorder

Interventions

Hyaluronic Acid; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Sahar S Khalil, SSR

  Specialist Senior Registrar- Physical Medicine and rehabilitation Department- Dubai hospital

  PRINCIPAL INVESTIGATOR

• Mohamed M Abdulla, Consultant

  Consultant and Head of Physical Medicine and rehabilitation Department- Dubai hospital

  STUDY CHAIR

Central Study Contacts

Sahar S Khalil, SSR

CONTACT

00971557557453; sskhalil@dha.gov.ae

Mohamed M Abdulla, Consultant

CONTACT

00971506584352; mmabdulla@dha.gov.ae

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Senior Registrar- Physical Medicine and Rehabilitation Department- Dubai Hospital- UAE( co-affiliation: Assistant Professor Rheumatology, physical Medicine and rehabilitation- Zagazig University- Egypt)

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 27, 2020
• Study Start: November 6, 2020
• Primary Completion: April 5, 2021
• Study Completion: June 4, 2021
• Last Updated: November 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)