Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger

Sponsor
Dubai Health Authority (Other)
Overall Status
Recruiting
CT.gov ID
NCT04645303
Collaborator
(none)
100
1
2
6.9
14.5

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: hyaluronic acid (20 mg/2 mL)
  • Drug: Triamcinolone acetonide 10mg/ml
Early Phase 1

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Ultrasound-Guided Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger: Randomized Controlled Study
Actual Study Start Date :
Nov 6, 2020
Anticipated Primary Completion Date :
Apr 5, 2021
Anticipated Study Completion Date :
Jun 4, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hyaluronic acid

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)
A1-Pulley infiltration for trigger finger
Other Names:
  • Hyalgan 20 mg in 2 ML Prefilled Syringe
  • Active Comparator: Triamcinolone acetonide

    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
    A1-Pulley infiltration for trigger finger
    Other Names:
  • Kenalog 10 mg/ml
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Quinnell trigger finger grading system: [1 and 3 months post-injection]

      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

    1. Visual analogue scale (VAS) of pain [1 and 3 months post-injection]

      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).

    2. Frequency of tender trigger nodules [1 and 3 months post-injection]

      Identifying the presence of tender nodules at A1-pulley of the affected finger by palpation

    3. The Quick Disability of the Arm, Shoulder and Hand score [1 and 3 months post-injection]

      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.

    4. Changes in Grip strength [1 and 3 months post-injection]

      Measured by the dynamometer strength test (Jamar grip dynamometer)

    5. Patient satisfaction with therapy [1 and 3 months post-injection]

      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.

    6. Ultrasound evaluation of A1-Pulley [1 and 3 months post-injection]

      Detailed ultrasonography evaluation of A1-Pulley. Comparing the A1-Pulley ultrasonographic parameters over 3 months after injection (at the follow-up appointment)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dubai Hospital- Dubai Health Authority Dubai United Arab Emirates

    Sponsors and Collaborators

    • Dubai Health Authority

    Investigators

    • Principal Investigator: Sahar S Khalil, SSR, Specialist Senior Registrar- Physical Medicine and rehabilitation Department- Dubai hospital
    • Study Chair: Mohamed M Abdulla, Consultant, Consultant and Head of Physical Medicine and rehabilitation Department- Dubai hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sahar Said Khalil, Specialist Senior Registrar- Physical Medicine and Rehabilitation Department- Dubai Hospital- UAE( co-affiliation: Assistant Professor Rheumatology, physical Medicine and rehabilitation- Zagazig University- Egypt), Dubai Health Authority
    ClinicalTrials.gov Identifier:
    NCT04645303
    Other Study ID Numbers:
    • DSREC-12/2019_03
    First Posted:
    Nov 27, 2020
    Last Update Posted:
    Nov 27, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Sahar Said Khalil, Specialist Senior Registrar- Physical Medicine and Rehabilitation Department- Dubai Hospital- UAE( co-affiliation: Assistant Professor Rheumatology, physical Medicine and rehabilitation- Zagazig University- Egypt), Dubai Health Authority
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 27, 2020