Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger

November 25, 2020 updated by: Sahar Said Khalil, Dubai Health Authority

Ultrasound-Guided Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger: Randomized Controlled Study

The aim of the study is to compare the therapeutic effects of hyaluronic acid versus steroid injections in treating trigger fingers using ultrasound guidance

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Arab Emirates
      • Dubai, United Arab Emirates
        • Recruiting
        • Dubai Hospital- Dubai Health Authority
        • Contact:
        • Principal Investigator:
          • Sahar Khalil, SSR
        • Sub-Investigator:
          • Mohamed Abdulla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quinnell trigger finger grading system:
Time Frame: 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.
1 and 3 months post-injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale (VAS) of pain
Time Frame: 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).
1 and 3 months post-injection
Frequency of tender trigger nodules
Time Frame: 1 and 3 months post-injection
Identifying the presence of tender nodules at A1-pulley of the affected finger by palpation
1 and 3 months post-injection
The Quick Disability of the Arm, Shoulder and Hand score
Time Frame: 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.
1 and 3 months post-injection
Changes in Grip strength
Time Frame: 1 and 3 months post-injection
Measured by the dynamometer strength test (Jamar grip dynamometer)
1 and 3 months post-injection
Patient satisfaction with therapy
Time Frame: 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.
1 and 3 months post-injection
Ultrasound evaluation of A1-Pulley
Time Frame: 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)
1 and 3 months post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2020

Primary Completion (Anticipated)

April 5, 2021

Study Completion (Anticipated)

June 4, 2021

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 25, 2020

First Posted (Actual)

November 27, 2020

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSREC-12/2019_03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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