Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger

Trigger Finger Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04645303
• Other study ID #: DSREC-12/2019_03
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 6, 2020
• Est. completion date: June 4, 2021

Study information

• Verified date: November 2020
• Source: Dubai Health Authority
• Contact: Sahar S Khalil, SSR
• Phone: 00971557557453
• Email: sskhalil[@]dha.gov.ae
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 4, 2021
• Est. primary completion date: April 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Trigger Finger
• Trigger Finger Disorder

Intervention

Drug:
• hyaluronic acid (20 mg/2 mL)
A1-Pulley infiltration for trigger finger
• Triamcinolone acetonide 10mg/ml
A1-Pulley infiltration for trigger finger

Locations

Country	Name	City	State
United Arab Emirates	Dubai Hospital- Dubai Health Authority	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
Dubai Health Authority

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (3)

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. Review. — View Citation

Callegari L, Spanò 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	1 and 3 months post-injection
Secondary	Frequency of tender trigger nodules	Identifying the presence of tender nodules at A1-pulley of the affected finger by palpation	1 and 3 months post-injection
Secondary	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.	1 and 3 months post-injection
Secondary	Changes in Grip strength	Measured by the dynamometer strength test (Jamar grip dynamometer)	1 and 3 months post-injection
Secondary	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.	1 and 3 months post-injection
Secondary	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)	1 and 3 months post-injection