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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04645303
Other study ID # DSREC-12/2019_03
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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