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临床试验/NCT04645303
NCT04645303Unknown早期 1 期

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

Dubai Health Authority1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年11月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
100
试验地点
1
主要终点
Change in Quinnell trigger finger grading system:

研究概览

简要总结

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

详细描述

A prospective randomized controlled study designed to compare the outcomes of injecting patients with trigger finger with hyaluronic acid versus corticosteroid under ultrasound guidance

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: hyaluronic acid (20 mg/2 mL) (Drug)

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.

干预措施: Triamcinolone acetonide 10mg/ml (Drug)

结局指标

主要结局

Change in Quinnell trigger finger grading system:

时间窗: 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.

次要结局

  • Changes in Grip strength(1 and 3 months post-injection)
  • The Quick Disability of the Arm, Shoulder and Hand score(1 and 3 months post-injection)
  • Visual analogue scale (VAS) of pain(1 and 3 months post-injection)
  • Frequency of tender trigger nodules(1 and 3 months post-injection)
  • Patient satisfaction with therapy(1 and 3 months post-injection)
  • Ultrasound evaluation of A1-Pulley(1 and 3 months post-injection)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

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

研究点 (1)

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