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临床试验/NCT01950793
NCT01950793已完成不适用

Steroid Versus Hyaluronic Acid Ultrasound-guided Injection for Trigger Finger: A Comparative Study of Outcomes

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Quinnell classification

研究概览

简要总结

The study is to compare the effect between steroid injection and Hyaluronic acid in treatment trigger finger. Using sonoguided injection technique achieves more accurate injection location and therapeutic effect. We hypothesize hyaluronic acid has both lubricant and anti-inflammation effect in treatment of trigger finger, and can provide better outcome and lower adverse effect than steroid injection.

详细描述

This is a prospective, randomized, double-blinded controlled study. Patients with the diagnosis of trigger finger will be recruited and enrolled from Taipei Veteran General Hospital PM&R outpatient clinic. Subjects will be randomized into two groups; hyaluronic acid and triamcinolone acetonide injections, both via ultrasound-guided with one injection only.We hypothesize that through the anti-inflammatory property of the hyaluronate acid, the treatment effects will be as effective as the traditionally used steroid injections with equal or even lower recurrence rate for treatment of trigger finger. We expect that injections of hyaluronate into tendon sheath could become a new treatment option for trigger finger.

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with trigger digits and patients
  • without previous treatment of the trigger digit

排除标准

  • patients with prior treatment of the trigger digit (eg, splinting, injection, or therapy),
  • patients less than
  • 20 years old,
  • patients with allergy or contraindication to hyaluronic acid,
  • patients with trigger digits due to rheumatoid arthritis,
  • and patients with infection at the site of injection.

研究组 & 干预措施

steroid

Active Comparator

used ultrasound-guided inject 1c.c triamcinolone acetonide 10mg/mL (Shincort®, YSP, Taiwan)into the sheath of the flexor tendons, penetrated to the A1 pulley.

One injection only

干预措施: triamcinolone acetonide (Drug)

Hyaluronic acid

Experimental

used ultrasound-guided inject 1c.c Hyaluronic acid (Artz®, Seikagaku, Japan)into the sheath of the flexor tendons, penetrated to the A1 pulley.

One injection only

干预措施: Hyaluronic Acid (Drug)

结局指标

主要结局

Quinnell classification

时间窗: Pre-injection; 3-weeks and 3-months post-injections

he Quinnell system grades trigger fingers as: 0 - normal movement 1. - uneven movement 2. - locking can be corrected with active motion 3. - locking corrected with passive motion 4. - unable to correct deformity

次要结局

  • visual analog scale(Pre-injection; 3-weeks and 3-months post-injections)
  • hand functional evaluation(Pre-injection; 3-weeks and 3-months post-injections)
  • total active motion (TAM)(Pre-injection; 3-weeks and 3-months post-injections)
  • grip strength(Pre-injection; 3-weeks and 3-months post-injections)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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