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临床试验/NCT02708693
NCT02708693已完成不适用

Efficacy of Combined Ultrasound Guided Steroid Injection and Splinting in Patients With Carpal Tunnel Syndrome

Taipei Veterans General Hospital, Taiwan0 个研究点目标入组 52 人开始时间: 2013年4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
52
主要终点
Change from Baseline in the scores on the Boston Carpal Tunnel Questionnaire (BQ).

研究概览

简要总结

To compare the effectiveness of ultrasound guided-steroid injection plus splinting to that of steroid injection alone using clinical and electrophysiological parameters in patients with carpal tunnel syndrome

详细描述

This is a prospective, single-blinded randomized controlled study. Patient with CTS were randomly assigned to group receiving ultrasound guided steroid injection and group receiving ultrasound guided corticosteroid injection and splinting. The steroid injection was using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine). The inclusion criteria included an age of more than 18 years and typical signs of CTS according to American Academy of Neurology criteria lasting for at least 3 months. The diagnosis of CTS was confirmed by electrophysiological tests.The exclusion criteria included the following: presence of thenar atrophy; existence of disorders such as hypothyroidism, diabetes mellitus, chronic renal failure, or rheumatoid arthritis; any accompanying orthopedic or neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome; prior steroid injection into the affected carpal tunnel or carpal tunnel surgery; history of distal radius fracture; pregnancy or lactation; regular use of systemic NSAIDs or corticosteroids; and known allergy to corticosteroids and local anesthetics.

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
Single (Participant)

入排标准

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

入选标准

  • clinical diagnosis of CTS
  • The diagnosis of CTS was confirmed by electrophysiological tests.

排除标准

  • presence of thenar atrophy
  • existence of disorders such as hypothyroidism, diabetes mellitus, chronic renal failure, or rheumatoid arthritis; any accompanying orthopedic or neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome
  • prior steroid injection into the affected carpal tunnel or carpal tunnel surgery
  • history of distal radius fracture
  • pregnancy or lactation
  • regular use of systemic NSAIDs or corticosteroids
  • known allergy to corticosteroids and local anesthetics.

研究组 & 干预措施

experimental: steroid injection and splinting

Experimental

ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine) and a customized volar thermoplastic wrist splint

干预措施: Triamcinolone Acetonide (Drug)

experimental: steroid injection and splinting

Experimental

ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine) and a customized volar thermoplastic wrist splint

干预措施: thermoplastic wrist splint (Device)

experimental: steroid injection and splinting

Experimental

ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine) and a customized volar thermoplastic wrist splint

干预措施: lidocaine hydrochloride (Drug)

steroid injection

Active Comparator

ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)

干预措施: Triamcinolone Acetonide (Drug)

steroid injection

Active Comparator

ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort) mixed with 1 ml of 2% lidocaine hydrochloride (Xylocaine)

干预措施: lidocaine hydrochloride (Drug)

结局指标

主要结局

Change from Baseline in the scores on the Boston Carpal Tunnel Questionnaire (BQ).

时间窗: at 2, 6, 12 weeks

The BQ was interviewed-administered to assess the severity of symptoms and functional status.

次要结局

  • Change from Baseline in Median nerve distal motor latency(at 2, 6, 12 weeks)
  • Change from Baseline in sensory nerve conduction velocity(at 2, 6, 12 weeks)
  • Change from Baseline in compound muscle action potential amplitude (CMAP)(at 2, 6, 12 weeks)
  • Change from Baseline in sensory nerve action potential amplitudes.(at 2, 6, 12 weeks)
  • Change from Baseline in self-reported pain intensity(at 2, 6, 12 weeks)
  • change from Baseline in Cross sectional area(at 2, 6, 12 weeks)
  • change from Baseline in flattening ratio(at 2, 6, 12 weeks)

研究者

申办方类型
Other Gov
责任方
Sponsor

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