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临床试验/NCT05165875
NCT05165875Unknown不适用

Splint Versus Steroid Injection for DeQuervain's Tenosynovitis: A Randomized Trial

National University Hospital, Singapore0 个研究点目标入组 100 人开始时间: 2022年6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
入组人数
100
主要终点
Quick Disability of Arm, Shoulder, Hand (QuickDASH)

研究概览

简要总结

The primary aim is to compare the effectiveness of splinting versus steroid injection in improving the DASH scores in participants diagnosed with De Quervain's tenosynovitis over a period of 6 months.

详细描述

The primary hypothesis is that steroid injection into the first dorsal compartment is more effective compared with splinting at 3 months.

The secondary hypothesis is that steroid injection yields better clinical outcomes compared with splinting at 1 month, 3 months and 6 months.

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
None

入排标准

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

入选标准

  • Confirmed diagnosis of de Quervain's tenosynovitis based on the de Quervain's screening tool (DQST) with scores ≥ 5 (refer to table 1)
  • No prior treatment
  • Above 21 years of age

排除标准

  • Allergy to steroid (triamcinolone acetate) or local anaesthetic (lignocaine)
  • History of work related trauma

研究组 & 干预措施

Randomized: Steroid injection

Other

1ml injection of a mixture of 0.5ml triamcinolone acetonide (50mg/5ml) and 0.5ml 1% lignoacaine is given intra-thecally into the first extensor compartment.

干预措施: Hydrocortisone-Lidocaine (Drug)

Randomized: Splint

Other

a long thumb spica thermoplastic splint (wrist neutral, 30º CMCJ flexion, 30º thumb abduction, IPJ free) will be customized and intermittent active range of motion exercises will be taught for 4 weeks

干预措施: Splint (Other)

结局指标

主要结局

Quick Disability of Arm, Shoulder, Hand (QuickDASH)

时间窗: 6 months

Our co- primary outcome would be QuickDash. QuickDash is a disability score we use for the upper limb where the higher score indicates greater disability and severity. We would expect a decrease in QuickDash scores following a success in the treatment measure. The resultant score is reported on a scale of 0 to 100, where 0 represents no disability and 100 represents total disability

Patients who have recovered from De Quervain's Tenosynovitis

时间窗: 6 months

The other primary outcomes would be the number of patients who have completely recovered from De Quervain's tenosynovitis. This will be determined by the global improvement the patient feels that will be ranked on a 7 point Likert scale (1: very much worse, 2: much worse, 3:slightly worse, 4:no change, 5:slightly better, 6:much better, 7:completely resolved).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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Splint Versus Steroid Randomized Trial | 临床试验