Effect of Ultrasound-guided Corticosteroid Injection Versus Palpation-guided Injection for de Quervain's Disease: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- QuickDASH
研究概览
简要总结
The purposes of this study are to compare the effectiveness and side effects of US-guided and palpation-guided corticosteroid injections for de Quervain's disease.
详细描述
De Quervain's disease is a common clinical disorder, characterized by pain at radial side of the wrist. It often interferes wrist and thumb movement, and may affect activity of daily life. It is caused by overuse and impaired gliding of the abductor pollicis longus (APL) and extensor policis brevis (EPB) tendons at the styloid process of the radius. It is associated with postpartum baby care, or jobs or hobbies that involve repetitive hand and wrist motions. The most effective treatment is corticosteroid injection into the tendon sheath of the conjoined tendons of APL and EPB. Over the past few years because of advancement of sonography in the musculoskeletal system, ultrasound (US)-guided intra-sheath injection has become popular, and it has been proved to improve the accuracy of placement of needle tip in the tendon sheath, however, studies comparing the effect and side effects of US-guided corticosteroid injection with palpation-guided injection for de Quervain's disease have never been reported before. The purposes of this study are to compare the effectiveness and side effects of US-guided and palpation-guided corticosteroid injections for de Quervain's disease.
The investigators plan to recruit 70 patients with de Quervain's disease, half of them will be randomly assigned into US-guided injection group, and the other half into the palpation-guided injection group. Each subject will receive one shot of injection and each subject will expect to fill in the evaluation form at baseline, and at 1 week, 3 months, and 6 months after the injection. Statistics will be performed after completing the patients' treatment and evaluations.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain and tenderness at the radial side of the wrist.
- •Positive Finkelstein sign, or pain on resistive maximal isometric contraction of extension and/or abduction of the affected thumb.
- •pain intensity on a 10-point visual analog scale (VAS) for pain to ≧ 3 on active thumb abduction or extension.
- •Patient agrees to receive either palpation-guided or US-guided local corticosteroid injection.
- •Age ≧ 20 years old.
排除标准
- •Presence of an absolute contraindication for corticosteroids or local anesthetics injection.
- •During pregnancy.
- •Severe systemic diseases with poor control.
- •Prior treatment with corticosteroid injection and/or surgery at the same anatomical location in the last 6 months.
- •Being unable to fill-in the follow-up forms.
结局指标
主要结局
QuickDASH
时间窗: 1 week after injection
QuickDASH is a self-report questionnaire comprising 11 items that focuses on symptoms and the ability to perform certain upper extremity activities on a five-point Likert-type scale. The scores range from 0 (the best) to 100 (the worst). The reliability of QuickDASH was 0.93, and the validity based on response of full-length DASH was 0.96.18
次要结局
- VAS pain(beginning of the treatment and at 1 week ,3 months and 6 months after the beginning of the treatment.)
- Direct treatment response(beginning of the treatment and at 1 week ,3 months and 6 months after the beginning of the treatment.)
研究者
Lin-Fen Hsieh
Principal Investigator
Shin Kong Wu Ho-Su Memorial Hospital