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临床试验/NCT02313324
NCT02313324已完成不适用

The Effects of Extracorporeal Shock Wave Therapy in Patients With Coccydynia: A Randomized Controlled Trial

Kaohsiung Medical University Chung-Ho Memorial Hospital0 个研究点目标入组 42 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
主要终点
Change from pre-enrollment in Visual analog scale (VAS) at 5th and 8th week after first intervention

研究概览

简要总结

The purpose of this study is to evaluate the effects of extracorporeal shock wave therapy (ESWT) on the outcomes of coccydynia.

详细描述

Coccydynia is pain in the coccygeal region, and usually treated conservatively. Extracorporeal shock wave therapy (ESWT) was incorporated as non-invasive treatment of many musculoskeletal conditions. However, the effects of ESWT on coccydynia are less discussed. The purpose of this study is to evaluate the effects of ESWT on the outcomes of coccydynia. Patients were allocated to ESWT (n=20) or physical modality (SIT) group (n=21) randomly, and received total treatment duration of 4 weeks. The visual analog scale (VAS), Oswestry disability index (ODI), and self-reported satisfaction score were used to assess treatment effects. The VAS and ODI scores were significantly decreased after treatment in both groups, and the decrease in the VAS score was significantly greater in the ESWT group. The mean proportional changes in the ODI scores were greater in the ESWT group than in the SIT group, but the between-group difference was not statistically significant. The patients in the ESWT group had significantly higher subjective satisfaction scores than SIT group. The investigators concluded that ESWT is more effective and satisfactory in improving discomfort and disability caused by coccydynia than the use of physical modalities. Thus, ESWT is recommended as an optimal treatment option for patients with coccydynia.

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 (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 83 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First-time diagnosed with coccydynia
  • History of direct traumatic events to the buttocks, such as falls or slipping

排除标准

  • Tumors of the cauda equina
  • Pelvic surgery
  • Herniation of the lumbosacral disc
  • Internal procidentia
  • Genitourinary or gastrointestinal complaints
  • Psychogenic factors

结局指标

主要结局

Change from pre-enrollment in Visual analog scale (VAS) at 5th and 8th week after first intervention

时间窗: pre-enrollment, 5th and 8th week after first intervention

a scale from 0 through 100 (0 for no pain and 100 for the worst pain)

次要结局

  • Change from pre-enrollment in The Oswestry disability index (ODI, in Chinese) at 5th and 8th week after first intervention(pre-enrollment, 5th and 8th week after first intervention)
  • Change from pre-enrollment in Self-reported satisfaction scales at 8th week after first intervention(8th week after first intervention)

研究者

申办方类型
Other
责任方
Sponsor

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