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临床试验/NCT04138355
NCT04138355已完成不适用

The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns : a Randomized Controlled Study

Hangang Sacred Heart Hospital2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
transepithelial water loss

研究概览

简要总结

No study has investigated the effect of extracorporeal shock wave therapy (ESWT) on hand function and hypertrophic scar characteristics. To investigate ESWT effects on burned hands, the investigators compare the results of ESWT combined with manual therapy group to the results of matched conventional(CON) rehabilitation combined with manual therapy group.

详细描述

Hands are the most frequent injury sites caused by burn, and appropriate rehabilitation is essential to ensure that good functional recovery is achieved. In burn patients, the wound healing process may lead to a fibrotic hypertrophic scar, which is raised, red, inflexible and responsible functional and cosmetic impairments.

This randomized, controlled trial involved 40 patients with burns and dominant right-hand function impairment. Patients were randomized into a ESWT or a CON group. Each intervention was applied to the affected hand for 4 weeks once per week. Hand function was evaluated using the Jebsen-Taylor hand function test (JTT), grasp and pinch power test, and Michigan Hand Outcomes Questionnaire (MHQ). These assessments were evaluated pre-intervention and 4 weeks post-intervention.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn to their hands
  • less than 6 months since the onset of the burn injury

排除标准

  • fourth-degree burns(involving muscles, tendons, and bone injuries)\
  • musculoskeletal diseases(fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) in the burned hands
  • neurological diseases(such as peripheral nerve disorders)
  • preexisting physical and psychologic disability (severe aphasia and cognitive impairment that could influence the intervention)
  • severe pain impeding hand rehabilitation

结局指标

主要结局

transepithelial water loss

时间窗: 4 weeks

the degree of water evaporation

elasticity

时间窗: 4 weeks

The numeric values (mm) of the skin's distortion is presented as the elasticity.

thickness

时间窗: 4 weeks

scar thickness(cm)

sebum

时间窗: 4 weeks

the severity of greese, the higher values indicating a more greese(mg/cm2)

melanin and erythema

时间窗: 4 weeks

measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin(AU)

次要结局

  • grip strength(4 weeks)
  • Jebsen-Taylor hand function test(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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