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临床试验/NCT03014128
NCT03014128已完成不适用

Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics

District Hospital, Tuttlingen1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
DASH (Disabilities of the Arm, Shoulder and Hand) Score (questionnaire)

研究概览

简要总结

Work-related upper extremity musculoskeletal disorders (WRUEMSDs) have shown to be related to many occupational situations and specific industries. However, there is conflicting information about monotonous and repetitive activities. In this context, the profession of surgical device mechanics has not been analyzed so far.

The objective of this study is to examine surgical device mechanics at different workplaces with varying work contents and to compare them with a control group without the repetitive workload exposition as described above. The headquarters and main production site of Aesculap are located in Tuttlingen/Germany. Aesculap is the world leading manufacturer of surgical devices.

After statistical power analysis, the investigators plan to randomize and include a total of 90 voluntary test persons in 3 groups (30 persons each). The study will include standardized questionnaires and a physical examination as well as an industry test (Purdue Pegboard Test).

Primary and secondary endpoints were defined to show if significant difference between surgical device mechanics and a control group is present.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 years of age
  • work ability without absence > 2 weeks within the last 3 months
  • >5 years on workplace or similar workplace when in group of surgical device mechanics

排除标准

  • spinal syndrome in history
  • chronic shoulder pain in history
  • congenital malformation of the upper extremity/hand
  • rheumatoid arthritis or fibromyalgia in history
  • actual hand therapy as conservative therapy or therapy after operation due to upper extremity musculoskeletal pathology
  • previous operation(s) due to nerve entrapment syndrome or chronic musculoskeletal pathology of the upper extremity

结局指标

主要结局

DASH (Disabilities of the Arm, Shoulder and Hand) Score (questionnaire)

时间窗: 6 months

Validated questionnaire for upper extremity assessment (link in the reference section)

次要结局

  • Nerve entrapment syndromes(6 months)
  • Carpal tunnel syndrome(6 months)
  • Purdue Pegboard Test(6 months)
  • Range of wrist motion(6 months)
  • Tennis elbow (lateral epicondylitis)(6 months)
  • Grip force of the hand(6 months)
  • Stenosing tenosynovitis(6 months)
  • De Quervain tenosynovitis(6 months)
  • Finger sensibility(6 months)

研究者

发起方
District Hospital, Tuttlingen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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