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临床试验/NCT01562418
NCT01562418Unknown不适用

Multi Dimensional System for Evaluating a Preventive Program for Upper Extremity Disorders Among Computer Operators

Medical Corps, Israel Defense Force1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2009年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
108
试验地点
1
主要终点
Musculoskeletal disorders measurement (MSD score)

研究概览

简要总结

Computer settings points to a number of risk factors which may induce the development of Work related MSD (WRMSD). In light of the expanded use of computers and the increased occurrence of Upper Extremity (UE) WRMSD among computer operators various intervention programs have been developed and tested. Nevertheless, many of these programs do not meet the criteria of quality and level of evidence.

The main objective of this study is to use simultaneously a three dimensional (3D) kinematic analysis system, surface electromyography (SEMG) and fingertip force measurement system (Flexiforce) while typing, to test the efficacy of primary and secondary preventive intervention programs aimed at reducing MSD among computer operators.

Work hypothesis: Significant score differences will be found on the evaluation parameters between the research group which underwent ergonomic training with biofeedback, the group without feedback, and the control group.The evaluated parameters will correlate with the appearance of MSD symptoms and pain and will affect level of function.

The study will include 66 participants, programmers and computer engineers. The participants will be assigned randomly to one of three groups: 1) participants will receive ergonomic training with biofeedback; 2) participants will receive ergonomic training without biofeedback; and 3) control group, without intervention. Each group will consist of 22 participants.

Treatment efficacy will be tested both at work and in the motion lab. In the lab, 3D kinematic measurements and fingertip forces relevant to typing while entering a standard text will be measured. At the work site, anthropometric and measurements, work station measurements, posture observation and questionnaires about, psychosocial status, function and pain level will be filled The preventive program will be performed at the workstation after the preliminary data collection phase. The program will consist of one group meeting at the workplace for all employees participating in the study, and individual instruction at the workstation, including 3-6 meetings for the two research groups. Data will be collected before and after the intervention program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •subjects working more than four hours per day in front of a computer and are right-hand dominant.
  • •Healthy or suffering from diagnoses of UE-MSD. (e.g. Rotator cuff syndrome , Lateral epicondylitis, Cubital tunnel syndrome, Carpal tunnel syndrome, Flexor-extensor peri-tendinitis or teno-synovitis of the forearm-wrist region, De Quervain's disease and Nonspecific MSD

排除标准

  • •Participants suffering from orthopedic injury or neurological deficit (with the exception of the diagnosis mentioned above).
  • •Medical conditions that cause swelling of the joints or hand numbness (pregnancy, diabetes, heart condition, arthritis).

研究组 & 干预措施

Ergonomic consulting

Experimental

Ergonomic consulting without biofeedback

干预措施: Standard ergonomic intervention (Behavioral)

Ergonomic consulting with biofeedback

Experimental

Ergonomic intervention with biofeedback

干预措施: Ergonomic intervention (Behavioral)

general instructions

No Intervention

general instructions with no intervention

干预措施: control group (Behavioral)

结局指标

主要结局

Musculoskeletal disorders measurement (MSD score)

时间窗: Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.

The MSD score of the whole body will be collected out of a self administrated questionnaire in the first meeting before intervention and in the last meeting. the score indicates the number of painful body regions that were harmful in the last week before answering the Questionnaire. Negative differences between post and pre intervention will indicate improvement in pain.

次要结局

  • Rapid Upper Limb Assessment (RULA)score(Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one)
  • Kinematic Data [range of motion ( R.O.M) and angular velocity]measured by 3D motion analysis system.(Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.)
  • Muscle activity(Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.)
  • Psychosocial job characteristics assessment (DCSQ)(Minimum 10 weeks and maximum 15 weeks between the first measurement and the last one.)

研究者

发起方
Medical Corps, Israel Defense Force
申办方类型
Other
责任方
Sponsor

研究点 (1)

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