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临床试验/NCT01332760
NCT01332760已完成不适用

Effect of Tool Design on Hand Pain in Dental Practitioners

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2009年4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
110
试验地点
2
主要终点
change from baseline in right shoulder pain score at 4 months

研究概览

简要总结

Dentists and dental hygienists experience elevated rates of musculoskeletal disorders, such as carpal tunnel syndrome and tendonitis, primarily due to the high pinch force required for dental scaling. There is evidence that a lighter and larger diameter tool can significantly reduce the pinch force. This randomized controlled study will determine if dentists or dental hygienists who use such a tool report less hand and arm pain compared to those who continue to use the conventional tool design.

详细描述

This is a randomized controlled trial to evaluate the effects of a new dental tool handle design on hand and arm symptoms among dentists and dental hygienists who perform dental scaling. This will be a 4 month intervention in the practitioner's workplace. The study may identify a tool handle design that reduces the risk for developing upper extremity occupational musculoskeletal disorders (e.g., carpal tunnel syndrome) among dentists and dental hygienists.

The specific aims of the project are to determine whether hand/wrist, forearm/elbow and shoulder symptoms (e.g., pain, fatigue, paresthesias) and hand function are less severe among dentists and dental hygienists who use a new dental tool in comparison to those who use a more conventional tool for performing scaling. One hundred twenty (120) subjects will be randomized to use one of 2 handle designs for a 4 month period and during this time will perform their usual dental scaling work with the new tools. The effects on outcome measures will be adjusted for potential covariates (e.g., age, gender, hours scaling per week, etc.). The primary null hypothesis is: there is no difference in change in pain severity between subjects who use a new tool in comparison to those who use a conventional tool.

RESEARCH DESIGN AND METHODS

In this study, 120 participating dentists and dental hygienists will be randomized to receive one of 2 scaling tools and will use the tools for 3 months while performing their usual dental scaling work. Randomization will be at the level of the clinic to avoid participant contamination. Participants will complete a weekly questionnaire to assess symptom severity. The data analysis will use an intention-to-treat approach and will control for important covariates.

Interventions Based on the pilot data, the investigators have selected 2 tool handle designs that are similar to conventional tools but have features that exploit the differences identified in our preliminary data. The dependent measures of pinch force and muscle activity were most sensitive to diameter, followed by weight, followed by shape. The tool characteristics selected for this proposal are based on the data from the laboratory studies presented in the Preliminary Studies section and the Appendix (Dong et al., JADA, 2006; Dong et al., Appl Ergo, 2007). The tool parameters were selected to provide the greatest difference in peak pinch force, yet be as close as possible to the look and feel of a conventional instrument. Half of the participants will be provided with Tool 1 and half with Tool 2. Tool 1 is the closest to a conventional tool in diameter and weight while Tool 2 has a larger diameter and is lighter. The differences and similarities between Tools 1 and 2 are listed below.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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

  • dentists and dental hygienists from the San Francisco Bay Area
  • dental practitioners who perform more than 10 hours of dental hygiene work per week
  • dental practitioners who have been performing dental hygiene work for more than 1 year

排除标准

  • not currently under a physician's care for treatment of an upper extremity disorder

结局指标

主要结局

change from baseline in right shoulder pain score at 4 months

时间窗: 4 months after intervention

peak pain assessed on 0-10 scale using end of week questionnaire

Change from baseline in right elbow pain at 4 months

时间窗: 4 months after intervention

peak pain assessed on 0-10 scale using end of week questionnaire

change from baseline in right wrist pain at 4 months

时间窗: 4 months after intervention

peak pain assessed on 0-10 scale using end of week questionnaire

次要结局

  • change in pain medication usage(pre-intervention compared to post intervention)
  • change in nights per week waken from sleep due to finger numbness(pre-intervention compared to post intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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