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临床试验/NCT03524378
NCT03524378已完成不适用

Chronic Low Back Pain in Seafood Workers: a Pilot Intervention Study to Identify Modifiable Work and Movement Solutions

University of Florida4 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2018年6月1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
37
试验地点
4
主要终点
Pain rating scales

研究概览

简要总结

Chronic low back pain has been identified as a major problem for seafood and agricultural workers, and is known to affect worker health and productivity. The aims of this study are to: 1) identify modifiable, sector-specific, work and movement solutions with the potential to reduce the burden or severity of chronic lower back pain in clam workers and 2) determine the extent that participants adopt identified solution(s), and the impact on functional difficulty and low back pain.

详细描述

This pilot/feasibility pre-post intervention study will use a participatory ergonomic approach without a control group or randomization. The participatory approach will foster capacity building by creating support within the workplace communities and by involving seafood workers in developing context specific solutions for their own work practice, increasing the potential for adoption and success.

Phase 1: Specific Aim 1: Identify modifiable, sector-specific work and movement solutions with that can reduce the burden or severity of chronic lower back pain

  1. Development of rapid prototype video clips: clam workers will be videotaped performing typical work tasks during daily operations on the boat, as well as transporting, sorting and packing clams will be analyzed. Key movements and positions such as lifting, prolonged static flexed positions that may be contributing to repetitive stress in the low back region will be categorized. Short clips will be edited to create examples of movements and positions for each category potentially contributing to low back pain.
  2. Prioritization of specific tasks and relevant solutions by key leaders: Up to 10 participants with a history of chronic low back pain for more than 3 months will be recruited by the Cedar Key Aquaculture Association for the initial pilot testing of research methods. Once participants have provided informed consent, they will complete a general demographic survey, functional disability and pain questionnaire and surveys to measure co-variates that include pain fear and anxiety, self-efficacy and coping questions.

Focus groups will be held in the participant's work settings with consented individuals from the same work teams to ensure application within a specific context and promote discussion directed towards the best outcomes. Participants will discuss major tasks and factors contributing to their low back pain using the video clips to target discussions and their opinions of options that would help alleviate or prevent pain. Only clips from the relevant teams will be used for each focus group. The focus groups will be recorded and transcribed for analysis and as a record of discussion.

Basic principles of ergonomic adaptation and movement modification for repetitive work activities on and off the boat and lifting will be introduced using demonstrations and discussion in a small group format. Participants will discuss other possible solutions. Self-management including movement strategies and pain relief techniques will be introduced and demonstrated by the principal investigator. The educational session will be videotaped to ensure all relevant discussions are considered during the development of interventions and to assist with reliability of intervention delivery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • History of chronic low back pain
  • Employed full time in clam harvesting/processing

排除标准

  • History of spinal surgery in past 3 years
  • Recent hospitalization in the past year for any condition
  • Subjects currently seeking disability

结局指标

主要结局

Pain rating scales

时间窗: Change from baseline average measured over 4 weeks, after 4 and 8 weeks

Pain ratings for each of the items identified in the patient specific functional scale (best, worst and average ratings) over the past day with 0/100 reflecting no pain, 100/100 most excruciating pain possible

Patient Specific Functional Scale

时间窗: Change from baseline average measured over 4 weeks, after 4 and 8 weeks

3 work items regarded as the most painful or difficult activities will selected by each participant and rated on a 0-100 scale with inability to complete a task rated as 0/100 and ability to perform the activity without any difficulty due to low back pain as a 100/100. Participants will also report the amount of time that they are able to complete the task without stopping or changing tasks due to low back pain for each activity.

次要结局

  • Pain coping questions(Baseline, Day 1, 4 weeks, 8 weeks)
  • Short form pain anxiety symptom scale(Baseline, Day 1, 4 weeks, 8 weeks)
  • Fear avoidance single item question(Baseline, Day 1, 4 weeks, 8 weeks)
  • Pain self-efficacy questions(Baseline, Day 1, 4 weeks, 8 weeks)
  • Oswestry Disability Index for low back pain(Baseline, at 4 weeks and after intervention at 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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