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临床试验/NCT06864650
NCT06864650已完成不适用

Effectiveness of Ergonomic Training and Exercise in Automotive Factory Workers With Nonspecific Chronic Low Back Pain: a Randomized Controlled Trial

Uskudar University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年3月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
2
主要终点
Oswestry Low Back Pain Disability Questionnaire

研究概览

简要总结

This study compares the effectiveness of ergonomic training and exercise in automotive factory workers with chronic low back pain of unknown cause.

详细描述

The study was planned as a randomized controlled study. Workers between the ages of 18-60 who have back pain and work in an automotive factory in Galway, Ireland will be included in the study. Participants will be divided into two groups. The factory workers included in the study will be divided into a study group and a control group using a simple random method. Randomization will be done using the sealed envelope method. The study group will be given stretching and strengthening exercises along with ergonomics training. The control group will be given only ergonomics training. The exercises they will do and the ergonomics training will be explained to the participants individually and supported with a brochure. The participants will be asked to do the given exercises 3 days a week and continue for 12 weeks. The given exercises will be followed up with an exercise follow-up chart. In order to collect data on the sociodemographic characteristics of the participants, a personal information form will be prepared by the researcher and the participants will be asked to fill it out. In order to collect data from the participants; Visual Analog Scale will be used to collect information about pain, International Physical Activity Questionnaire to collect information about physical activity levels, Pittsburgh Sleep Quality Questionnaire to determine sleep quality, Oswestry Low Back Pain Scale for functionality assessment, Manual Muscle Testing to determine muscle strength. These questionnaires will be repeated before starting the study and at the end of the study. The data to be obtained will be evaluated using SPSS 24 package program.

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
Single (Outcomes Assessor)

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

  • •Being between 18-60 years old
  • •Having worked in the same factory for at least 2 years
  • •Working full time
  • •Having complained of back pain for at least 3 months
  • •visual analog scale>4, pain 4 and above on visual analog scale

排除标准

  • •Being under 18 years old or over 60 years old
  • •Having worked for less than 2 years
  • •Working part time
  • •Having complained of back pain for less than 3 months
  • •visual analog scale Presence of psychological problems
  • •Using sleeping pills
  • •Having undergone surgical intervention in the last 6 months

研究组 & 干预措施

Ergonomics training

Active Comparator

group without any intervention

干预措施: Ergonomics training (Other)

Ergonomics training +exercise program

Experimental

The group that followed the 12-week exercise program

干预措施: Ergonomics training (Other)

Ergonomics training +exercise program

Experimental

The group that followed the 12-week exercise program

干预措施: exercise program (Other)

结局指标

主要结局

Oswestry Low Back Pain Disability Questionnaire

时间窗: 14 weeks

It was developed to measure the functionality of individuals. The scale determines functional disability for activities such as sitting, walking, personal care, lifting, social life, travel, and sleep. There are 10 questions in this scale. Each question has 6 options. Participants are asked to choose the definition that best describes their situation from these options. A score of 0-5 is assigned for each of the sentences, and the highest possible score is 50 points. It is evaluated as mild between 1 and 10 points, moderate between 11 and 30 points, and severe between 31 and 50 points.

The Pittsburgh Sleep Quality Index

时间窗: 14 weeks

Pittsburgh Sleep Quality Index; It evaluates sleep duration, sleep disturbance, sleep efficiency, subjective sleep quality, sleep medication use, daytime dysfunction, and sleep delay and consists of a total of 24 questions. 19 of them are self-report scales and 5 of them consist of questions to be answered by a friend or spouse. There are 7 components with 18 questions scored in the scale, and each component is evaluated between 0 and 3 points. The total score ranges from 0 to 21, and 5 or more is an indicator of "poor sleep quality

Short form of the International Physical Activity Questionnaire

时间窗: 14 weeks

It consists of 8 questions with a recall period defined as 'last week'. The questions of the scale ask whether the participant walks for at least 10 minutes on any given day or does moderate or vigorous activities, and how much time/day the individual spends on each of these activities.

次要结局

未报告次要终点

研究者

发起方
Uskudar University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Öğr. Üyesi Ömer Şevgin

Asst. Prof. Dr.

Uskudar University

研究点 (2)

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