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临床试验/NCT07533617
NCT07533617已完成不适用

Ergonomic Effects of Material- and Geometry-Modified, Chair-Integrated Foams on Pressure Distribution, Pain, and Sitting Comfort in Individuals With Coccydynia

KTO Karatay University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年5月1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
48
试验地点
1
主要终点
Pressure Distribution Measurement (Load Cell-Equipped Chair System)

研究概览

简要总结

The aim of this study is to evaluate the effects of chairs with different ergonomic designs on quality of life, discomfort, and pain in individuals with coccydynia (tailbone pain).

详细描述

Participants aged 18-65 years who work at a desk for at least 5-6 hours per day will be included in the study. Information such as age, height, body weight, education level, family type, smoking status, sex, marital status, working posture (sitting, standing, or both), duration of working hours, job type (production or administrative), regular exercise habits, presence of chronic diseases, and absence of any spinal problems (e.g., no diagnosed lumbar disc herniation) will be recorded. Participants will be randomly assigned to six groups. Before using the chairs, participants will be seated on a load cell-equipped chair to assess weight distribution. The distribution of body weight across different regions while sitting will be recorded in kilograms. This measurement will be repeated three times, and the average will be recorded.

After the measurement, participants will be provided with specially designed chairs and asked to work using these chairs. Six different chair designs will be developed for the study. The reason for having six types of chairs is that the foam properties used in each chair will differ from one another.

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
None

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

  • Aged between 18 and 65 years
  • Working at a desk for at least 5-6 hours per day
  • Experiencing coccydynia (tailbone pain)
  • Able to sit independently without assistive support
  • No diagnosed spinal disorders (e.g., lumbar disc herniation)
  • Willing to use the assigned chair during working hours for 1 week
  • Able to understand and complete questionnaires
  • Provided written informed consent

排除标准

  • History of spinal surgery
  • Diagnosed spinal disorders (e.g., lumbar disc herniation, scoliosis, severe degenerative spine disease)
  • Neurological disorders affecting posture, sitting balance, or sensation
  • Severe musculoskeletal conditions (e.g., hip or pelvic disorders) that may affect sitting
  • Pregnancy
  • Inability to sit for prolonged periods
  • Use of assistive seating devices (e.g., orthopedic cushions) during the study period
  • Regular use of pain medication that may affect outcome measures

研究组 & 干预措施

Group 1: Chair with Foam Type A

Experimental

Participants will use ergonomically modified chair A with different foam properties during their working hours.

干预措施: Ergonomic Chair with Foam Type A (Device)

Group 2: Chair with Foam Type B

Experimental

Participants will use ergonomically modified chair B with different foam properties during their working hours.

干预措施: Ergonomic Chair with Foam Type B (Device)

Group 3: Chair with Foam Type C

Experimental

Participants will use ergonomically modified chair C with different foam properties during their working hours.

干预措施: Ergonomic Chair with Foam Type C (Device)

Group 4: Chair with Foam Type D

Experimental

Participants will use ergonomically modified chair D with different foam properties during their working hours.

干预措施: Ergonomic Chair with Foam Type D (Device)

Group 5: Chair with Foam Type E

Experimental

Participants will use ergonomically modified chair E with different foam properties during their working hours.

干预措施: Ergonomic Chair with Foam Type E (Device)

Group 6: Chair with Foam Type F

Experimental

Participants will use ergonomically modified chair F with different foam properties during their working hours.

干预措施: Ergonomic Chair with Foam Type F (Device)

结局指标

主要结局

Pressure Distribution Measurement (Load Cell-Equipped Chair System)

时间窗: Baseline + 1 week

Assessment of sitting pressure distribution across right, left, and central regions in kilograms using a custom-designed load cell-integrated chair.

Paris Questionnaire

时间窗: Baseline + 1 week

Evaluation of pain and functional status associated with coccydynia.

次要结局

  • Extended Nordic Musculoskeletal Questionnaire (NMQ-E)(Baseline + 1 week)
  • EuroQol Quality of Life Scale (EQ-5D-3L)(Baseline + 1 week)

研究者

发起方
KTO Karatay University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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