跳至主要内容
临床试验/NCT07511452
NCT07511452Enrolling By Invitation不适用

The Effects of Health-Related Lifestyle Factors and Sex on Neural Mechanosensitivity in University Students

Fenerbahce University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2026年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
55
试验地点
1
主要终点
Pressure Pain Threshold of the Tibial Nerve

研究概览

简要总结

This observational cross-sectional study aims to investigate the effects of health-related lifestyle factors and sex on neural mechanosensitivity in university students. Specifically, the study will examine whether alcohol consumption, smoking status, physical activity level, age, body mass index, and sex are associated with pressure pain thresholds of the tibial and peroneal nerves.

Participants will be university students aged 18 to 30 years enrolled at Fenerbahçe University who voluntarily agree to participate and provide informed consent. Students with neurological disorders, lower extremity musculoskeletal injury or surgery, acute pain, systemic conditions affecting nerve sensitivity, skin problems at the measurement sites, or use of medications that may influence the measurements will be excluded.

Data will be collected face to face. Participants will complete a personal information form including demographic characteristics and lifestyle-related factors. Neural mechanosensitivity will be assessed by measuring pressure pain threshold over the tibial and peroneal nerve regions using a digital algometer. Three measurements will be obtained at each site and the average value will be used for analysis.

The study is expected to improve understanding of factors associated with peripheral nerve mechanosensitivity in young adults and may provide a scientific basis for future clinical and epidemiological research.

详细描述

This is an observational, analytical, cross-sectional study designed to evaluate neural mechanosensitivity in healthy university students and to explore its association with health-related lifestyle factors and sex. The main objective is to determine whether alcohol consumption, smoking status, physical activity level, sex, age, and body mass index are associated with pressure pain threshold values measured over the tibial and peroneal nerves.

The study population will consist of students enrolled at Fenerbahçe University. Participants must be between 18 and 30 years of age, willing to participate voluntarily, and able to provide written informed consent. Individuals will be excluded if they have a diagnosed neurological disease, lower extremity musculoskeletal injury or previous surgery, acute pain, diabetes, peripheral neuropathy, systemic disorders that may affect nerve sensitivity, skin lesions or infection at the test site, or use of analgesic or neurologically active medication that could influence the measurements.

Data will be collected in person. After informed consent is obtained, participants will complete a personal information form developed by the investigators. This form will record sociodemographic characteristics and lifestyle-related variables, including age, sex, height, weight, alcohol consumption, smoking status, and physical activity habits. Body mass index will be calculated from height and weight data.

Neural mechanosensitivity will be assessed by pressure pain threshold measurements using a digital algometer. Measurements will be performed over standardized anatomical points corresponding to the tibial nerve and the common peroneal nerve. Pressure will be increased gradually at an approximate rate of 0.5 to 1 kg/cm²/s, and participants will be instructed to indicate when the sensation first becomes painful. Three repeated measurements will be obtained at each site, and the mean value will be used in the analyses. The algometer will be checked according to the manufacturer's calibration standards.

The planned minimum sample size is 55 participants, based on an a priori power analysis performed with G*Power 3.1, assuming an alpha of 0.05, a statistical power of 0.80, and a medium effect size. Statistical analyses will be conducted using IBM SPSS Statistics version 22. Descriptive statistics will summarize participant characteristics. Normality will be assessed using the Shapiro-Wilk test and visual methods. Group comparisons for lifestyle-related factors will be performed using one-way ANOVA, sex differences will be examined using the independent samples t-test, associations with age and body mass index will be tested using Pearson correlation analysis, and linear regression analysis will be used to further evaluate the effect of sex on pressure pain threshold values. Statistical significance will be set at p < 0.05.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Students enrolled at Fenerbahçe University
  • Aged 18 to 30 years
  • Willing to participate voluntarily
  • Able to provide written informed consent
  • No health problem preventing measurement in the tibial and peroneal nerve regions

排除标准

  • Diagnosed neurological disease
  • Lower extremity musculoskeletal injury, previous surgery, or acute pain
  • Diabetes, peripheral neuropathy, or other systemic disease that may affect nerve sensitivity
  • Open wound, infection, or skin problem at the measurement site
  • Use of analgesic or neurologically active medication that may affect the measurements

研究组 & 干预措施

Healthy University Students

University students aged 18 to 30 years enrolled at Fenerbahçe University who voluntarily participate in the study and undergo assessment of lifestyle factors and neural mechanosensitivity.

结局指标

主要结局

Pressure Pain Threshold of the Tibial Nerve

时间窗: At baseline (single assessment)

Pressure pain threshold measured over the tibial nerve region using a digital algometer. Three measurements will be obtained and the mean value will be used for analysis.

Pressure Pain Threshold of the Common Peroneal Nerve

时间窗: At baseline (single assessment)

Pressure pain threshold measured over the common peroneal nerve region using a digital algometer. Three measurements will be obtained and the mean value will be used for analysis.

次要结局

未报告次要终点

研究者

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

Sümeyye Akçay

Asst. Prof.

Fenerbahce University

研究点 (1)

Loading locations...

相似试验