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NCT Number: NCT07511452

Health-Related Lifestyle Factors, Sex, and Neural Mechanosensitivity in University Students

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fenerbahçe University

Istanbul, Ataşehir, 34758, Turkey (Türkiye)

About this study

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.

This study is expected to provide information about factors associated with peripheral nerve mechanosensitivity in young adults and may contribute to future clinical and epidemiological research in physiotherapy and rehabilitation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Pressure Pain Threshold of the Tibial Nerve

    Time frame: 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.

  2. Pressure Pain Threshold of the Common Peroneal Nerve

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fenerbahce University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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