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Clinical Trials/NCT07511452
NCT07511452Enrolling By InvitationNot Applicable

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

Fenerbahce University1 site in 1 country55 target enrollmentStarted: March 30, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
55
Locations
1
Primary Endpoint
Pressure Pain Threshold of the Tibial Nerve

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Fenerbahce University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sümeyye Akçay

Asst. Prof.

Fenerbahce University

Study Sites (1)

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