跳至主要内容
临床试验/NCT07839520
NCT07839520尚未招募不适用

Machine Learning-Based Pain Prediction in University Students: Electrical Threshold Measurements and Interoception

Amasya University1 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2026年10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
尚未招募
入组人数
550
试验地点
1
主要终点
Retrospective Pain

研究概览

简要总结

The goal of this observational study is to predict (retrospective and prospective) musculoskeletal pain in university students using machine learning models based on electrical threshold measurements and interoceptive awareness. The main question it aims to answer is:

Can electrical sensory, motor, and pain thresholds, along with interoceptive awareness scores, predict musculoskeletal pain status in young adults using machine learning algorithms?

Participants will:

Complete demographic, healthy lifestyle (physical activity, sitting time, meal frequency), and substance use (ASSIST v3.0) questionnaires.

Complete self-report surveys including the Nordic Musculoskeletal Questionnaire (NMQ) and the Multidimensional Assessment of Interoceptive Awareness (MAIA-2).

Undergo quantitative electrical threshold testing on their dominant hand, which includes 3 consecutive measurements of sensory threshold, motor threshold (after a 10-minute rest), and pain threshold (after another 10-minute rest).

详细描述

The aim of this study is to investigate the relationship between musculoskeletal pain, electrical threshold values, and interoception in healthy university students, and to evaluate the predictive accuracy of machine learning models for both retrospective and prospective musculoskeletal pain.

Designed as an observational, analytical, and cross-sectional study with a prospective follow-up component, this study will include approximately 550 healthy, right-hand dominant students aged 18-25 who provide written informed consent.

Participants' demographic data and healthy lifestyle behaviors (physical activity, sitting time, nutrition, and tobacco/alcohol/substance use via ASSIST) will be recorded. Musculoskeletal complaints will be evaluated using the Nordic Musculoskeletal Questionnaire, and interoception will be assessed using the Multidimensional Assessment of Interoceptive Awareness-II. Finally, electrical sensory, motor, and pain thresholds will be measured using a combined electrotherapy device with electrodes placed over the flexor muscles of the forearm. One week later, participants will be contacted again to re-evaluate their pain complaints during the preceding 7 days.

In statistical analyses, in addition to correlation and regression analyses among parameters, the performance of three machine learning models-Logistic Regression, Random Forest, and XGBoost-in predicting participants' retrospective and prospective pain will be evaluated.

The research results will demonstrate several key outcomes. First, they will elucidate the relationship between musculoskeletal pain, electrical threshold values, and interoception in university students, while testing the utility of electrical threshold values as an objective tool in musculoskeletal pain assessment. Furthermore, the study will evaluate the accuracy of machine learning models in predicting both retrospective and prospective pain within this population. By leveraging objective measurements obtained from widely accessible clinical devices, the findings will contribute to digital health approaches and applications that guide researchers and clinicians throughout pain evaluation and treatment processes. Ultimately, this work will provide critical insights into the efficacy of the proposed research methodology before its implementation in diverse patient populations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Being healthy and aged 18-25
  • •Having the right hand as the dominant extremity
  • •Being able to communicate effectively and understand the study procedure
  • •Being willing to participate in the study and having signed the written informed consent

排除标准

  • •Presence of continuous or periodic pain in the same region over the last 3 months (presence of chronic pain)
  • •Presence of sleep problems
  • •History of severe menstrual or abdominal pain
  • •Diagnosis of an endocrinological, psychiatric, urogenital, neurological, dermatological, cardiorespiratory, or musculoskeletal disease and/or sleep disorder that could be related to the study outcomes
  • •Being pregnant or the possibility of pregnancy
  • •Criteria for withdrawal from the study:
  • •Deciding not to participate in the study and not wishing to complete the assessments
  • •Experiencing discomfort due to the assessments and measurements and not wishing to complete them

研究组 & 干预措施

university students with healthy lifestyle

干预措施: No Intervention: Observational Cohort (Other)

结局指标

主要结局

Retrospective Pain

时间窗: baseline

Self-reported musculoskeletal pain presence and anatomical localization over the preceding 12 months and past 7 days, assessed using the Nordic Musculoskeletal Questionnaire (NMQ). The NMQ is a standardized screening instrument that evaluates musculoskeletal symptoms (pain, ache, or discomfort) across 9 distinct body regions (neck, shoulders, elbows, wrists/hands, upper back, lower back, hips/thighs, knees, and ankles/feet).

Prospective Pain

时间窗: 1 week post-baseline

Presence and anatomical site of self-reported prospective musculoskeletal pain or discomfort experienced during the 1-week follow-up period. Participants will be re-evaluated via a structured telephone or digital questionnaire inquiring about any newly developed or ongoing musculoskeletal pain symptoms in the preceding 7 days. Pain presence is recorded as a binary outcome (Yes/No) for overall pain and for specific body regions.

Electrical Sensory, Motor, and Pain Thresholds

时间窗: baseline

Quantitative evaluation of somatosensory processing using a standardized monochromatic combined electrotherapy device (Intelect Advanced Monochromatic Combo). Electrodes ($5\\times5$ cm) will be placed over the wrist flexor muscles on the anterior aspect of the dominant forearm using a symmetric biphasic square wave (100 Hz frequency, 100 µs phase duration, current increased at a rate of 1 mA/s). Three threshold parameters will be measured in milliamperes (mA):Electrical Sensory Threshold (EST): The minimum current intensity at which the participant first perceives a tingling or sensory stimulus.Electrical Motor Threshold (EMT): The minimum current intensity required to elicit a visible muscle contraction.Electrical Pain Threshold (EPT): The minimum current intensity at which the electrical sensation first becomes painful.

Interoceptive Awareness

时间窗: baseline

Multidimensional self-reported interoceptive bodily awareness assessed using the Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) scale. The MAIA-2 is a 37-item questionnaire evaluated on a 6-point Likert scale (0= Never to 5=Always) across 8 distinct subscales: Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, Trust. Subscale scores are calculated as the mean of their respective items (range: 0 to 5), with higher scores indicating higher levels of interoceptive awareness.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aybike Senel

Assistant Professor

Amasya University

研究点 (1)

Loading locations...

相似试验