NCT07565246已完成不适用
A Real-world Evidence Study to Understand the Analgesic Properties of Topically Applied Menthol When Used in a Marathon.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 367
- 试验地点
- 1
- 主要终点
- Change in Mean Pain Score
研究概览
简要总结
The purpose of the research study is to gather the opinions and/or perceptions relating to the use of topically applied menthol and experience of pain during and after a marathon in adult runners (18+ years) participating in the 2025 Chicago Marathon. The main questions it aims to answer are:
- Does topically applied menthol reduce pain levels in marathon runners during recovery?
- How quickly does pain relief occur after topically applied menthol application?
- What are the sensory attributes (e.g., cooling sensation) associated with topically applied menthol use during and after the race?
- How do demographic factors (e.g., age, sex, menstrual cycle stage, sleep quality) influence pain experience and topically applied menthol effectiveness?
Researchers will compare pre- and post-application pain scores in the Recovery Application Zone to see if Biofreeze provides measurable pain relief and sensory benefits.
Participants will:
- Provide documented informed consent prior to participation.
- Self-select to use Biofreeze products during or after the race.
- Complete one or both of the following:
- Recovery Application Zone Questionnaire (includes pain score before and after Biofreeze application, sensory assessments, demographics).
- End of Race Questionnaire (includes retrospective recall of pain relief, product use, sensory experience, and demographic data).
详细描述
This is a real-world, observational study evaluating self-selected use of topically applied menthol among runners in the 2025 Chicago Marathon.
Participants independently choose whether to use topically applied menthol products, which products to use, and how frequently to apply them as part of their usual pain-management behaviour.
The study does not assign or administer any intervention. Data are collected from participants who voluntarily used topically applied menthol and chose to complete the questionnaires.
Participants may self-select to use topically applied menthol products during the race or recovery as they normally would. Researchers do not assign or direct product use. Product application occurs independently of study participation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant has provided documented informed consent.
- •Participant aged 18 years and above.
- •Participant is entrant into the Chicago marathon
- •Participant has self-selected to use topically applied menthol during the race or during immediate recovery.
- •Comprehension of and able to read English.
排除标准
- •1. Employee of Sponsor or Agency/ vendor collecting the data
研究组 & 干预措施
Chicago Marathon Runners who use topically applied menthol
干预措施: Observational (Other)
结局指标
主要结局
Change in Mean Pain Score
时间窗: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.
Pain relief was assessed by change in Numeric Rating Scale (NRS) 0-10 pre and post topical menthol application.
次要结局
- Proportion of participants reporting pain relief within 10 seconds after completed application of topically applied menthol.(Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.)
- Percentage of participants which report pain relief reduction of 2 points or greater on NRS within 10 seconds of topically applied menthol application.(Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.)
- Percentage of participants reporting a cooling sensation within 10 seconds/ immediately after application.(Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.)
- Percentage of participants experiencing cooling sensation lasting 2 hours or more after topically applied menthol use(Retrospective recall data from the End of Race Questionnaire was completed on Day 1: Completed at least 2 hours after the end of the race, up to 23:59 on race day.)
- Rating of Intensity from the use of topically applied menthol when used after the marathon(Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.)
- Rating of Intensity from the use of topically applied menthol when used during the marathon(Retrospective recall data from the end of race questionnaire was completed on Day 1: Completed at least 2 hours after the end of the race, up to 23:59 on race day.)
- Rating of Liking from the use of topically applied menthol when used after the marathon(Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.)
- Rating of Liking from the use of topically applied menthol when used during the marathon(Retrospective recall data from the End of Race Questionnaire was completed on Day 1: Completed at least 2 hours after the end of the race, up to 23:59 on race day.)
- Percentage agreement that the cooling sensation from topically applied menthol helped to reduce pain.(Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.)
- Proportion of participants agreement regarding statements about topically applied menthol(Retrospective recall data from the End of Race Questionnaire was completed on Day 1: Completed at least 2 hours after the end of the race, up to 23:59 on race day.)
- Percentage of participants experiencing pain relief lasting 2 hours or more after topically applied menthol(Retrospective recall data from the End of Race Questionnaire was completed on Day 1: Completed at least 2 hours after the end of the race, up to 23:59 on race day.)
- Analysis of Covariance (ANCOVA) model to assess association between age and pain outcomes (severity, location), and topically applied menthol use during the marathon(Retrospective recall data from the End of Race Questionnaire was completed on Day 1: Completed at least 2 hours after the end of the race, up to 23:59 on race day.)
- Analysis of Covariance (ANCOVA) model to assess association between sex and pain outcomes (severity, location), and topically applied menthol use during the marathon(Retrospective recall data from the End of Race Questionnaire was completed on Day 1: Completed at least 2 hours after the end of the race, up to 23:59 on race day.)
- Analysis of Covariance (ANCOVA) model to assess association between menstrual cycle stage, menopausal status and pain outcomes (severity, location), and topically applied menthol use during the marathon(Retrospective recall data from the End of Race Questionnaire was completed on Day 1: Completed at least 2 hours after the end of the race, up to 23:59 on race day.)
- Analysis of Covariance (ANCOVA) model to assess association between amount of sleep, quality of sleep the night before the marathon and pain outcomes (severity, location), and topically applied menthol use during the marathon(Retrospective recall data from the End of Race Questionnaire was completed on Day 1: Completed at least 2 hours after the end of the race, up to 23:59 on race day.)
- Types of oral analgesic products used alongside topically applied menthol(Retrospective recall data from the End of Race Questionnaire was completed on Day 1: Completed at least 2 hours after the end of the race, up to 23:59 on race day.)
- Number of participants who used analgesic products alongside topically applied menthol for pain relief during marathon(Retrospective recall data from the End of Race Questionnaire was completed on Day 1: Completed at least 2 hours after the end of the race, up to 23:59 on race day.)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Sodium Alginate antacid combination on quality of life, Tolerability and effectiveness in GERD patientsCTRI/2024/07/070568Alembic Pharmaceuticals Ltd.10,000
招募中
不适用
Neoadjuvant Therapy With Tislelizumab for dMMR/MSI-H Stage II-III Colorectal CancerNCT07352280Cancer Institute and Hospital, Chinese Academy of Medical Sciences30
尚未招募
不适用
Studying the Role of Indicated Homoeopathic Medicines in Controlling Type-2 Diabetes MellitusCTRI/2025/07/090555C.D. Pachchigar College of Homoeopathic Medicine and Hospital30
尚未招募
2 期
A Study of Ashwagandha Churna and Madanphaladi Pottali in the management of Garbhashaya Yoni BhramshaCTRI/2024/11/076497Post Graduate Department of Prasuti Tantra evam Stri Roga State Ayurvedic college and hospital40
尚未招募
不适用
For Patients With Myocardial Infarction and Multiple Vessel: Testing if Ultrasound (UFR) Can Guide All Needed Treatment in One Procedure, Avoiding a Return Hospital Visit for a Second Operation.NCT07264881Beijing Anzhen Hospital200