A Study to Understand the Analgesic Properties of Topically Applied Menthol When Used in a Marathon.
A Real-world Evidence Study to Understand the Analgesic Properties of Topically Applied Menthol When Used in a Marathon.
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).
Visão geral do estudo
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Illinois
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Deerfield, Illinois, Estados Unidos, 60015
- Curion Strategic Product Insights
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Participant has provided documented informed consent.
- Participant aged 18 years and above.
- Participant is entrant into the Chicago marathon 2025.
- Participant has self-selected to use topically applied menthol during the race or during immediate recovery.
- Comprehension of and able to read English.
Exclusion Criteria:
1. Employee of Sponsor or Agency/ vendor collecting the data
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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Chicago Marathon Runners who use topically applied menthol
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Pain-experience observational study conducted during a marathon.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Mean Pain Score
Prazo: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.
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Pain relief was assessed by change in Numeric Rating Scale (NRS) 0-10 pre and post topical menthol application.
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Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of participants reporting pain relief within 10 seconds after completed application of topically applied menthol.
Prazo: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.
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Characterising the speed of analgesic effect from topically applied menthol in participants recovering from marathon. Number of subjects whose pain score based on 0-10 NRS rating reduced from pre-application to post-application, whose post-application score was within 10 seconds. |
Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.
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Percentage of participants which report pain relief reduction of 2 points or greater on NRS within 10 seconds of topically applied menthol application.
Prazo: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.
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Characterising the speed of analgesic effect from topically applied menthol in participants recovering from marathon. Number of subjects whose pain score based on 0-10 Numerical Rating Scale rating reduced over 2 points from pre-application to post- application, whose post-application score was reported within 10 seconds. |
Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.
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Percentage of participants reporting a cooling sensation within 10 seconds/ immediately after application.
Prazo: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.
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Percentage of participants reporting a cooling sensation within 10 seconds or immediately after application.
Participants reported if they experienced a cooling sensation (YES/ NO) and for the next question, reported if that occurred within 10 seconds / immediately after application or over 10 seconds.
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Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.
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Percentage of participants experiencing cooling sensation lasting 2 hours or more after topically applied menthol use
Prazo: 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.
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Percentage of participants experiencing cooling sensation lasting 2 hours or more after topically applied menthol use, by product, participants who reported a cooling sensation (YES/ NO) and for the next question, participants reported duration of cooling assessed as follows: 1.Less than 10 minutes 2.10 minutes to less than 30 minutes 3.30 minutes to less than 60 minutes 4.60 minutes to less than 2 hours 5.2 hours to less than 3 hours 6.3 hours to less than 4 hours 7.4 hours or more |
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.
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Rating of Intensity from the use of topically applied menthol when used after the marathon
Prazo: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.
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Average rating for intensity from the use of topically applied menthol when used after the marathon. Intensity of cooling sensation is assessed post application of topically applied menthol, calculated using a 1-10 Rating Scale question to rate intensity of cooling sensation, where 1 is a mild cooling sensation, 10 is an extremely intense cooling sensation. |
Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.
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Rating of Intensity from the use of topically applied menthol when used during the marathon
Prazo: 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.
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Average rating for intensity from the use of topically applied menthol when used during the marathon. Intensity of cooling sensation is assessed post application of topically applied menthol, calculated using a 1-10 Rating Scale question on intensity of cooling sensation: scale 1-10, where 1 is a mild cooling sensation, 10 is an extremely intense cooling sensation. |
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.
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Rating of Liking from the use of topically applied menthol when used after the marathon
Prazo: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.
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Average rating for overall liking from the use of topically applied menthol when used after the marathon. Overall liking of cooling sensation is assessed post application of topically applied menthol, calculated using a 1-10 Rating Scale question to rate overall liking of cooling sensation, where 1 is dislike extremely and 10 is like extremely. |
Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.
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Rating of Liking from the use of topically applied menthol when used during the marathon
Prazo: 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.
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Average rating for overall liking from the use of topically applied menthol when used during the marathon. Overall liking of cooling sensation is assessed post application of topically applied menthol, calculated using a 1-10 Rating Scale question to rate overall liking of cooling sensation, where 1 is dislike extremely and 10 is like extremely. |
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.
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Percentage agreement that the cooling sensation from topically applied menthol helped to reduce pain.
Prazo: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.
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Based on data collected in the Recovery Application Zone Questionnaire, the number of subjects who respond, "strongly agree" and "agree" to Likert Scale statement that the cooling sensation from topically applied menthol helped to reduce pain.
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Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.
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Proportion of participants agreement regarding statements about topically applied menthol
Prazo: 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.
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Participants who respond, "strongly agree" or "agree" to Likert Scale statements in the End of Race Questionnaire:
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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.
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Percentage of participants experiencing pain relief lasting 2 hours or more after topically applied menthol
Prazo: 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.
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Based on retrospective recall data from the End of Race Questionnaire, participants who responded to a single-select question: 2 hours to less than 3 hours, 3 hours to less than 4 hours, 4 hours or more |
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.
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Analysis of Covariance (ANCOVA) model to assess association between age and pain outcomes (severity, location), and topically applied menthol use during the marathon
Prazo: 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.
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To assess impact of the following aspects on pain experience (pain severity and location and topically applied menthol use) during the marathon (based on retrospective recall data from the End of Race Questionnaire): Age (self reported: ranges in years: 18-25; 26-35; 36-45; 46-55; 56-65; 66-75; 76 or older) Pain Severity: (self-rated pain before use & immediately after Biofreeze use, both via Numeric Rating Scales 0-10 where 0 is no pain and 10 is the worst pain imaginable) Pain Location (self-reported pain regions, e.g. pelvis; groin; knee; none of these) Biofreeze Use:
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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.
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Analysis of Covariance (ANCOVA) model to assess association between sex and pain outcomes (severity, location), and topically applied menthol use during the marathon
Prazo: 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.
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To assess impact of the following aspects on pain experience (pain severity and location and topically applied menthol use) during the marathon (based on retrospective recall data from the End of Race Questionnaire): Sex (self reported: male; female; non-binary; prefer not to say) Pain Severity: (self-rated pain before use & immediately after Biofreeze use, both via Numeric Rating Scales 0-10 where 0 is no pain and 10 is the worst pain imaginable) Pain Location (self-reported pain regions, e.g. pelvis; groin; knee; none of these) Biofreeze Use:
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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.
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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
Prazo: 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.
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To assess impact of the following aspects on pain experience (pain severity and location and topically applied menthol use) during the marathon (based on retrospective recall data from the End of Race Questionnaire): Menstrual cycle stage and menopausal status (self-reported status; for example Have menstrual cycle, was on my period; Post menopausal) Pain Severity: (self-rated pain before use & immediately after Biofreeze use, both via Numeric Rating Scales 0-10 where 0 is no pain and 10 is the worst pain imaginable) Pain Location (self-reported pain regions, e.g. pelvis; groin; knee; none of these) Biofreeze Use:
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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.
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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
Prazo: 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.
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To assess impact of the following aspects on pain experience (pain severity and location and topically applied menthol use) during the marathon (based on retrospective recall data from the End of Race Questionnaire): Amount and quality of sleep the night before the marathon: (self reported: hours slept example: less than 1 hour, 2 hours to less than 3, 3 hours to less than 4, more than 8 hours; Sleep quality: very good; fairly good; fairly bad; very bad) Pain Severity: (self-rated pain before use & immediately after Biofreeze use, both via Numeric Rating Scales 0-10 where 0 is no pain and 10 is the worst pain imaginable) Pain Location (self-reported pain regions, e.g. pelvis; groin; knee; none of these) Biofreeze Use:
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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.
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Types of oral analgesic products used alongside topically applied menthol
Prazo: 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.
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Participants reported types of oral analgesia used alongside topically applied menthol during the marathon and recovery period through the following question (option to select): Ibuprofen /Acetaminophen /Opioid /Naproxen /Aspirin / Combination Analgesic / Other.
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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.
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Number of participants who used analgesic products alongside topically applied menthol for pain relief during marathon
Prazo: 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.
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Types of oral analgesia used alongside topically applied menthol and number of participants who used each during the race and recovery period. Participants reported use of oral analgesic products alongside topically applied menthol by single-select (YES/NO) question. |
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.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Neeta Yousaf, PHD, Curion Strategic Product Insights
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Dor
- Manifestações Neurológicas
- Doenças musculoesqueléticas
- Doenças do Sistema Nervoso
- Doenças Musculares
- Doenças Neuromusculares
- Dor musculoesquelética
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Mialgia
- Administração de Serviços de Saúde
- Qualidade de assistência médica
- Avaliação de resultados, assistência médica
- Avaliação de resultados e processos, assistência médica
- Esperando vigilante
Outros números de identificação do estudo
- 5106901
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