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A Study to Understand the Analgesic Properties of Topically Applied Menthol When Used in a Marathon.

27 de abril de 2026 actualizado por: Reckitt Benckiser Healthcare (UK) Limited

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:

    1. Recovery Application Zone Questionnaire (includes pain score before and after Biofreeze application, sensory assessments, demographics).
    2. End of Race Questionnaire (includes retrospective recall of pain relief, product use, sensory experience, and demographic data).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

De observación

Inscripción (Actual)

367

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Illinois
      • Deerfield, Illinois, Estados Unidos, 60015
        • Curion Strategic Product Insights

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

This study will recruit runners over 18 years old, participating in the 2025 Chicago Marathon, capable of providing documented informed consent, who are not employees of Sponsor or the vendor collecting data.

Descripción

Inclusion Criteria:

  1. Participant has provided documented informed consent.
  2. Participant aged 18 years and above.
  3. Participant is entrant into the Chicago marathon 2025.
  4. Participant has self-selected to use topically applied menthol during the race or during immediate recovery.
  5. Comprehension of and able to read English.

Exclusion Criteria:

1. Employee of Sponsor or Agency/ vendor collecting the data

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Chicago Marathon Runners who use topically applied menthol
Otro: Observational
Pain-experience observational study conducted during a marathon.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Mean Pain Score
Periodo de tiempo: 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.
Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of participants reporting pain relief within 10 seconds after completed application of topically applied menthol.
Periodo de tiempo: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.

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.
Percentage of participants which report pain relief reduction of 2 points or greater on NRS within 10 seconds of topically applied menthol application.
Periodo de tiempo: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.

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.
Percentage of participants reporting a cooling sensation within 10 seconds/ immediately after application.
Periodo de tiempo: 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 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.
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
Periodo de tiempo: 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 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.
Rating of Intensity from the use of topically applied menthol when used after the marathon
Periodo de tiempo: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.

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.
Rating of Intensity from the use of topically applied menthol when used during the marathon
Periodo de tiempo: 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.

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.
Rating of Liking from the use of topically applied menthol when used after the marathon
Periodo de tiempo: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.

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.
Rating of Liking from the use of topically applied menthol when used during the marathon
Periodo de tiempo: 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.

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.
Percentage agreement that the cooling sensation from topically applied menthol helped to reduce pain.
Periodo de tiempo: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.
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.
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
Periodo de tiempo: 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.

Participants who respond, "strongly agree" or "agree" to Likert Scale statements in the End of Race Questionnaire:

  1. Biofreeze relieves pain;
  2. The cooling sensation from Biofreeze reduces pain;
  3. Biofreeze use during the race helped me run/ walk over the finish line by relieving my pain.
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
Periodo de tiempo: 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.

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.
Analysis of Covariance (ANCOVA) model to assess association between age and pain outcomes (severity, location), and topically applied menthol use during the marathon
Periodo de tiempo: 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.

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:

  • whether it was used (yes/no)
  • type of Biofreeze product used (roll-on; base gel; professional gel; aerosol spray; patch)
  • when it was used (during the race; after the race in the recovery zone; after the race)
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
Periodo de tiempo: 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.

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:

  • whether it was used (yes/no)
  • type of Biofreeze product used (roll-on; base gel; professional gel; aerosol spray; patch)
  • when it was used (during the race; after the race in the recovery zone; after the race)
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
Periodo de tiempo: 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.

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:

  • whether it was used (yes/no)
  • type of Biofreeze product used (roll-on; base gel; professional gel; aerosol spray; patch)
  • when it was used (during the race; after the race in the recovery zone; after the race)
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
Periodo de tiempo: 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.

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:

  • whether it was used (yes/no)
  • type of Biofreeze product used (roll-on; base gel; professional gel; aerosol spray; patch)
  • when it was used (during the race; after the race in the recovery zone; after the race)
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
Periodo de tiempo: 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.
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.
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
Periodo de tiempo: 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 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Reckitt Benckiser Healthcare (UK) Limited

Investigadores

  • Investigador principal: Neeta Yousaf, PHD, Curion Strategic Product Insights

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

12 de octubre de 2025

Finalización primaria (Actual)

12 de octubre de 2025

Finalización del estudio (Actual)

12 de octubre de 2025

Fechas de registro del estudio

Enviado por primera vez

5 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de abril de 2026

Publicado por primera vez (Actual)

4 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

27 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 5106901

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

IPD is completely anonymised and each participant can no longer be identified.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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