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

27 aprile 2026 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Effettivo)

367

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Illinois
      • Deerfield, Illinois, Stati Uniti, 60015
        • Curion Strategic Product Insights

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Chicago Marathon Runners who use topically applied menthol
Altro: Observational
Pain-experience observational study conducted during a marathon.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Mean Pain Score
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of participants reporting pain relief within 10 seconds after completed application of topically applied menthol.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Reckitt Benckiser Healthcare (UK) Limited

Investigatori

  • Investigatore principale: Neeta Yousaf, PHD, Curion Strategic Product Insights

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 ottobre 2025

Completamento primario (Effettivo)

12 ottobre 2025

Completamento dello studio (Effettivo)

12 ottobre 2025

Date di iscrizione allo studio

Primo inviato

5 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 aprile 2026

Primo Inserito (Effettivo)

4 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 5106901

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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