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Clinical Trials/NCT07565246
NCT07565246CompletedNot Applicable

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

Reckitt Benckiser Healthcare (UK) Limited1 site in 1 country367 target enrollmentStarted: October 12, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
367
Locations
1
Primary Endpoint
Change in Mean Pain Score
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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).

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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.

Exclusion Criteria

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

Arms & Interventions

Chicago Marathon Runners who use topically applied menthol

Intervention: Observational (Other)

Outcomes

Primary Outcomes

Change in Mean Pain Score

Time Frame: 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.

Secondary Outcomes

  • 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.)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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