An observational study in Muscle Soreness, sponsored by Reckitt Benckiser Healthcare (UK) Limited. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Reckitt Benckiser Healthcare (UK) Limited · Observational
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:
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:
Complete one or both of the following:
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.
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.
Exclusion Criteria:
1. Employee of Sponsor or Agency/ vendor collecting the data
Other: Observational
Pain-experience observational study conducted during a marathon.
Change in Mean Pain Score
Pain relief was assessed by change in Numeric Rating Scale (NRS) 0-10 pre and post topical menthol application.
Time frame: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.
Proportion of participants reporting pain relief within 10 seconds after completed application of topically applied menthol.
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.
Time frame: 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.
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.
Time frame: 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.
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.
Time frame: 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
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
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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.
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.
Time frame: 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
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.
Time frame: 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
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
Time frame: 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
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)
Time frame: 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
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)
Time frame: 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
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)
Time frame: 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
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)
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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.
Plan to share: No — IPD is completely anonymised and each participant can no longer be identified.
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Reckitt Benckiser Healthcare (UK) Limited