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Muscle SorenessNCT07565246

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

An observational study of Muscle Soreness, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Muscle Soreness
What is being tested?
Observational
How many people
367 participants
Where
1 siteUnited States
Study dates
12 Oct 2025to 12 Oct 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Curion Strategic Product Insights

    Deerfield, Illinois, 60015

Other trials in United States

About this study

Official title: 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?
Read more

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).
Read the 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.

Conditions
Muscle Soreness
Being tested
Observational
Medical subject headings
Myalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationalOther

    Pain-experience observational study conducted during a marathon.

Study groups in NCT07565246
Study groupRoleWhat they receive
Chicago Marathon Runners who use topically applied mentholNot described
Receives: Other: Observational

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Mean Pain Score

    Pain relief was assessed by change in Numeric Rating Scale (NRS) 0-10 pre and post topical menthol application.

    Measured: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.

Secondary outcomes (17)
  1. 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.

    Measured: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.

  2. 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.

    Measured: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.

  3. 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.

    Measured: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.

  4. 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

    Measured: 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.

  5. 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.

    Measured: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.

  6. 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.

    Measured: 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.

  7. 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.

    Measured: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.

  8. 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.

    Measured: 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.

  9. 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.

    Measured: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.

  10. 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.

    Measured: 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.

  11. 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

    Measured: 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.

  12. 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)

    Measured: 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.

  13. 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)

    Measured: 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.

  14. 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)

    Measured: 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.

  15. 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)

    Measured: 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.

  16. 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.

    Measured: 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.

  17. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2026
  2. Study start12 Oct 2025
  3. Primary completion12 Oct 2025
  4. Study completion12 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
367 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07565246
Sponsor's protocol ID
5106901
Status last verified
Apr 2026
First submitted
5 Mar 2026
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: IPD is completely anonymised and each participant can no longer be identified.

Questions about this trial

What is this clinical trial studying?

An observational study of Muscle Soreness, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mean Pain Score (time frame: Day 1 - immediately at the end of the race, assessed within the Recovery Application Zone Questionnaire.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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