Muscle SorenessNCT07873242
A Study to Evaluate the Analgesic Properties of Topically Applied Menthol in Marathon Participants
An observational study of Muscle Soreness, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in United States.
Trial summary
The purpose of the research study is to better understand the factors that impact pain experience in adult (18+ years) marathon runners participating in the 2026 Chicago Marathon and to better understand if topically applied menthol provides effective pain relief and impacts quality-of-life outcomes when used during… 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 and Non-Interventional Study
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2026to 13 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2026 Chicago Marathon, capable of providing documented informed consent, who are not employees of Reckitt 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 an entrant into the Chicago marathon 2026.
- Participant has self-selected to use Biofreeze 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. Contact the study team or a site near you to ask about taking part.
United States1 site
Curion Insights LLC
Deerfield, Illinois, 60015
Principal Investigator, 800-291-1907, nyousaf@curioninsights.com
Neeta Yousaf, PhD
About this study
Official title: A Real-World Evidence Study to Evaluate the Analgesic Properties of Topically Applied Menthol and Its Impact on Quality of Life in Marathon Participants
The purpose of the research study is to better understand the factors that impact pain experience in adult (18+ years) marathon runners participating in the 2026 Chicago Marathon and to better understand if topically applied menthol provides effective pain relief and impacts quality-of-life outcomes when used during the marathon, in the Recovery Zone immediately after the marathon, or during post-race recovery.
The main questions the study aims to answer are:
Read more
- Does topically applied menthol (gel and roll-on formats) reduce pain when applied in the Recovery Zone immediately after a marathon?
- What are the sensory attributes (e.g., cooling sensation) of topically applied menthol (gel and roll-on) when used in the Recovery Zone immediately after a marathon?
- How do participants assess the effects of topically applied menthol products used during and/or after a marathon on pain relief, performance, recovery, and sleep-related quality-of-life outcomes? Researchers will evaluate participant-reported pre- and post-application pain scores in the Recovery Zone immediately following the marathon and post-race outcomes to assess analgesic effectiveness, sensory attributes, and quality-of-life outcomes associated with Biofreeze use.
Participants will:
- Provide documented informed consent prior to participation.
- Self-select to use Biofreeze products during and/or after the race.
- Complete one or both of the following:
- End of Race Questionnaire (includes pain score before and after Biofreeze application, sensory assessments, and demographics).
- Post-Race Questionnaire (includes retrospective recall of pain relief, product use, sensory experience, sleep-related outcomes and demographic data).
Read the detailed description
This observational, real-world evidence study will evaluate pain relief, sensory attributes, and quality-of-life outcomes among adult (18+ years) runners participating in the 2026 Chicago Marathon who independently choose to use Biofreeze at the end of the marathon in the Recovery Zone, or after the race.
Biofreeze products are available to runners irrespective of study participation, and participants independently decide whether to use Biofreeze and which product format to use.
The study will collect information through two questionnaires: End of Race Questionnaire completed in the Recovery Zone immediately following the marathon and Post-Race Questionnaire completed after the race. Data collected through the two questionnaires will not be linked. Participants will provide separate informed consent before completing each questionnaire.
For the End of Race Questionnaire, runners who independently enter the Recovery Zone and choose to use Biofreeze will be invited to participate. After providing informed consent, participants will report their pain intensity before applying their selected Biofreeze product and after application using a Numerical Rating Scale (NRS). Information on product format, pain location, cooling sensation and related sensory attributes, and demographic characteristics will also be collected.
The primary evaluation will assess the analgesic effect of topically applied menthol gel and roll-on formulations in the Recovery Zone, based on changes in participant-reported NRS pain scores.
Secondary evaluations will assess clinically meaningful reduction in pain, sensory attributes associated with product use, sensory attributes, pain-relieving effects of Biofreeze used during and/or after the marathon, and recovery- and sleep-related quality-of-life outcomes.
The Post-Race Questionnaire will collect participant-reported information on Biofreeze use during and/or after the marathon, including pain relief, sensory attributes, duration of pain relief, and perceived effects on performance, recovery, and sleep-related outcomes, as well as demographic characteristics.
- Conditions
- Muscle Soreness
- Being tested
- Observational, Non-Interventional Study
- Keywords
- Biofreeze, Topical-applied menthol
- 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 and after a marathon.
Non-Interventional StudyOther
Non-Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| Chicago Marathon Runners who use topically applied menthol | Chicago Marathon Runners over 18 years who use topically applied menthol during and after the race Receives: Other: Observational; Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Post-Application Pain Score (Gel Format)
Mean change in post-application pain score, based on pre-application NRS and post-application NRS when topical menthol gel is applied after the race. Pain intensity will be assessed using an 11-point NRS, where 0 indicates no pain and 10 indicates the worst possible pain, based on data collected in the End of Race Questionnaire (Recovery Zone). Negative values indicate a reduction in pain.
Measured: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone) Questionnaire
Mean Change in Post-Application Pain Score (Roll-On Format)
Mean change in post-application pain score, based on pre-application NRS and post-application NRS when topical menthol roll-on is applied after the race. Pain intensity will be assessed using an 11-point NRS, where 0 indicates no pain and 10 indicates the worst possible pain, based on data collected in the End of Race Questionnaire (Recovery Zone). Negative values indicate a reduction in pain.
Measured: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone) Questionnaire
Secondary outcomes (17)
Mean Change in Post-Application Pain Score after application of topically applied menthol reported within 60 seconds (Gel and Roll-On).
Mean change in post-application pain score, based on pre-application and post-application NRS assessments (reported within 60 seconds after application) for topical menthol gel and roll-on formats. Pain intensity will be assessed using an 11-point NRS, where 0 indicates no pain and 10 indicates the worst possible pain, based on data collected in the End of Race Questionnaire (Recovery Zone). Negative values indicate a reduction in pain.
Measured: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone) Questionnaire
Proportion of Participants Achieving a Clinically Meaningful Reduction in NRS Pain Score within 60 seconds of topically applied menthol application (Gel and Roll-On).
Proportion of participants who report pain reduction within 60 seconds of topical menthol application, based on pre-application and post-application NRS assessments collected in the End of Race Questionnaire (Recovery Zone). Pain intensity will be assessed using an 11-point Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain. Responders are defined as participants who achieve either a reduction of ≥2 points on the NRS or a ≥30% improvement from baseline.
Measured: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone)
Percentage of Participants Reporting a Cooling Sensation after topically applied menthol use (Gel and Roll-On)
Percentage of participants reporting a cooling sensation following application of topical menthol, based on data collected in the End of Race Questionnaire (Recovery Zone). The outcome measure is the percentage of participants who selected "A cooling sensation".
Measured: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone) Questionnaire
Percentage of Participants Reporting Onset of Cooling Sensation Within 60 Seconds after topically applied menthol use (Gel and Roll-On)
Among participants reporting a cooling sensation following application of topical menthol, the outcome measure is the percentage selecting "Less than 60 seconds/Immediately after application, based on data collected in the End of Race Questionnaire (Recovery Zone)
Measured: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone) Questionnaire
Mean Rating of Cooling Sensation Intensity from the use of topically applied menthol when used after the marathon (Gel and Roll-On)
Among participants reporting a cooling sensation, cooling sensation intensity will be assessed. Participants will rate the intensity on a 10-point scale where 1 indicates a mild cooling sensation and 10 indicates an extremely intense cooling sensation.
Measured: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone) Questionnaire
Mean Rating of Overall Liking of Cooling Sensation from the use of topically applied menthol when used after the marathon (Gel and Roll-On)
Among participants reporting a cooling sensation, overall liking of the cooling sensation will be assessed. Participants will rate their overall liking on a 10-point scale where 1 indicates dislike extremely and 10 indicates like extremely.
Measured: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone) Questionnaire.
Percentage of Participants reporting that the cooling sensation from topically applied menthol helped to reduce pain (Gel and Roll-On)
Among participants reporting a cooling sensation, participants will be asked whether the cooling sensation helped reduce pain. The outcome measure is the percentage of participants responding "Yes".
Measured: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone) Questionnaire.
Proportion of Participants Agreement With Pain Relief and Performance Statements when topically applied menthol was applied During the Race (all formats)
Agreement with statements related to pain relief and performance when topical menthol applied during the race will be assessed using the Post-Race Questionnaire on a 5-point Likert scale, where 1 indicates Strongly Disagree and 5 indicates Strongly Agree. The outcome measure is the proportion of participants selecting 4 (Agree) or 5 (Strongly Agree) for the following statements:
- BioFreeze relieves pain.
- The cooling sensation evoked by BioFreeze reduces pain.
- BioFreeze use during the marathon helped me to run/walk to the finish line by relieving my pain.
- Using BioFreeze during the marathon has provided cooling pain relief that helped me get back in the race.
- Using BioFreeze provided cooling pain relief that helped me keep moving.
Measured: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026
Proportion of participants reporting ≥2-point reduction in pain score following application of topically applied menthol During the Race (all formats)
Proportion of participants reporting a reduction of at least 2 points in pain score or a 30% improvement from baseline following application of topically applied menthol during the race, assessed using an 11-point Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
Measured: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026.
Mean Change in Post-Application Pain Score following application of topically applied menthol During the Race (all formats)
Pain score will be assessed using an 11-point Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain. Mean change in pain score following use of topical menthol during the race will be calculated as the post-application pain score minus the pre-application pain score. Negative values indicate a reduction in pain.
Measured: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026.
Proportion of Participants Agreement With Pain Relief and Performance Statements when topically applied menthol was applied After the Race (all formats)
Agreement with statements related to pain relief and performance when topical menthol applied after the race will be assessed using the Post-Race Questionnaire on a 5-point Likert scale, where 1 indicates Strongly Disagree and 5 indicates Strongly Agree. The outcome measure is the proportion of participants selecting 4 (Agree) or 5 (Strongly Agree) for the following statements:
- BioFreeze relieves pain.
- The cooling sensation from BioFreeze reduces pain.
- Using BioFreeze provided cooling pain relief that has helped me keep moving
Measured: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026.
Mean Change in Post-Application Pain Score following application of topically applied menthol After the Race (Professional Range Gel, UltraFlex Plus Patch and Aerosol Spray).
Pain score will be assessed using an 11-point Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain. Mean change in pain score following use of topical menthol after completion of the marathon will be calculated as the post-application pain score minus the pre-application pain score. Negative values indicate a reduction in pain.
Measured: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026.
Percentage of Participants Reporting Pain Relief Lasting Two Hours or More when topically applied menthol is applied after the race (all formats).
Pain relief duration following use of topical menthol after the race will be assessed using the Post-Race Questionnaire. The outcome measure is the percentage of participants reporting that pain relief lasted for 2 hours or more following application of topical menthol. Participants will respond to a single-select question regarding how long they believe topical menthol provided pain relief, selecting one of the following response options:
- Less than 30 minutes
- 30 minutes to less than 60 minutes
- 60 minutes to less than 2 hours
- 2 hours to less than 3 hours
- 3 hours to less than 4 hours
- 4 hours to less than 5 hours
- 5 hours to less than 8 hours
- 8 hours or more
Measured: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026.
Proportion of Participants Reporting Agreement With Pain Relief and Recovery Statements when topically applied menthol is applied after the race (all formats).
Agreement with statements related to pain relief and recovery following use of topical menthol after the race will be assessed using the Post-Race Questionnaire on a 5-point Likert scale, where 1 indicates Strongly Disagree and 5 indicates Strongly Agree. The outcome measure is the proportion of participants selecting 4 (Agree) or 5 (Strongly Agree) for the following statements:
- The pain relief provided by BioFreeze improved my recovery.
- Using BioFreeze during my recovery helped me keep moving after the race. 3 )BioFreeze has supported my post-race recovery.
- I trust BioFreeze for my post-race recovery and pain relief. 5) BioFreeze provides cooling pain relief that supports my active lifestyle. 6) BioFreeze provides soothing pain relief for life on the go.
Measured: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026.
Proportion of Participants Reporting Likelihood to Recommend Topically Applied Menthol to Other Runners During Marathons
Likelihood of recommending topical menthol to other runners during marathons will be assessed using the Post-Race Questionnaire. Participants will select a single response from the following options:
- Very likely
- Likely
- Neutral
- Unlikely
- Very unlikely The outcome measure is the proportion of participants selecting "Likely" or "Very likely".
Measured: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026.
Proportion of Participants Reporting Likelihood to Recommend Topically Applied Menthol to Other Runners for Post-Race Recovery
Likelihood of recommending topical menthol to other runners for post-race recovery will be assessed using the Post-Race Questionnaire. Participants will select a single response from the following options:
- Very unlikely
- Unlikely
- Neutral
- Likely
- Very likely
- Not applicable, did not use topical menthol during recovery The outcome measure is the proportion of participants selecting "Likely" or "Very likely".
Measured: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026.
Proportion of Participants Reporting Agreement With Sleep Quality Statements After the Race
Agreement with statements related to sleep quality following use of topically applied menthol after the race will be assessed using the Post-Race Questionnaire on a 5-point Likert scale, where 1 indicates Strongly Disagree and 5 indicates Strongly Agree. The outcome measure is the proportion of participants selecting 4 (Agree) or 5 (Strongly Agree) for the following statements:
- The pain relief from BioFreeze helped me get to sleep.
- BioFreezerelieved my pain to help me get a good night's sleep.
Measured: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start11 Oct 2026 (estimated)
- Primary completion13 Oct 2026 (estimated)
- Study completion13 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SorenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873242
- Sponsor's protocol ID
- 5106902
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 16 Oct 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Evidence Study to Evaluate the Analgesic Properties of Topically Applied Menthol and Its Impact on Quality of Life in Marathon Participants
- ClinicalTrials.gov ID
- NCT07873242
- Acronym / sponsor ID
- 5106902
- Conditions
- Muscle Soreness
- Keywords
- Biofreeze, Topical-applied menthol
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2026 (estimated)
- Primary completion
- 13 Oct 2026 (estimated)
- Study completion
- 13 Oct 2026 (estimated)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the research study is to better understand the factors that impact pain experience in adult (18+ years) marathon runners participating in the 2026 Chicago Marathon and to better understand if topically applied menthol provides effective pain relief and impacts quality-of-life outcomes when used during the marathon, in the Recovery Zone immediately after the marathon, or during post-race recovery.
The main questions the study aims to answer are:
- Does topically applied menthol (gel and roll-on formats) reduce pain when applied in the Recovery Zone immediately after a marathon?
- What are the sensory attributes (e.g., cooling sensation) of topically applied menthol (gel and roll-on) when used in the Recovery Zone immediately after a marathon?
- How do participants assess the effects of topically applied menthol products used during and/or after a marathon on pain relief, performance, recovery, and sleep-related quality-of-life outcomes? Researchers will evaluate participant-reported pre- and post-application pain scores in the Recovery Zone immediately following the marathon and post-race outcomes to assess analgesic effectiveness, sensory attributes, and quality-of-life outcomes associated with Biofreeze use.
Participants will:
- Provide documented informed consent prior to participation.
- Self-select to use Biofreeze products during and/or after the race.
- Complete one or both of the following:
- End of Race Questionnaire (includes pain score before and after Biofreeze application, sensory assessments, and demographics).
- Post-Race Questionnaire (includes retrospective recall of pain relief, product use, sensory experience, sleep-related outcomes and demographic data).
Detailed description
This observational, real-world evidence study will evaluate pain relief, sensory attributes, and quality-of-life outcomes among adult (18+ years) runners participating in the 2026 Chicago Marathon who independently choose to use Biofreeze at the end of the marathon in the Recovery Zone, or after the race.
Biofreeze products are available to runners irrespective of study participation, and participants independently decide whether to use Biofreeze and which product format to use.
The study will collect information through two questionnaires: End of Race Questionnaire completed in the Recovery Zone immediately following the marathon and Post-Race Questionnaire completed after the race. Data collected through the two questionnaires will not be linked. Participants will provide separate informed consent before completing each questionnaire.
For the End of Race Questionnaire, runners who independently enter the Recovery Zone and choose to use Biofreeze will be invited to participate. After providing informed consent, participants will report their pain intensity before applying their selected Biofreeze product and after application using a Numerical Rating Scale (NRS). Information on product format, pain location, cooling sensation and related sensory attributes, and demographic characteristics will also be collected.
The primary evaluation will assess the analgesic effect of topically applied menthol gel and roll-on formulations in the Recovery Zone, based on changes in participant-reported NRS pain scores.
Secondary evaluations will assess clinically meaningful reduction in pain, sensory attributes associated with product use, sensory attributes, pain-relieving effects of Biofreeze used during and/or after the marathon, and recovery- and sleep-related quality-of-life outcomes.
The Post-Race Questionnaire will collect participant-reported information on Biofreeze use during and/or after the marathon, including pain relief, sensory attributes, duration of pain relief, and perceived effects on performance, recovery, and sleep-related outcomes, as well as demographic characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chicago Marathon Runners who use topically applied menthol | – | Other: Observational, Other: Non-Interventional StudyChicago Marathon Runners over 18 years who use topically applied menthol during and after the race |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will recruit runners over 18 years old, participating in the 2026 Chicago Marathon, capable of providing documented informed consent, who are not employees of Reckitt or the vendor collecting data.
Key inclusion criteria (5 listed)
- Participant has provided documented informed consent.
- Participant aged 18 years and above.
- Participant is an entrant into the Chicago marathon 2026.
- Participant has self-selected to use Biofreeze during the race or during immediate recovery.
- Comprehension of and able to read English.
Key exclusion criteria (1 listed)
- 1. Employee of Sponsor or Agency/ vendor collecting the data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalPain-experience observational study conducted during and after a marathon. | Other | Chicago Marathon Runners who use topically applied menthol |
| Non-Interventional StudyNon-Interventional Study | Other | Chicago Marathon Runners who use topically applied menthol |
Primary outcome
Mean Change in Post-Application Pain Score (Gel Format)
Time frame: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone) Questionnaire
Mean change in post-application pain score, based on pre-application NRS and post-application NRS when topical menthol gel is applied after the race. Pain intensity will be assessed using an 11-point NRS, where 0 indicates no pain and 10 indicates the worst possible pain, based on data collected in the End of Race Questionnaire (Recovery Zone). Negative values indicate a reduction in pain.
Mean Change in Post-Application Pain Score (Roll-On Format)
Time frame: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone) Questionnaire
Mean change in post-application pain score, based on pre-application NRS and post-application NRS when topical menthol roll-on is applied after the race. Pain intensity will be assessed using an 11-point NRS, where 0 indicates no pain and 10 indicates the worst possible pain, based on data collected in the End of Race Questionnaire (Recovery Zone). Negative values indicate a reduction in pain.
17 secondary outcomes
Mean Change in Post-Application Pain Score after application of topically applied menthol reported within 60 seconds (Gel and Roll-On).
Time frame: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone) Questionnaire
Proportion of Participants Achieving a Clinically Meaningful Reduction in NRS Pain Score within 60 seconds of topically applied menthol application (Gel and Roll-On).
Time frame: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone)
Percentage of Participants Reporting a Cooling Sensation after topically applied menthol use (Gel and Roll-On)
Time frame: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone) Questionnaire
Percentage of Participants Reporting Onset of Cooling Sensation Within 60 Seconds after topically applied menthol use (Gel and Roll-On)
Time frame: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone) Questionnaire
Mean Rating of Cooling Sensation Intensity from the use of topically applied menthol when used after the marathon (Gel and Roll-On)
Time frame: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone) Questionnaire
Mean Rating of Overall Liking of Cooling Sensation from the use of topically applied menthol when used after the marathon (Gel and Roll-On)
Time frame: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone) Questionnaire.
Percentage of Participants reporting that the cooling sensation from topically applied menthol helped to reduce pain (Gel and Roll-On)
Time frame: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone) Questionnaire.
Proportion of Participants Agreement With Pain Relief and Performance Statements when topically applied menthol was applied During the Race (all formats)
Time frame: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026
Proportion of participants reporting ≥2-point reduction in pain score following application of topically applied menthol During the Race (all formats)
Time frame: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026.
Mean Change in Post-Application Pain Score following application of topically applied menthol During the Race (all formats)
Time frame: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026.
Proportion of Participants Agreement With Pain Relief and Performance Statements when topically applied menthol was applied After the Race (all formats)
Time frame: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026.
Mean Change in Post-Application Pain Score following application of topically applied menthol After the Race (Professional Range Gel, UltraFlex Plus Patch and Aerosol Spray).
Time frame: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026.
Percentage of Participants Reporting Pain Relief Lasting Two Hours or More when topically applied menthol is applied after the race (all formats).
Time frame: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026.
Proportion of Participants Reporting Agreement With Pain Relief and Recovery Statements when topically applied menthol is applied after the race (all formats).
Time frame: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026.
Proportion of Participants Reporting Likelihood to Recommend Topically Applied Menthol to Other Runners During Marathons
Time frame: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026.
Proportion of Participants Reporting Likelihood to Recommend Topically Applied Menthol to Other Runners for Post-Race Recovery
Time frame: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026.
Proportion of Participants Reporting Agreement With Sleep Quality Statements After the Race
Time frame: Retrospective recall data from the Post-Race Questionnaire will be completed on Day 2 to Day 3 within 48 hours after race day: Completed from 6am on Day 2, 12-Oct-2026 up to 23:59 on Day 3, 13-Oct-2026.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. IPD is completely anonymised and each participant can no longer be identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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: opening soon, as of the sponsor's last update on 16 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice Allen (+447710783342, alice.allen@reckitt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Post-Application Pain Score (Gel Format) (time frame: Day 1 - immediately at the end of the race, assessed within the End of Race (Recovery Zone) Questionnaire). The study lists 2 primary outcomes in all. 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 16 Oct 2026.