An observational study in Muscle Soreness, sponsored by Reckitt Benckiser Healthcare (UK) Limited. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Reckitt Benckiser Healthcare (UK) Limited (part of Reckitt) · Observational
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:
Participants will:
Complete one or both of the following:
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.
288 studies on the registry are indexed under Myalgia; 46 are open to participants now.
This study's planned enrollment of 600 is above the median of 154 across 37 observational studies indexed under Myalgia.
Browse Myalgia studies →Reckitt Benckiser Healthcare (UK) Limited is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1. Employee of Sponsor or Agency/ vendor collecting the data
Chicago Marathon Runners over 18 years who use topically applied menthol during and after the race
Other: Observational · Other: Non-Interventional Study
Pain-experience observational study conducted during and after a marathon.
Non-Interventional Study
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.
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 (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.
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 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.
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).
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.
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)
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".
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)
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)
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)
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.
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)
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.
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)
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".
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)
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: 1. BioFreeze relieves pain. 2. The cooling sensation evoked by BioFreeze reduces pain. 3. BioFreeze use during the marathon helped me to run/walk to the finish line by relieving my pain. 4. Using BioFreeze during the marathon has provided cooling pain relief that helped me get back in the race. 5. Using BioFreeze provided cooling pain relief that helped me keep moving.
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)
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.
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)
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.
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)
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: 1. BioFreeze relieves pain. 2. The cooling sensation from BioFreeze reduces pain. 3. Using BioFreeze provided cooling pain relief that has helped me keep moving
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).
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.
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).
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
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).
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: 1. The pain relief provided by BioFreeze improved my recovery. 2. Using BioFreeze during my recovery helped me keep moving after the race. 3 )BioFreeze has supported my post-race recovery. 4\) 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.
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
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".
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
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".
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
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: 1. The pain relief from BioFreeze helped me get to sleep. 2. BioFreezerelieved my pain to help me get a good night's sleep.
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.
Plan to share: No — IPD is completely anonymised and each participant can no longer be identified.
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