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

NCT07565246 | Completed FDA Drug

• 1 other identifier: 5106901
• Study Type: observational
• Target: 367
• Locations: 1 country
• Sites: 1

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:
• Recovery Application Zone Questionnaire (includes pain score before and after Biofreeze application, sensory assessments, demographics).
• End of Race Questionnaire (includes retrospective recall of pain relief, product use, sensory experience, and demographic data).

Conditions

Muscle Soreness

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (17)

• 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.

Study Arms (1)

Chicago Marathon Runners who use topically applied menthol

Other: Observational

Interventions

Observational OTHER

Pain-experience observational study conducted during a marathon.

Chicago Marathon Runners who use topically applied menthol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead

Study Sites (1)

Curion Strategic Product Insights

Deerfield, Illinois, 60015, United States

Location

MeSH Terms

Conditions

Myalgia

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Neeta Yousaf, PHD

  Curion Strategic Product Insights

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: May 4, 2026
• Study Start: October 12, 2025
• Primary Completion: October 12, 2025
• Study Completion: October 12, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)