protocolSection identificationModule nctId: NCT06320327, orgStudyIdInfo id: 80177, briefTitle: Topical CBD's Effects on Soreness and Performance, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-23, primaryCompletionDateStruct date: 2023-04-27, completionDateStruct date: 2023-04-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Joseph Pastina, class: OTHER, descriptionModule briefSummary: Exercise-induced muscle damage (EIMD) results from unaccustomed exercise and can lead to delayed onset muscle soreness (DOMS). Impairments associated with EIMD and DOMS can result in moderate-to-severe discomfort and hindered performance. Recently, a compound derived from the cannabis plant, cannabidiol (CBD), has been used as a recovery tool for EIMD and DOMS. Despite the rising popularity of CBD products, their effectiveness in mitigating EIMD and DOMS is unknown. Specifically, to the investigators' knowledge, no clinical trials have been completed to assess the effects of topical CBD cream application on soreness, recovery and performance.Therefore, the purpose of the present study was to investigate the effects of CBD cream on DOMS and performance after an intensive lower-body exercise protocol. Specifically, the study's aims were:Aim 1: To assess the effect of topical CBD cream administration on muscle soreness following fatiguing exercise.Hypothesis 1: CBD cream would decrease perceived muscle soreness when compared to a placebo or control (no cream) group.Aim 2: To assess the effect of topical CBD cream administration on muscular performance following fatiguing exercise.Hypothesis 2: Recovery of muscular power would be quicker when CBD cream is applied, compared to a placebo or control (no cream) group.Aim 3: To assess if topical CBD cream has a localized (if any) or systemic effect on muscle soreness.Hypothesis 3: Improvements in muscle soreness would only be observed in localized muscles around where the CBD cream was applied., conditionsModule conditions: Muscle Soreness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: The research participant's and research personnel conducting the testing will be blinded to who is in the CBD and placebo groups throughout the study. Those in Group 3 (the control group) will be aware that they are in the control group, as they will be skipping the steps involving cream application. The protocols for Group 1 and Group 2 will be identical and the respective cream will be made available to the testers and participants in identical containers., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Cannabidiol cream, interventions name: Placebo cream, outcomesModule primaryOutcomes measure: Vertical Jump Test, secondaryOutcomes measure: Peak Isokinetic Torque Test, secondaryOutcomes measure: Pressure-Pain Threshold Test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Seaton Center Building, city: Lexington, state: Kentucky, zip: 40502, country: United States, geoPoint lat: 37.98869, lon: -84.47772, locations facility: Multidisciplinary Science Building, city: Lexington, state: Kentucky, zip: 40536, country: United States, geoPoint lat: 37.98869, lon: -84.47772, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2022-08-04, uploadDate: 2024-03-13T17:59, filename: ICF_000.pdf, size: 187622, hasResults: False