Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06320327
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2024-03-13
Brief Title:
Topical CBDs Effects on Soreness and Performance
Sponsor:
Joseph Pastina
Organization:
University of Kentucky
Study Overview
Official Title:
The Effects of Cannabidiol CBD Cream on Delayed Onset Muscle Soreness DOMS and Performance After Exercise
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 studys 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
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 studys 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
Detailed Description:
This study is a randomized double-blind placebo-controlled experiment examining if CBD cream impacts recovery after exercise It will be investigated whether or not the potential effects of CBD cream are localized or systemic within the lower body muscles quadriceps and hamstrings Furthermore the study will examine if these potential effects on recovery impact the expected decrements on lower body performance in the days following an intense exercise bout Overall the main objective is to determine whether or not CBD cream is an effective recovery method for those who are experiencing DOMS
Participants will be recruited from volunteers who reside in the Lexington area Those who participate within the study will be randomly placed into one of three groups by the PI Dr Stuart Best a group that will apply the CBD cream Group 1 a group that will apply the placebo moisturizer cream Group 2 or a control group that does not participate in any cream-related procedures Group 3
The research participants and research personnel conducting the testing will be blinded to who is in the CBD and placebo groups throughout the study Furthermore the PI who will not participate in any form of testing will also be responsible for the storage and distribution of the CBD and placebo creams during 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
A summary of the participant groups is shown below
Group 1 - CBD Group This group will apply the CBD cream in accordance with the manufacturers recommendations throughout the study Application procedures are described in a section below
Group 2 - Placebo Group This group will apply a placebo moisturizer cream that will match the scent volume and viscosity of the CBD cream Application procedures are described in a section below
Group 3 - Control Group This group will not apply any cream and will skip all cream-related procedures during the study During the time that would be designated for cream-related procedures the control group will rest this rest period will match the durations of the cream-related procedures for Groups 1 and 2 to keep the delivery of procedures as controlled as possible between groups
Participants will complete five sessions over the span of 7-11 days Sessions 1 and 2 will be separated by 3-7 days to wash-out any potential soreness from baseline testing and Sessions 2-5 will be separated by 24-hr each A session outline is described below
Session 1 Anthropometric data baseline measurements for isokinetic peak torque PT and countermovement jump CMJ as well as familiarization with the pressure-pain threshold PPT test are established Prior to baseline testing familiarization with the CMJ and PT instruments and procedures are included during this introductory session
Session 2 3-7 days after Session 1 The time between Sessions 1 and 2 ensured each participant began the Session 2 without any residual muscle damage or soreness from Session 1 Participants will complete a digital questionnaire to monitor and evaluate soreness and recovery Questionnaires will be administered using Research Electronic Data Capture REDCap on the investigators personal computer Participants will then complete a PPT test which will serve as their baseline measurement followed by a fatiguing exercise protocol FP designed to induce muscle damage and soreness The FP consists of repeated maximal effort concentric and eccentric muscle actions at the knee joint 5 sets 10 reps 30 seconds rest for both concentriceccentric knee extensionflexion and eccentricconcentric knee extensionflexion respectively A Post-FP questionnaire will be completed to monitor changes in muscle soreness after the FP followed by the cream applicationsitting rest procedures CR for each participants respective group The session concludes with a questionnaire Post CR to evaluate the effects of creamrest another PPT and a CMJ assessment
Session 3 and 4 24- and 48-hr after Session 2 Sessions 3 and 4 will utilize identical procedures Participants will complete a Pre-Session questionnaire to monitor soreness and recovery Then PPT and CMJ tests are completed Participants then apply cream or have seated rest according to the respective protocol for their group After the cream applicationsitting procedure occur participants complete a follow-up Post CR questionnaire Lastly PPT and CMJ are completed again by the participant
Session 5 72-hr after Session 2 Session 5 repeats the research procedures of Session 1 with the exclusion of anthropometric testing To complete Session 5 as well as their participation in the study each participant will complete a Post-Study questionnaire
Application Procedures
Cream application procedures will be the same for both CBD and placebo groups with only the type of cream applied differing between the two groups Participants will have their quadriceps marked to represent a cream application zone Similar to the quadriceps PPT the markings made on the midline of the anterior leg midway between the anterior superior iliac spine ASIS and the superior border of the patella will be utilized However two new markings will be created to serve as a superior and inferior site 1 being one-third of the distance between the ASIS and the superior border of the patella and 2 two-thirds of the distance between the ASIS and the superior border of the patella Each participant will first apply the cream to the most superior site on the dominant leg in a clockwise rhythm at a standardized cadence 50 beatsmin-1 for 30 seconds The participant will then be instructed to proceed inferiorly until all three sites are completed For each site participants will be instructed to apply approximately one-third of the total quantity of cream per container At the conclusion of this process participants will be told to finish applying any residual cream remaining in the containers across the entire area of cream application To assess the localized vs systemic effects of CBD cream cream will only be applied to the quadriceps in both the CBD and placebo groups Participants within the control group will be instructed to sit in a relaxed position for 3 minutes This duration has been chosen because it matches the total time of the cream application for CBD and placebo groups
Participants will be recruited from volunteers who reside in the Lexington area Those who participate within the study will be randomly placed into one of three groups by the PI Dr Stuart Best a group that will apply the CBD cream Group 1 a group that will apply the placebo moisturizer cream Group 2 or a control group that does not participate in any cream-related procedures Group 3
The research participants and research personnel conducting the testing will be blinded to who is in the CBD and placebo groups throughout the study Furthermore the PI who will not participate in any form of testing will also be responsible for the storage and distribution of the CBD and placebo creams during 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
A summary of the participant groups is shown below
Group 1 - CBD Group This group will apply the CBD cream in accordance with the manufacturers recommendations throughout the study Application procedures are described in a section below
Group 2 - Placebo Group This group will apply a placebo moisturizer cream that will match the scent volume and viscosity of the CBD cream Application procedures are described in a section below
Group 3 - Control Group This group will not apply any cream and will skip all cream-related procedures during the study During the time that would be designated for cream-related procedures the control group will rest this rest period will match the durations of the cream-related procedures for Groups 1 and 2 to keep the delivery of procedures as controlled as possible between groups
Participants will complete five sessions over the span of 7-11 days Sessions 1 and 2 will be separated by 3-7 days to wash-out any potential soreness from baseline testing and Sessions 2-5 will be separated by 24-hr each A session outline is described below
Session 1 Anthropometric data baseline measurements for isokinetic peak torque PT and countermovement jump CMJ as well as familiarization with the pressure-pain threshold PPT test are established Prior to baseline testing familiarization with the CMJ and PT instruments and procedures are included during this introductory session
Session 2 3-7 days after Session 1 The time between Sessions 1 and 2 ensured each participant began the Session 2 without any residual muscle damage or soreness from Session 1 Participants will complete a digital questionnaire to monitor and evaluate soreness and recovery Questionnaires will be administered using Research Electronic Data Capture REDCap on the investigators personal computer Participants will then complete a PPT test which will serve as their baseline measurement followed by a fatiguing exercise protocol FP designed to induce muscle damage and soreness The FP consists of repeated maximal effort concentric and eccentric muscle actions at the knee joint 5 sets 10 reps 30 seconds rest for both concentriceccentric knee extensionflexion and eccentricconcentric knee extensionflexion respectively A Post-FP questionnaire will be completed to monitor changes in muscle soreness after the FP followed by the cream applicationsitting rest procedures CR for each participants respective group The session concludes with a questionnaire Post CR to evaluate the effects of creamrest another PPT and a CMJ assessment
Session 3 and 4 24- and 48-hr after Session 2 Sessions 3 and 4 will utilize identical procedures Participants will complete a Pre-Session questionnaire to monitor soreness and recovery Then PPT and CMJ tests are completed Participants then apply cream or have seated rest according to the respective protocol for their group After the cream applicationsitting procedure occur participants complete a follow-up Post CR questionnaire Lastly PPT and CMJ are completed again by the participant
Session 5 72-hr after Session 2 Session 5 repeats the research procedures of Session 1 with the exclusion of anthropometric testing To complete Session 5 as well as their participation in the study each participant will complete a Post-Study questionnaire
Application Procedures
Cream application procedures will be the same for both CBD and placebo groups with only the type of cream applied differing between the two groups Participants will have their quadriceps marked to represent a cream application zone Similar to the quadriceps PPT the markings made on the midline of the anterior leg midway between the anterior superior iliac spine ASIS and the superior border of the patella will be utilized However two new markings will be created to serve as a superior and inferior site 1 being one-third of the distance between the ASIS and the superior border of the patella and 2 two-thirds of the distance between the ASIS and the superior border of the patella Each participant will first apply the cream to the most superior site on the dominant leg in a clockwise rhythm at a standardized cadence 50 beatsmin-1 for 30 seconds The participant will then be instructed to proceed inferiorly until all three sites are completed For each site participants will be instructed to apply approximately one-third of the total quantity of cream per container At the conclusion of this process participants will be told to finish applying any residual cream remaining in the containers across the entire area of cream application To assess the localized vs systemic effects of CBD cream cream will only be applied to the quadriceps in both the CBD and placebo groups Participants within the control group will be instructed to sit in a relaxed position for 3 minutes This duration has been chosen because it matches the total time of the cream application for CBD and placebo groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None