Topical CBD's Effects on Soreness and Performance

NCT06320327 | Completed

• 1 other identifier: 80177
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Muscle Soreness

Keywords

Exercise; Cannabidiol cream

Outcome Measures

Primary Outcomes (1)

• Vertical Jump Test

  The vertical jump, or countermovement jump (CMJ), test will utilize the ForceDecks Dual Force Plate System by Vald Performance to measure peak force production and vertical jump height (one plate for each leg; sampling frequency = 1,000 Hz).

  Baseline and immediately post exercise, then 24, 48, and 72 hours post-exercise (pre- and post-cream/rest).

Secondary Outcomes (2)

• Peak Isokinetic Torque Test

  Baseline and Session 5 (72 hours post-exercise)

• Pressure-Pain Threshold Test

  Baseline and immediately post exercise, then 24, 48, and 72 hours post-exercise (pre- and post-cream/rest).

Study Arms (3)

CBD Group

EXPERIMENTAL

This group will apply the CBD cream in accordance with the manufacturer's recommendations at designated time points throughout the study.

Other: Cannabidiol cream

Placebo Group

PLACEBO COMPARATOR

This group will apply a placebo moisturizer cream that will match the scent, volume, and viscosity of the CBD cream.

Other: Placebo cream

Control Group

NO INTERVENTION

This group will not apply any cream and will skip all cream-related procedures during the study.

Interventions

Cannabidiol cream OTHER

Group 1 will be administered the recommended quantity of CBD cream to be applied at various times throughout the study and used in a specific way instructed by the researcher (the cream is applied via massage through a standardized application method).

Also known as: Myaderm Advanced RX10 Fast Acting Relief Cream

CBD Group

Placebo cream OTHER

Group 2 will be administered the recommended quantity of placebo cream to be applied at various times throughout the study and used in a specific way instructed by the researcher (the cream is applied via massage through a standardized application method).

Also known as: Gold Bond Diabetics' Dry Skin Relief Lotion

Placebo Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Physically healthy
• Age 18-45
• Available for 5 sessions over the span of 2 weeks
• Untrained (have not been participating in a structured resistance training routine for the past 2 months that includes 2 days of lower body resistance training per week)

You may not qualify if:

• Have not suffered a lower body injury in the previous 3 months
• Be allergic to any ingredients within the CBD or placebo creams (ingredients listed in informed consent form)
• Be pregnant

Sponsors & Collaborators

• Joseph Pastina: lead

Study Sites (2)

Seaton Center Building

Lexington, Kentucky, 40502, United States

Location

Multidisciplinary Science Building

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Myalgia; Motor Activity

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; Behavior

Study Officials

• Stuart A Best, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: August 23, 2022
• Primary Completion: April 27, 2023
• Study Completion: April 30, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

US (2)