Effects of a CBD and Natural Ingredients Cream on the Chronic Pain of Triathletes, Runners, Cyclists, and Swimmers

Assessment of the Effect of a Cosmetic Cream With CBD and Natural Ingredients on the Recurring Chronic Tendon Pain in Triathletes, Runners, Cyclists, and Swimmers: a Randomized, Crossover, Placebo-controlled, Double-blind Trial

There is a high prevalence of chronic pain in our society, which is detrimental at an individual and country level. Cannabidiol (CBD) has been proposed as a promising treatment for chronic pain, although more high-quality studies are needed in this area. On the other hand, triathlon, running, cycling, and swimming are sports modalities that have an increasing professionalism and importance, albeit not exempt from injuries.

The main goal of this study is to assess the effectiveness of a topical treatment for recurrent chronic pain caused by tendinopathies with a cream containing CBD in triathletes, runners, cyclists, and swimmers. Consequently, the research question for this study is the following: Can the CBD cream be effective in treating chronic pain? The investigators hypothesize that the cream will be able to affect the pain, both in the short and the long term.

The study will be interventional, with a crossover, randomized, and double-blinded design. Two groups of participants will be generated, as well as two treatment options (CBD cream, and a similar one without the CBD). The subjects will apply one of the treatments for one month, followed by a wash-out week without any cream application, and another month with the other treatment. During these weeks, different parameters will be controlled via online questionnaires.

The analyzed variables will include the following: Chronic pain, acute pain, wellness, perceived exertion, quality of life, and satisfaction with the treatment. Different statistical tests will be applied to the collected data, comparing their means and correlations to infer the results.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Physical Activity; Tendinopathy; Injuries; Sports
• Intervention / Treatment: Other: Cream with CBD and natural ingredients; Other: Cream without CBD and natural ingredients

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Vic, Barcelona, Spain, 08500
      • University of Vic - Central University of Catalonia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being a federated triathlete, runner, cyclist, or swimmer.
• Being 18-70 years old.
• Having chronic pain (present at least 3 months before the beginning of the study).
• Having a diagnosis of patellar, Achilles, or iliotibial band tendinopathy for the lower extremities, and/or shoulder rotator cuff or biceps brachii tendinopathy for the upper extremities.
• Training any modality of triathlon, running, cycling, or swimming 4-5 days per week with a minimal training volume of 8 hours per week.
• Having at least 1 year of experience training in triathlon, running, cycling, or swimming.
• Providing at least 80% of the needed data for the study.

Exclusion Criteria:

• Pregnant women.
• People allergic to any of the ingredients of the creams used.
• People with skin injuries in the zones in which the cream has to be applied.
• Using any other pain treatments. Those who use them before the study can still participate if they stop their usage 1 week before the beginning of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cream with CBD and natural ingredients - Cream without CBD and natural ingredients; During the first month participants will use the cream with CBD and natural ingredients, and during the second month, the cream without CBD and natural ingredients.	Other: Cream with CBD and natural ingredients; Topical application of the cream with CBD and natural ingredients on the injured areas, twice per day (after waking up, and before going to bed). A crossover with the other intervention will be done in the next/previous month (depending on the arm).; Other Names: Cream with CBD; Other: Cream without CBD and natural ingredients; Topical application of the cream without CBD and natural ingredients on the injured areas, twice per day (after waking up and before going to bed). A crossover with the other intervention will be done in the next/previous month (depending on the arm).; Other Names: Cream without CBD
Experimental: Cream without CBD and natural ingredients - Cream with CBD and natural ingredients; During the first month participants will use the cream without CBD and natural ingredients, and during the second month, the cream with CBD and natural ingredients.	Other: Cream with CBD and natural ingredients; Topical application of the cream with CBD and natural ingredients on the injured areas, twice per day (after waking up, and before going to bed). A crossover with the other intervention will be done in the next/previous month (depending on the arm).; Other Names: Cream with CBD; Other: Cream without CBD and natural ingredients; Topical application of the cream without CBD and natural ingredients on the injured areas, twice per day (after waking up and before going to bed). A crossover with the other intervention will be done in the next/previous month (depending on the arm).; Other Names: Cream without CBD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic effect of the cream	Assessment of the pain in the affected zone/s. The measurement will be done once per week (Fridays at night). Assessed using the Oslo Sports Trauma Research Center Overuse Injury Questionnaire (metric: answers to the questions of the instrument).	Through the two 1-month intervention periods.
Acute effect of the cream	Assessment of the pain in the affected zone/s. The measurement will be done twice per day before applying the cream (after waking up and before going to bed). Besides, the first time the creams are used, the questionnaire will be answered after 5, 10, 15, and 30 minutes. Assessed using a Visual Analog Scale (metric: answer to the question of the instrument). This scale is answered by moving a slider through a line until the desired number is reached, ranging from 0 to 10. Higher scores mean more pain (a worse outcome).	Through the two 1-month intervention periods.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of the cream on wellness	Assessment of the wellness of the participants on competition day. The measurement will be done before applying the cream, after waking up. Assessed using a preexisting questionnaire (metric: answers to the questions of the instrument).	Through the two 1-month intervention periods.
Effect of the cream on the perceived exertion	Assessment of the perceived exertion of the participants after competing. The measurement will be done during the first 15-20 minutes after the competition. Assessed using a Borg scale (metric: answer to the question of the instrument). This scale is answered with a number ranging from 0 to 10. Higher scores mean more exertion (a worse outcome).	Through the two 1-month intervention periods.
Effect of the cream on the quality of life	Assessment of the quality of life of the participants after the treatment. The measurement will be done during the morning of the day after each treatment period has finished. Assessed using specific questions of the World Health Organization Quality of Life-BREF questionnaire (metric: answers to the questions of the instrument). These questions are answered with a number ranging from 1 to 5. Depending on the question, a lower or a higher score may be a worse outcome.	After the two 1-month intervention periods.
Treatment assessment	Assessment of the organoleptic characteristics and the satisfaction with the treatment. The measurement will be done during the morning of the day after each treatment period has finished. Assessed using ad-hoc questionnaires (metric: answers to the questions of the instrument).	After the two 1-month intervention periods.

Collaborators and Investigators

• Sponsor: University of Vic - Central University of Catalonia
• Collaborators: Uriach Consumer Healthcare
• Investigators: Principal Investigator: Javier Peña López, Ph.D., Sport, Exercise, and Human Movement (SEaHM), University of Vic - Central University of Catalonia

Publications and helpful links

General Publications

• Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
• Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
• Clarsen B, Bahr R, Myklebust G, Andersson SH, Docking SI, Drew M, Finch CF, Fortington LV, Haroy J, Khan KM, Moreau B, Moore IS, Moller M, Nabhan D, Nielsen RO, Pasanen K, Schwellnus M, Soligard T, Verhagen E. Improved reporting of overuse injuries and health problems in sport: an update of the Oslo Sport Trauma Research Center questionnaires. Br J Sports Med. 2020 Apr;54(7):390-396. doi: 10.1136/bjsports-2019-101337. Epub 2020 Feb 14.
• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
• McLean BD, Coutts AJ, Kelly V, McGuigan MR, Cormack SJ. Neuromuscular, endocrine, and perceptual fatigue responses during different length between-match microcycles in professional rugby league players. Int J Sports Physiol Perform. 2010 Sep;5(3):367-83. doi: 10.1123/ijspp.5.3.367.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2025
• Primary Completion (Actual): May 16, 2025
• Study Completion (Actual): May 16, 2025

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Cycling; CBD; Running; Cannabidiol; Triathlon; Swimming; Chronic injuries
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Chronic Pain; Tendinopathy
• Other Study ID Numbers: CBDTRI001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No