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

NCT06771076 | Completed

• 1 other identifier: CBDTRI001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tendinopathy; Injuries; Chronic Pain; Sports; Physical Activity

Keywords

CBD; Cannabidiol; Triathlon; Chronic injuries; Running; Cycling; Swimming

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Effect of the cream on wellness

  Through the two 1-month intervention periods.

• Effect of the cream on the perceived exertion

  Through the two 1-month intervention periods.

• Effect of the cream on the quality of life

  After the two 1-month intervention periods.

• Treatment assessment

  After the two 1-month intervention periods.

Study Arms (2)

Cream with CBD and natural ingredients - Cream without CBD and natural ingredients

EXPERIMENTAL

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; Other: Cream without CBD and natural ingredients

Cream without CBD and natural ingredients - Cream with CBD and natural ingredients

EXPERIMENTAL

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; Other: Cream without CBD and natural ingredients

Interventions

Cream with CBD and natural ingredients OTHER

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).

Also known as: Cream with CBD

Cream with CBD and natural ingredients - Cream without CBD and natural ingredients; Cream without CBD and natural ingredients - Cream with CBD and natural ingredients

Cream without CBD and natural ingredients OTHER

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).

Also known as: Cream without CBD

Cream with CBD and natural ingredients - Cream without CBD and natural ingredients; Cream without CBD and natural ingredients - Cream with CBD and natural ingredients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead
• Uriach Consumer Healthcare: collaborator

Study Sites (1)

University of Vic - Central University of Catalonia

Vic, Barcelona, 08500, Spain

Location

Related Publications (5)

• 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.

  PMID: 32060142 BACKGROUND

• 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.

  PMID: 30211382 BACKGROUND

• 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.

  PMID: 20861526 BACKGROUND

• Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

  PMID: 7154893 BACKGROUND

• 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.

  PMID: 9626712 BACKGROUND

MeSH Terms

Conditions

Tendinopathy; Wounds and Injuries; Chronic Pain; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Javier Peña López, Ph.D.

  Sport, Exercise, and Human Movement (SEaHM), University of Vic - Central University of Catalonia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both creams will have identical containers (a neutral white tube), with the only difference being that they will be tagged with the letter "A" or "B" (without any additional information on any part of the container).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will have two periods of one month in which they will use different creams, one containing CBD and natural ingredients, while the other will not. The cream not used during the first month will be the used one in the second month. These periods will be separated by a one-week wash-out.

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 13, 2025
• Study Start: January 18, 2025
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)