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NCT Number: NCT06771076

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

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.

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Key information

Conditions

Tendinopathy Behavior Chronic Pain Injuries Motor Activity Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms Sports Tendon Injuries Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vic - Central University of Catalonia

Vic, Barcelona, 08500, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: Cream with CBD

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).

Other names: Cream without CBD

Primary outcomes

  1. Chronic effect of the cream

    Time frame: Through the two 1-month intervention periods.

    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).

  2. Acute effect of the cream

    Time frame: Through the two 1-month intervention periods.

    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).

Secondary outcomes

  1. Effect of the cream on wellness

    Time frame: Through the two 1-month intervention periods.

    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).

  2. Effect of the cream on the perceived exertion

    Time frame: Through the two 1-month intervention periods.

    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).

  3. Effect of the cream on the quality of life

    Time frame: After the two 1-month intervention periods.

    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.

  4. Treatment assessment

    Time frame: After the two 1-month intervention periods.

    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).

Sponsors and collaborators

Lead sponsor

University of Vic - Central University of Catalonia

Other

Collaborators

  • Uriach Consumer Healthcare

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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