Clinical trial NCT06771076: Effects of a CBD and Natural Ingredients Cream on the Chronic Pain of Triathletes, Runners, Cyclists, and Swimmers
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendinopathy
Injuries
Chronic Pain
Sports
Physical Activity
Keywords: CBD
Cannabidiol
Triathlon
Chronic injuries
Running
Cycling
Swimming
Lead sponsor: University of Vic - Central University of Catalonia
Sponsor class: OTHER
Collaborators: name: Uriach Consumer Healthcare
First posted: 2025-01-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Chronic effect of the cream
timeFrame: Through the two 1-month intervention periods.
measure: Acute effect of the cream
timeFrame: Through the two 1-month intervention periods.
Secondary outcomes:
measure: Effect of the cream on wellness
timeFrame: Through the two 1-month intervention periods.
measure: Effect of the cream on the perceived exertion
timeFrame: Through the two 1-month intervention periods.
measure: Effect of the cream on the quality of life
timeFrame: After the two 1-month intervention periods.
measure: Treatment assessment
timeFrame: After the two 1-month intervention periods.
Other outcomes:
Locations:
city: Vic
country: Spain
facility: University of Vic - Central University of Catalonia
state: Barcelona
Study officials:
affiliation: Sport, Exercise, and Human Movement (SEaHM), University of Vic - Central University of Catalonia
name: Javier Peña López, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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