Chronic Pain, Injuries, Physical Activity, Sports, Tendinopathy
Conditions
Keywords
CBD, Cannabidiol, Triathlon, Chronic injuries, Running, Cycling, Swimming
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.
Interventions
OTHERCream 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).
OTHERCream 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).
Sponsors
Uriach Consumer Healthcare
University of Vic - Central University of Catalonia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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).
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic effect of the cream | 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). |
| Acute effect of the cream | 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
| Measure | Time frame | Description |
|---|---|---|
| Effect of the cream on wellness | 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). |
| Effect of the cream on the perceived exertion | 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). |
| Effect of the cream on the quality of life | 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. |
| Treatment assessment | 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). |
Countries
Spain
Outcome results
None listed