TendinopathyNCT06771076
Effects of a CBD and Natural Ingredients Cream on the Chronic Pain of Triathletes, Runners, Cyclists, and Swimmers
A study testing Cream with CBD and natural ingredients and Cream without CBD and natural ingredients in people with Tendinopathy and Injuries, run by University of Vic - Central University of Catalonia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tendinopathy, Injuries, Chronic Pain
- What is being tested?
- Cream with CBD and natural ingredients and Cream without CBD and natural ingredients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jan 2025to 16 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Vic - Central University of Catalonia
Vic, Barcelona, 08500
About this study
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
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.
Read more
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
- Being tested
- Cream with CBD and natural ingredients, Cream without CBD and natural ingredients
- Keywords
- CBD, Cannabidiol, Triathlon, Chronic injuries, Running, Cycling, Swimming
- Medical subject headings
- Tendinopathy, Wounds and Injuries, Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cream with CBD and natural ingredientsOther
Also called Cream with CBD
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).
Cream without CBD and natural ingredientsOther
Also called Cream without CBD
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Cream with CBD and natural ingredients; Other: Cream without CBD and natural ingredients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Through the two 1-month intervention periods.
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: After the two 1-month intervention periods.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start18 Jan 2025
- Primary completion16 May 2025
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Collaborators
- Uriach Consumer Healthcare
- Responsible party
- Sponsor
- Investigators
- Javier Peña López, Ph.D., Principal investigator, Sport, Exercise, and Human Movement (SEaHM), University of Vic - Central University of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771076
- Sponsor's protocol ID
- CBDTRI001
- Status last verified
- May 2025
- First submitted
- 19 Dec 2024
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32060142Delgado 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.
PubMed 30211382McLean 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.
PubMed 20861526Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Development 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.
PubMed 9626712
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06771076
- Acronym / sponsor ID
- CBDTRI001
- Conditions
- Tendinopathy, Injuries, Chronic Pain, Sports, Physical Activity
- Keywords
- CBD, Cannabidiol, Triathlon, Chronic injuries, Running, Cycling, Swimming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Collaborators
- Uriach Consumer Healthcare
- Study start
- 18 Jan 2025 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cream with CBD and natural ingredients - Cream without CBD and natural ingredients | Experimental | Other: Cream with CBD and natural ingredients, Other: Cream without CBD and natural ingredientsDuring 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. |
| Cream without CBD and natural ingredients - Cream with CBD and natural ingredients | Experimental | Other: Cream with CBD and natural ingredients, Other: Cream without CBD and natural ingredientsDuring 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cream with CBD and natural ingredientsAlso: Cream with CBDTopical 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 | 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 ingredientsAlso: Cream without CBDTopical 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 | Cream with CBD and natural ingredients - Cream without CBD and natural ingredients, Cream without CBD and natural ingredients - Cream with CBD and natural ingredients |
Primary outcome
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).
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).
4 secondary outcomes
Effect of the cream on wellness
Time frame: Through the two 1-month intervention periods.
Effect of the cream on the perceived exertion
Time frame: Through the two 1-month intervention periods.
Effect of the cream on the quality of life
Time frame: After the two 1-month intervention periods.
Treatment assessment
Time frame: After the two 1-month intervention periods.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Background: PubMed 32060142Clarsen 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.
- Background: PubMed 30211382Delgado 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.
- Background: PubMed 20861526McLean 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.
- Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Background: PubMed 9626712Development 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Peña López, Ph.D. principal investigator
Sport, Exercise, and Human Movement (SEaHM), University of Vic - Central University of Catalonia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cream with CBD and natural ingredients and Cream without CBD and natural ingredients in people with Tendinopathy and Injuries, run by University of Vic - Central University of Catalonia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic effect of the cream (time frame: Through the two 1-month intervention periods.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06771076, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.