Real-world Evidence of Cannabinoid for Observed Pain Relief (NCT07733791) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Real-world Evidence of Cannabinoid for Observed Pain Relief
60 participantsStarted 2027-01-01
Plain-language summary
Chronic muscle pain is one of the most prevalent clinical challenges in sports medicine, significantly affecting training capacity, competitive performance, and quality of life in athletes.
The endocannabinoid system has emerged as a promising therapeutic target for pain modulation in the sports context.
This prospective, comparative, non-randomized observational study aims to evaluate whether adjuvant topical application of a cannabinoid balm (CBD:THC 3:1 - Papa \& Barkley) provides additional reduction in chronic muscle pain intensity in athletes, compared to systemic CBD oil alone, over 90 days of follow-up in a real-world clinical practice setting.
Sixty adult athletes (amateur or professional) with established chronic muscle pain (≥3 months) who receive clinical indication for cannabinoid therapy will be followed in two observational cohorts: Cohort A (n=30), receiving only systemic CBD oil (60 mg/day oral/sublingual), and Cohort B, (n=30) receiving systemic CBD oil plus the topical cannabinoid balm (CBD:THC 3:1, applied twice daily to the affected muscle area).
Treatment allocation is based exclusively on the clinical decision of the principal investigator, reflecting routine medical practice. The primary outcome is the change in Brief Pain Inventory (BPI) scores from baseline (D0) to end of follow-up (D90). Secondary outcomes include pain intensity (NRS), sleep quality (PSQI), quality of life (SF-36), perceived muscle recovery (TQR scale), functional capacity (LEFS/UEFI), rescue analgesic use, and safety/tolerability of the topical formulation.
The study aims to generate real-world evidence on the effectiveness and safety of adjuvant topical cannabinoid therapy in athletes with chronic muscle pain in the Brazilian clinical practice setting.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Predominantly articular, bone, or non-muscular pain (e.g., fractures, degenerative arthropathies)
* Presence of open skin lesions, infections, or active dermatoses at the topical application site
* Current use of WADA-prohibited substances that may interfere with outcome assessment
* Athletes in official competition during the study period using THC-containing formulations (due to WADA in-competition prohibition)
* Severe acute musculoskeletal injury (complete muscle rupture, fracture) within the last 30 days
* Cognitive or technological inability to use the follow-up platform
Exclusion Criteria:
* Predominantly articular, bone, or non-muscular pain (e.g., fractures, degenerative arthropathies)
* Presence of open skin lesions, infections, or active dermatoses at the topical application site
* Current use of WADA-prohibited substances that may interfere with outcome assessment
* Athletes in official competition during the study period using THC-containing formulations (due to WADA in-competition prohibition)
* Severe acute musculoskeletal injury (complete muscle rupture, fracture) within the last 30 days
* Cognitive or technological inability to use the follow-up platform
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Chronic Muscle Pain Intensity and Interference (Brief Pain Inventory)
Timeframe: From baseline (Day 0) to end of follow-up (Day 90)
Trial details
NCT IDNCT07733791
SponsorAssociação Pan-Americana Multidisciplinar de Endocanabinologia