Real-world Evidence of Cannabinoid for Observed Pain Relief
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssociação Pan-Americana Multidisciplinar de Endocanabinologia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial population
Adult athletes (amateur or professional) practicing structured physical activity (minimum 3 sessions per week) for at least 6 months, with performance, competition, or high physical performance objectives, and with an established clinical diagnosis of chronic muscle pain (≥3 months duration). Participants are recruited from the clinical practice of the principal investigator in Brazil.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Systemic CBD only - Control
Group B: Systemic CBD + Topical Balm (Intervention)
Trial outcomes
Primary outcomes
1
Change in Chronic Muscle Pain Intensity and Interference (Brief Pain Inventory)
Change in Brief Pain Inventory (BPI) scores - pain intensity dimension (worst, least, average, current pain on 0-10 scale) and pain interference dimension (7 items on 0-10 scale assessing interference with general activity, mood, walking, work, relations, sleep, and enjoyment of life) - from baseline (D0) to end of follow-up (D90). Higher scores indicate worse pain/interference. A clinically meaningful change is defined as ≥2 points reduction in pain intensity.
Time frame
From baseline (Day 0) to end of follow-up (Day 90)Secondary outcomes
1
Pain Intensity (Numeric Rating Scale)
Pain intensity measured by the Numeric Rating Scale (NRS 0-10), where 0 = no pain and 10 = worst imaginable pain. Assessed at D0, D7, D14, D30, D60, and D90.
Time frame
From baseline (Day 0) to Day 90, with assessments at Days 7, 14, 30, 60, and 902
Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)
Sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-report questionnaire assessing sleep quality over a 1-month interval, consisting of 19 items creating 7 components producing a global score (0-21). Scoring: 0-5 = good sleep quality; 6- 10 = poor sleep quality; 11-21 = sleep disorder indication. Lower scores indicate better sleep quality.
Time frame
From baseline (Day 0) to Day 90, with assessments at Days 30, 60, and 903
Quality of Life (SF-36)
Health-related quality of life measured by the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). The SF-36 assesses 8 physical and mental health domains, scored from 0 (worst health) to 100 (best health). Higher scores indicate better quality of life.
Time frame
From baseline (Day 0) to Day 90, with assessments at Days 30, 60, and 904
Perceived Muscle Recovery (Total Quality Recovery - TQR Scale)
Perceived muscle recovery measured by the Total Quality Recovery (TQR) scale of Kenttä \& Hassmén. The TQR is a single-item scale (6-20) that assesses the athlete's perceived recovery status. Higher scores indicate better perceived recovery (6 = very, very poor recovery; 20 = very, very good recovery).
Time frame
From baseline (Day 0) to Day 90, with assessments at Days 7, 14, 30, 60, and 90Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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