Topical Use of Cannabinoids (CBD:THC 3:1) as Adjunctive Therapy for Chronic Muscle Pain in Athletes: A Comparative Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Change in Chronic Muscle Pain Intensity and Interference (Brief Pain Inventory)
研究概览
简要总结
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.
详细描述
BACKGROUND:
Chronic muscle pain affects up to 70% of amateur and professional athletes over 12 months, with 7-day prevalence rates of approximately 32.8%. Conventional pharmacological therapies (NSAIDs, muscle relaxants, opioids) frequently provide inadequate relief and are associated with limiting systemic adverse effects. The endocannabinoid system (ECS) has emerged as a promising therapeutic target, with CB1 and CB2 receptors playing key roles in nociceptive modulation and neuroinflammation attenuation.
Topical cannabinoid administration offers the advantage of delivering high concentrations directly to peripheral receptors (CB1, CB2, and TRPV1) in nerve endings and immune cells of the skin and underlying muscle tissue, while minimizing systemic absorption. The combination of CBD and THC in a 3:1 ratio may maximize synergistic therapeutic effects (entourage effect) while mitigating psychotropic adverse effects.
STUDY DESIGN:
This is a prospective, comparative, non-randomized observational study with 90 days of follow-up per participant. Treatment allocation is based exclusively on the principal investigator's clinical decision, reflecting routine medical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Systemic CBD + Topical Balm (Intervention)
Athletes receiving standard cannabinoid therapy (Full spectrum CBD oil 60 mg/day oral/sublingual) plus adjuvant topical Papa & Barkley Cannabinoid Balm (CBD:THC 3:1; 9 mg CBD + 3 mg THC per mL), applied twice daily (every 12 hours) to the affected muscle area, for 90 continuous days.
Systemic CBD only - Control
Athletes receiving standard cannabinoid therapy only: Full spectrum CBD oil 60 mg/day (1 mL), oral/sublingual, once daily at bedtime, for 90 continuous days. No topical cannabinoid formulation prescribed.
结局指标
主要结局
Change in Chronic Muscle Pain Intensity and Interference (Brief Pain Inventory)
时间窗: From baseline (Day 0) to end of follow-up (Day 90)
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.
次要结局
- Pain Intensity (Numeric Rating Scale)(From baseline (Day 0) to Day 90, with assessments at Days 7, 14, 30, 60, and 90)
- Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)(From baseline (Day 0) to Day 90, with assessments at Days 30, 60, and 90)
- Quality of Life (SF-36)(From baseline (Day 0) to Day 90, with assessments at Days 30, 60, and 90)
- Perceived Muscle Recovery (Total Quality Recovery - TQR Scale)(From baseline (Day 0) to Day 90, with assessments at Days 7, 14, 30, 60, and 90)
- Sports Functional Capacity (LEFS/UEFI)(From baseline (Day 0) to Day 90, with assessments at Days 30, 60, and 90)
- Safety and Tolerability (Adverse Events)(From Day 7 to Day 90, with continuous monitoring and assessments at Days 7, 14, 30, 60, and 90)