Real-world Evidence of Cannabinoid for Observed Pain Relief

NCT07733791 | Not Yet Recruiting

• 1 other identifier: APMCTOPICALCBD
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Musculoskeletal Pain; Delayed Onset Muscle Soreness (DOMS)

Keywords

Topical Cannabinoids; Systemic Cannabidiol

Outcome Measures

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.

  From baseline (Day 0) to end of follow-up (Day 90)

Secondary Outcomes (6)

• 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

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Associação Pan-Americana Multidisciplinar de Endocanabinologia: lead

Related Publications (3)

• Seevathee K, Kessomboon P, Manimmanakorn N, Luangphimai S, Thaneerat T, Wanaratna K, Plengphanich S, Thaenkham T, Sena W. Efficacy and Safety of Transdermal Medical Cannabis (THC:CBD:CBN formula) to Treat Painful Diabetic Peripheral Neuropathy of Lower Extremities. Med Cannabis Cannabinoids. 2024 Nov 14;8(1):1-14. doi: 10.1159/000542511. eCollection 2025 Jan-Dec.

  PMID: 39720705 BACKGROUND

• Rojas-Valverde D, Fallas-Campos A. Cannabidiol in sports: insights on how CBD could improve performance and recovery. Front Pharmacol. 2023 Sep 22;14:1210202. doi: 10.3389/fphar.2023.1210202. eCollection 2023. No abstract available.

  PMID: 37808192 BACKGROUND

• Hall N, James B, Bhuiyan MAN, Crane E, Falgout C, Murnane KS. Topical cannabidiol is well tolerated in individuals with a history of elite physical performance and chronic lower extremity pain. J Cannabis Res. 2023 Mar 30;5(1):11. doi: 10.1186/s42238-023-00179-8.

  PMID: 36991501 BACKGROUND

Related Links

• Product brand

Study Officials

• Jose Wilson N V Andrade, MD

  Associação Pan-Americana Multidisciplinar de Endocanabinologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Wilson N V Andrade, MD

CONTACT

+55 11 971905328; dr.jwilsonandrade@gmail.com

Aletheia B Pablos, DDS

CONTACT

+55 11 997426485; abpablos@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07