Chronic Musculoskeletal PainRECOVERNCT07733791
Real-world Evidence of Cannabinoid for Observed Pain Relief
An observational study of Chronic Musculoskeletal Pain and Delayed Onset Muscle Soreness (DOMS), run by Associação Pan-Americana Multidisciplinar de Endocanabinologia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Musculoskeletal Pain, Delayed Onset Muscle Soreness (DOMS)
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jul 2027
- How long will I take part?
- 90 Days
- Phase
- Observational
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Topical Use of Cannabinoids (CBD:THC 3:1) as Adjunctive Therapy for Chronic Muscle Pain in Athletes: A Comparative Prospective Observational Study
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.
Read more
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.
Read the detailed description
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.
POPULATION:
60 adult athletes (amateur or professional) practicing structured physical activity (≥3 sessions/week) for at least 6 months, with clinically confirmed chronic muscle pain (≥3 months duration), including myofascial pain syndrome, recurrent persistent DOMS, or pain from overtraining/repetitive microtrauma.
INTERVENTIONS OBSERVED:
Cohort A (Control, n=30): Full spectrum CBD oil, 60 mg/day, oral/sublingual, once daily at bedtime, for 90 days.
Cohort B (Intervention, n=30): Full spectrum CBD oil (same as Cohort A) PLUS Papa \& Barkley Topical Balm (450 mg CBD + 150 mg THC per 50 mL bottle; 9 mg CBD + 3 mg THC per mL), applied twice daily (every 12 hours) to the affected muscle area for 90 days.
ASSESSMENTS:
Evaluations at D0 (baseline), D7, D14, D30, D60, and D90 using validated instruments including BPI, NRS (0-10), PSQI, SF-36, TQR scale, LEFS/UEFI, rescue analgesic quantification, and structured adverse event reporting.
STATISTICAL ANALYSIS:
Mixed-effects models for repeated measures (MMRM) or Generalized Estimating Equations (GEE) will be used. Propensity score matching may be employed to mitigate confounding bias. Pre-specified subgroup analyses by sport modality, pain location, competitive level, and training volume.
ETHICS:
The protocol will be submitted to the Research Ethics Committee (CEP) via Plataforma Brasil, following CNS Resolutions 466⁄2012 and 510⁄2016.
Results will be reportedfollowing STROBE guidelines for observational studies.
- Keywords
- Topical Cannabinoids, Systemic Cannabidiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (Day 0) to end of follow-up (Day 90)
Secondary outcomes (6)
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.
Measured: From baseline (Day 0) to Day 90, with assessments at Days 7, 14, 30, 60, and 90
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.
Measured: From baseline (Day 0) to Day 90, with assessments at Days 30, 60, and 90
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.
Measured: From baseline (Day 0) to Day 90, with assessments at Days 30, 60, and 90
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).
Measured: From baseline (Day 0) to Day 90, with assessments at Days 7, 14, 30, 60, and 90
Sports Functional Capacity (LEFS/UEFI)
Sports functional capacity measured by the Lower Extremity Functional Scale (LEFS) or Upper Extremity Functional Index (UEFI), according to pain location. LEFS: 0-80 scale (higher = better function). UEFI: 0-80 scale (higher = better function).
Measured: From baseline (Day 0) to Day 90, with assessments at Days 30, 60, and 90
Safety and Tolerability (Adverse Events)
Structured recording of local and systemic adverse events, classified by severity (mild, moderate, severe) and causal relationship (definite, probable, possible, unlikely, unrelated). Includes monitoring of local skin reactions (dryness, erythema, pruritus, rash) and systemic effects (somnolence, diarrhea, nausea, appetite changes).
Measured: From Day 7 to Day 90, with continuous monitoring and assessments at Days 7, 14, 30, 60, and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Musculoskeletal PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Associação Pan-Americana Multidisciplinar de Endocanabinologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Wilson N V Andrade, MD, Principal investigator, Associação Pan-Americana Multidisciplinar de Endocanabinologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733791
- Sponsor's protocol ID
- APMCTOPICALCBD
- Acronym
- RECOVER
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data may be made available upon reasonable request to the principal investigator after study completion and publication of primary results.
Publications
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.
PubMed 39720705Rojas-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.
PubMed 37808192Hall 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.
PubMed 36991501